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The study proposes to recruit 90 children and young people who have type 1 diabetes (T1D) and who regularly use Dexcom continuous glucose monitoring (CGM). The participants will be recruited from National Health Service (NHS) sites in the United Kingdom (UK) via their managing dietitian. The dietitian will be asked to provide baseline information about the participants which will include demographic data and information on clinical data, treatment and anthropometrics. Participants will be asked to provide access to Dexcom CGM data throughout the period of recording. Participants will be asked to test three breakfast meals (high glycaemic load, high glycaemic with 10g added protein and medium glycaemic load) plus a control meal (usual breakfast), repeating each meal twice in a randomized order using a Latin square randomisation. The dietitian will be asked to optimise the participants insulin doses prior to commencing test meals. Participants will be asked to complete a questionnaire for each of the postprandial test and control meal periods. This will include questions about their diabetes management, food and fluid intake in addition to questions on activities all of which took place during the three-hour postprandial period. The glycaemic response to the test and control meals will be analysed using the CGM data and the results statistically described using univariate, bivariate and multivariate analysis.
This is a quantitative study. Dexcom CGM data will be collected for the period of recording. Participants will be asked to test three breakfast meals on two occasions and submit a postprandial questionnaire after each test meal to confirm it has been tested. The postprandial period will be three hours following the end of the breakfast test meal. The test meal recipes will be provided by the chief investigator. The dietary composition of the meals has been analysed using the a dietary analysis programme. The glycaemic index and load of the meals is estimated from this programme which uses available date from the international tables of glycaemic index and glycaemic loads (Atkinson et al. 2008; 2021). Most foods were based on average composition across different brands. For the added fibre bread used in test meal 3, an average of three known brands was used calculated by the chief investigator. The meals will be taken in the home environment with the food provided by the families. The participants will be asked to take the test meal on a day when their CGM reading is between 4-10mmol/l and when there has been no nocturnal hypoglycaemia on the night before the planned test. The participants will act as their own control. They will be asked to complete a postprandial questionnaire for control meals as well. The control meals will be there usual breakfast of choice. The study duration, commencing with the recruitment of the first participant and ending when data has been fully described, is anticipated to be two years.
Recruitment Paediatric diabetes dietitians, working across the UK, will be enrolled to help recruit participants and become principal investigators (PI) for their site.
Sample size The sample size power calculation is 64. This is based on using ANOVA repeated measures, within factors with four groups and measurements (3 test meals and control) with small effect size (0.15), P value 0.05 and power 0.80 and correlation among repeated measure of 0.5. The drop rate of clinical trials is often over 40%. Therefore, the aim is to recruit 90 participants to allow for this dropout rate and meet the sample size of 64. It may be possible to recruit this number of participants. There are approximately 29,000 children and young people living in the UK with T1D (Juvenile Diabetes Research Federation (JDRF), 2018). In the first phase of this study, 12 NHS sites were enrolled, and 96 children and young people were recruited to the study.
Methodology Baseline data
In order to make comparisons between relevant variables and glucose levels, the following baseline data will be collected from the dietitians and sent to the chief investigator, along with the artificial identifier on the Excel spreadsheet as discussed earlier at the stage of recruitment of participants:
Run-in period At recruitment the dietitians will be asked to arrange a review of the participants insulin regimen including the insulin to carbohydrate ratio's (ICR), insulin sensitivity factor (ISF) and basal background insulin doses/rates. The dietitian will be asked to inform the chief investigator when this has taken place. Participants will be asked to commence the test meals following this.
Glucose measurement Data on interstitial glucose will be collected via Dexcom CGM. The Dexcom CGM data will be accessed by an NHS Highland research 'Clarity Clinic' with Dexcom CLARITY® Clinic Portal (Dexcom In, San Diego, California (CA), USA). The chief investigator is administrator of this clinic. Once the managing dietitian has obtained each participant's consent, the participant's parent's email address will be sent to the chief investigator along with the baseline information/data as described above. The chief investigator, as administrator of the Clarity Clinic account, will then invite the participant, via email, to be added to the clinic. Once the invite has been accepted, it will stand for the period of the recording i.e. until all the test meals and questionnaires have been completed. Once the participant has submitted their last questionnaire, they will be removed from the Dexcom CLARITY® Clinic Portal.
Following the provision of CGM data and review of the insulin regimen by the diabetes team, participants will be randomised to test each of the three test meals on two separate occasions with a control meal (usual breakfast meal) for each test meal. Randomisation will be achieved using a Latin square randomisation. The tool used for this will be http://www.jerrydallal.com/random/randomize.htm. Randomisation will be done in a block of four.
The test meals are based on foods children and young people enjoy eating. There are three meals. Test meal one includes a high glycaemic index cereal meal with milk and has a high glycaemic load (> 20), test meal two is the same cereal meal with a high glycaemic load (>20) with addition of 10g protein and test meal three has a medium glycaemic load (10-20). For test meals one and two there are three portion size options to meet age appropriate requirements and appetites. The participants will be able to choose from two different cereals for test meal 1 and a choice of protein sources for test meal 2. They will be asked to keep to the same choice of cereal and protein source for the repeat meal. They will be asked to consume at least 75% of the meal to ensure the threshold of the glycaemic load is met. The instructions and details of the test meals are presented in Appendix 11. The control meals will be the participant's usual breakfast of choice.
Participants will be asked to follow their usual insulin regimen as advised by their diabetes team i.e. their usual insulin dose and dose timing. For both test and control meals participants will be asked to avoid any further food intake during three-hour postprandial period other than carbohydrate adjustments required to treat any hypoglycaemia. Participants will also be asked to avoid drinks except water or carbohydrate free juices. They will also be asked to avoid physical activity of more than 30 minutes in duration. To minimise disruption to their normal daily activities, they will be advised to test the meal on a day when there is no planned physical activity i.e. a school day with no morning physical education. The CGM data will be collected throughout this time as discussed above.
Postprandial Questionnaire The participants will be asked to complete a postprandial questionnaire using 'online survey'. This includes questions about the meal and the three-hour postprandial period. The questionnaire is presented in Appendix 10. They will be asked to wait a minimum of three hours before answering and submitting the questionnaire. They will be encouraged to complete it on the same day as the test or control meal.
Data analysis This will be a mix of univariate, bivariate and multivariate analysis as this is best suited to describing, summarising and visualising these data. Outputs will include the distribution of glucose levels post-breakfast to determine the spread and dispersion of the data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breakfast meals | Other | All the study participants received in an individual randomised order test breakfast meals: Test Meal 1 high glycaemic load (HGL), Test Meal 2 high glycaemic load with 10g protein (HGLP), Test Meal 3 medium glycaemic load (MGL) and control meal (usual breakfast). There was no wash out period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breakfast meals | Other | Test meal 1: HGL Test meal 2: HGLP Test meal 3: MGL Control meal: usual breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Glucose (mmol/l) | This is the mean glucose over the 3 hour postprandial period taken from CGM readings taken every 5 minutes | three-hour postprandial breakfast period |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Glucose Excursion | This is the mean excursion over the 3 hour postprandial period taken from CGM readings taken every 5 minutes | three-hour postprandial breakfast period |
| Mean Peak Glucose Excursion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Johnson, MNutr | University of Stirling | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Health Sciences and Sport | Stirling | Stirlingshire | FK9 4LA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18835944 | Background | Atkinson FS, Foster-Powell K, Brand-Miller JC. International tables of glycemic index and glycemic load values: 2008. Diabetes Care. 2008 Dec;31(12):2281-3. doi: 10.2337/dc08-1239. Epub 2008 Oct 3. | |
| 34258626 | Background | Atkinson FS, Brand-Miller JC, Foster-Powell K, Buyken AE, Goletzke J. International tables of glycemic index and glycemic load values 2021: a systematic review. Am J Clin Nutr. 2021 Nov 8;114(5):1625-1632. doi: 10.1093/ajcn/nqab233. |
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Following recruitment participants were allocated to a randomised sequence for testing the meals. Randomisation was in a block of four. Of the participants who tested the meals this resulted in 18 different sequences of meal order.
Participants diabetes management was optimised at the time of recruitment to ensure that the insulin doses for the breakfast meal were accurate
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| ID | Title | Description |
|---|---|---|
| FG000 | Breakfast Meals | Test and control meals - Participants were asked to repeat the meals in the allocated randomized order before moving to the next meal e.g. control meal x 2, TM1 x 2 TM3 x 2 and TM2 x 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Breakfast Meals | Test and control meals |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Glucose (mmol/l) | This is the mean glucose over the 3 hour postprandial period taken from CGM readings taken every 5 minutes | CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20 | Posted | Mean | Standard Deviation | mmol/l | three-hour postprandial breakfast period | Breakfast meals | Breakfast meals |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Breakfast Meals | Test and control meals | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Johnson | University of Stirling | 07815893076 | julie.johnson1@stir.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2022 | Aug 5, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 8, 2022 | Aug 5, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D062408 | Breakfast |
| ID | Term |
|---|---|
| D062407 | Meals |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Participants will be asked to test each of the three test meals and control meal (usual breakfast) on two occasions. The meals will be consumed in an individual randomised order with the randomisation achieved using a Latin square randomisation. The tool used for this will be http://www.jerrydallal.com/random/randomize.htm. Randomisation will be done in a block of four.
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This is the peak excursion over the 3 hour postprandial period taken from CGM readings taken every 5 minutes
| three-hour postprandial breakfast period |
| Mean Time to Peak | This is the time it took the glucose to peak (reach it's highest excursion from baseline) over the 3 hour postprandial period taken from CGM readings taken every 5 minutes | three-hour postprandial breakfast period |
| Area Under the Glucose Curve | This is incremental area under the glucose curve above baseline over the 3 hour postprandial period taken from CGM readings taken every 5 minutes | three-hour postprandial breakfast period |
| Percentage Coefficient of Variation | This is used to assess glucose variability over the three hour postprandial period taken from CGM readings taken every 5 mins | 3 hours |
| Time in Range | This is the time in minutes that was spent with a glucose in range (3.9-10mmol/l over the 3 hours postprandial period | three-hour postprandial breakfast period |
| Time Above Range | This is the time that the glucose was above range (>10mmol/l) during the 3 hours postprandial period taken from CGM readings taken every 5 minutes | 3 hours |
| Time in Tight Range | This the time of glucose reading spent in tight range (3.9-7.8mmol/l) over the three hour postprandial period from CGM readings taken every 5 minutes | 3 hours |
| Glucose at 30 Minutes | Postprandial glucose excursion taken from CGM readings at 30 minutes after the meal commenced | 30 minutes |
| Glucose at 60 Minutes | Postprandial glucose excursion taken from CGM readings at 60 minutes after the meal commenced | 60 minutes |
| Glucose at 90 Minutes | Postprandial glucose excursion taken from CGM readings at 90 minutes after the meal commenced | 90 minutes |
| Glucose at 120 Minutes | Postprandial glucose excursion taken from CGM readings at 120 minutes after the meal commenced | 120 minutes |
| Glucose at 150 Minutes | Postprandial glucose excursion taken from CGM readings at 150 minutes after the meal commenced | 150 minutes |
| Glucose at 180 Minutes | Postprandial glucose excursion taken from CGM readings at 180 minutes after the meal commenced | 180 minutes |
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| 31838460 | Background | Toh DWK, Koh ES, Kim JE. Lowering breakfast glycemic index and glycemic load attenuates postprandial glycemic response: A systematically searched meta-analysis of randomized controlled trials. Nutrition. 2020 Mar;71:110634. doi: 10.1016/j.nut.2019.110634. Epub 2019 Nov 1. |
| 10871567 | Background | van Loon LJ, Saris WH, Verhagen H, Wagenmakers AJ. Plasma insulin responses after ingestion of different amino acid or protein mixtures with carbohydrate. Am J Clin Nutr. 2000 Jul;72(1):96-105. doi: 10.1093/ajcn/72.1.96. |
| 8198048 | Background | Wolever TM, Nguyen PM, Chiasson JL, Hunt JA, Josse RG, Palmason C, Rodger NW, Ross SA, Ryan EA, Tan MH. Determinants of diet glycemic index calculated retrospectively from diet records of 342 individuals with non-insulin-dependent diabetes mellitus. Am J Clin Nutr. 1994 Jun;59(6):1265-9. doi: 10.1093/ajcn/59.6.1265. |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| HbA1c | Mean | Standard Deviation | mmol/mol |
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| Disease duration | Mean | Standard Deviation | Years |
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| Insulin regimen | Count of Participants | Participants |
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| Type of insulin pump (CSII) | Count of Participants | Participants |
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| Units |
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| Counts |
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| Participants |
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| Breakfast meals |
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| Secondary | Mean Glucose Excursion | This is the mean excursion over the 3 hour postprandial period taken from CGM readings taken every 5 minutes | CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20 | Posted | Mean | Standard Deviation | mmol/l | three-hour postprandial breakfast period | Breakfast meals | Breakfast meals |
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| Secondary | Mean Peak Glucose Excursion | This is the peak excursion over the 3 hour postprandial period taken from CGM readings taken every 5 minutes | CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20 | Posted | Mean | Standard Deviation | mmol/l | three-hour postprandial breakfast period | Breakfast meals | Breakfast meals |
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| Secondary | Mean Time to Peak | This is the time it took the glucose to peak (reach it's highest excursion from baseline) over the 3 hour postprandial period taken from CGM readings taken every 5 minutes | CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20 | Posted | Mean | Standard Deviation | Minutes | three-hour postprandial breakfast period | Breakfast meals | Breakfast meals |
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| Secondary | Area Under the Glucose Curve | This is incremental area under the glucose curve above baseline over the 3 hour postprandial period taken from CGM readings taken every 5 minutes | CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20 | Posted | Mean | Standard Deviation | (mmol/l)*min | three-hour postprandial breakfast period | Breakfast meals | Breakfast meals |
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| Secondary | Percentage Coefficient of Variation | This is used to assess glucose variability over the three hour postprandial period taken from CGM readings taken every 5 mins | CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20 | Posted | Mean | Standard Deviation | percentage | 3 hours | Breakfast meals | Breakfast meals |
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| Secondary | Time in Range | This is the time in minutes that was spent with a glucose in range (3.9-10mmol/l over the 3 hours postprandial period | CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20 | Posted | Mean | Standard Deviation | Minutes | three-hour postprandial breakfast period | Breakfast meals | Breakfast meals |
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| Secondary | Time Above Range | This is the time that the glucose was above range (>10mmol/l) during the 3 hours postprandial period taken from CGM readings taken every 5 minutes | CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20 | Posted | Mean | Standard Deviation | Minutes | 3 hours | Breakfast meals | Breakfast meals |
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| Secondary | Time in Tight Range | This the time of glucose reading spent in tight range (3.9-7.8mmol/l) over the three hour postprandial period from CGM readings taken every 5 minutes | CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20 | Posted | Mean | Standard Deviation | Minutes | 3 hours | Breakfast meals | Breakfast meals |
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| Secondary | Glucose at 30 Minutes | Postprandial glucose excursion taken from CGM readings at 30 minutes after the meal commenced | CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20 | Posted | Mean | Standard Deviation | mmol/l | 30 minutes | Breakfast meals | Breakfast meals |
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| Secondary | Glucose at 60 Minutes | Postprandial glucose excursion taken from CGM readings at 60 minutes after the meal commenced | CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20 | Posted | Mean | Standard Deviation | mmol/l | 60 minutes | Breakfast meals | Breakfast meals |
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| Secondary | Glucose at 90 Minutes | Postprandial glucose excursion taken from CGM readings at 90 minutes after the meal commenced | CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20 | Posted | Mean | Standard Deviation | mmol/l | 90 minutes | Breakfast meals | Breakfast meals |
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| Secondary | Glucose at 120 Minutes | Postprandial glucose excursion taken from CGM readings at 120 minutes after the meal commenced | CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20 | Posted | Mean | Standard Deviation | mmol/l | 120 minutes | Breakfast meals | Breakfast meals |
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| Secondary | Glucose at 150 Minutes | Postprandial glucose excursion taken from CGM readings at 150 minutes after the meal commenced | CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20 | Posted | Mean | Standard Deviation | mmol/l | 150 minutes | Breakfast meals | Breakfast meals |
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| Secondary | Glucose at 180 Minutes | Postprandial glucose excursion taken from CGM readings at 180 minutes after the meal commenced | CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20 | Posted | Mean | Standard Deviation | mmol/l | 180 minutes | Breakfast meals | Breakfast meals |
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| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
Not provided
Not provided
| D019602 |
| Food and Beverages |
| Test meal 2 (HGLP) |
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| Test meal 3 (MGL) |
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| Control meal (usual breakfast) |
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| Linear Mixed Model |
| 0.13 |
The a priori threshold for statistical significance p<0.05 |
| Mean Difference (Final Values) |
| -0.7 |
| 2-Sided |
| 95 |
| -1.7 |
| 0.2 |
| Other |
| MGL meals vs control meals | Linear Mixed Model | 0.68 | The a priori threshold for statistical significance p<0.05 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -1.2 | 0.8 | Other |
| HGL vs HGLP meals | Linear Mixed Model | <0.01 | The a priori threshold for statistical significance p<0.05 P value adjusted with Bonferroni correction | Mean Difference (Final Values) | 1.6 | 2-Sided | 95 | 0.7 | 2.5 | Other |
| HGL vs MGL meals | Linear Mixed Model | 0.06 | The a priori threshold for statistical significance p<0.05 p value adjusted with the Bonferroni correction | Mean Difference (Final Values) | 1.1 | 2-Sided | 95 | 0.2 | 2.0 | Other |
| HGLP vs MGL meals | Linear Mixed Model | 0.29 | a priori threshold for statistical significance - P<0.05 | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -1.4 | 0.4 | Other |
| Test meal 2 (HGLP) |
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| Test meal 3 (MGL) |
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| Control meal (usual breakfast) |
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| Linear Mixed Model |
| 0.59 |
A priori threshold for statistical significance is p<0.05 |
| Mean Difference (Final Values) |
| -0.3 |
| 2-Sided |
| 95 |
| -1.4 |
| 0.8 |
| Other |
| MGL meals vs control meals | Linear Mixed Model | 0.86 | A priori threshold for statistical significance is p<0.05 | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -1.2 | 1.0 | Other |
| HGL vs HGLP meals | Linear Mixed Model | <0.001 | A priori threshold for statistical significance is p<0.05 Adjustment with Bonferroni did not alter p value | Mean Difference (Final Values) | 2.3 | 2-Sided | 95 | 1.2 | 3.3 | Other |
| HGL vs MGL meals | Linear Mixed Model | <0.001 | A priori threshold for statistical significance is p<0.05 Adjustment with Bonferroni correction did not alter p value | Mean Difference (Final Values) | 2.1 | 2-Sided | 95 | 1.1 | 3.1 | Other |
| HGLP vs MGL meals | Linear Mixed Model | 0.79 | A priori threshold for statistical significance is p<0.05 | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -1.2 | 0.9 | Other |
| Test meal 2 (HGLP) |
|
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| Test meal 3 (MGL) |
|
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| Control meal (usual breakfast) |
|
|
| Linear Mixed Model |
| 0.03 |
A priori threshold for statistical significance is p<0.05 P adjusted using Bonferroni correction |
| Mean Difference (Final Values) |
| -24.4 |
| 2-Sided |
| 95 |
| -41 |
| -8 |
| Other |
| MGL meals vs control meals | Linear Mixed Model | 0.14 | A priori threshold for statistical significance is p<0.05 | Mean Difference (Final Values) | 12.7 | 2-Sided | 95 | -4.1 | 29.5 | Other |
| HGL vs HGLP meals | Linear Mixed Model | 0.34 | A priori threshold P <0.05 P value adjusted with Bonferroni correction | Mean Difference (Final Values) | 17 | 2-Sided | 95 | 3.1 | 31.7 | Other |
| HGL vs MGL meals | Linear Mixed Model | 0.07 | A priori threshold for statistical significance is p<0.05 Adjusted P value with Bonferroni correction | Mean Difference (Final Values) | -19 | 2-Sided | 95 | -33.3 | -4.7 | Other |
| HGLP vs MGL meals | Linear Mixed Model | <0.001 | A priori threshold for statistical significance is p<0.05 Adjustment with Bonferroni did not alter p value | Mean Difference (Final Values) | -36.4 | 2-Sided | 95 | -51.0 | -21.8 | Other |
| Test meal 2 (HGLP) |
|
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| Test meal 3 (MGL) |
|
|
| Control meal (usual breakfast) |
|
|
| Linear Mixed Model |
| 0.15 |
A priori threshold for statistical significance is p<0.05 |
| Mean Difference (Final Values) |
| -109 |
| 2-Sided |
| 95 |
| -256 |
| 38 |
| Other |
| MGL meals vs control meals | Linear Mixed Model | 0.69 | A priori threshold for statistical significance is p<0.05 | Mean Difference (Final Values) | -30 | 2-Sided | 95 | -177 | 117 | Other |
| HGL vs HGLP meals | Linear Mixed Model | <0.001 | A priori threshold for statistical significance is p<0.05 Adjustment with Bonferroni did not alter p value | Mean Difference (Final Values) | 264 | 2-Sided | 95 | 126 | 401 | Other |
| HGL vs MGL meals | Linear Mixed Model | 0.02 | A priori threshold for statistical significance is p<0.05 P value adjusted with Bonferroni correction | Mean Difference (Final Values) | 192 | 2-Sided | 95 | 56 | 329 | Other |
| HGLP vs MGL meals | Linear Mixed Model | 0.32 | A priori threshold for statistical significance is p<0.05 | Mean Difference (Final Values) | -71 | 2-Sided | 95 | -211 | 69 | Other |
| Test meal 2 (HGLP) |
|
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| Test meal 3 (MGL) |
|
|
| Control meal (usual breakfast) |
|
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| Linear Mixed Model |
| 0.06 |
A priori threshold for statistical significance is p<0.05 |
| Mean Difference (Final Values) |
| 3.5 |
| 2-Sided |
| 95 |
| -0.2 |
| 7.2 |
| Other |
| MGL meals vs control meals | Linear Mixed Model | 0.86 | A priori threshold for statistical significance is p<0.05 | Mean Difference (Final Values) | 0.32 | 2-Sided | 95 | -3.3 | 3.9 | Other |
| HGL vs HGLP meals | Linear Mixed Model | 0.11 | A priori threshold for statistical significance is p<0.05 P value adjusted with the Bonferroni correction | Mean Difference (Final Values) | 3.4 | 2-Sided | 95 | 0.24 | 6.48 | Other |
| HGL vs MGL meals | Linear Mixed Model | <0.001 | A priori threshold for statistical significance is p<0.05 Adjustment with Bonferroni did not alter p value | Mean Difference (Final Values) | 6.7 | 2-Sided | 95 | 3.6 | 9.8 | Other |
| HGLP vs MGL meals | Linear Mixed Model | 0.13 | A priori threshold for statistical significance is p<0.05 Adjustment with Bonferroni correction | Mean Difference (Final Values) | 3.3 | 2-Sided | 95 | 0.2 | 6.5 | Other |
| Test meal 2 (HGLP) |
|
|
| Test meal 3 (MGL) |
|
|
| Control meal (usual breakfast) |
|
|
| Linear Mixed Model |
| 0.87 |
A priori threshold for statistical significance is p<0.05 |
| Mean Difference (Final Values) |
| -1.8 |
| 2-Sided |
| 95 |
| -23.6 |
| 19.9 |
| Other |
| MGL meals vs control meals | Linear Mixed Model | 0.67 | A priori threshold for statistical significance is p<0.05 | Mean Difference (Final Values) | -4.7 | 2-Sided | 95 | -26.4 | 17.0 | Other |
| HGL vs HGLP meals | Linear Mixed Model | 0.01 | A priori threshold for statistical significance is p<0.05 Adjustment with Bonferroni correction | Mean Difference (Final Values) | -33.3 | 2-Sided | 95 | -54.4 | -12.2 | Other |
| HGL vs MGL meals | Linear Mixed Model | 0.01 | A priori threshold for statistical significance is p<0.05 Adjustment with Bonferroni correction | Mean Difference (Final Values) | -31.4 | 2-Sided | 95 | -52.4 | -10.4 | Other |
| HGLP vs MGL meals | Linear Mixed Model | 0.87 | A priori threshold for statistical significance is p<0.05 | Mean Difference (Final Values) | 1.86 | 2-Sided | 95 | -19.7 | 23.4 | Other |
| Test meal 2 (HGLP) |
|
|
| Test meal 3 (MGL) |
|
|
| Control meal (usual breakfast) |
|
|
| 0.56 |
| Mean Difference (Final Values) |
| 6 |
| 2-Sided |
| 95 |
| -17 |
| 30 |
| Other |
| Control vs MGL meals | t-test, 2 sided | 0.22 | Mean Difference (Final Values) | 12 | 2-Sided | 95 | 8 | 32 | Other |
| HGL vs HGLP meals | t-test, 2 sided | 0.01 | Mean Difference (Final Values) | 38 | 2-Sided | 95 | 10 | 67 | Other |
| HGL vs MGL meals | t-test, 2 sided | 0.03 | Mean Difference (Final Values) | 33 | 2-Sided | 95 | 4 | 62 | Other |
| HGLP vs MGL meals | t-test, 2 sided | 0.63 | Mean Difference (Final Values) | -5 | 2-Sided | 95 | -29 | 18 | Other |
| Test meal 2 (HGLP) |
|
|
| Test meal 3 (MGL) |
|
|
| Control meal (usual breakfast) |
|
|
| 0.11 |
| Mean Difference (Final Values) |
| 21 |
| 2-Sided |
| 95 |
| 5 |
| 46 |
| Other |
| Control vs MGL meals | t-test, 2 sided | 0.15 | Mean Difference (Final Values) | 19 | 2-Sided | 95 | 8 | 45 | Other |
| HGL vs HGLP meals | t-test, 2 sided | <0.01 | Mean Difference (Final Values) | 44 | 2-Sided | 95 | 16 | 71 | Other |
| HGL vs MGL meals | t-test, 2 sided | 0.60 | Mean Difference (Final Values) | -7 | 2-Sided | 95 | -36 | 21 | Other |
| HGLP vs MGL meals | t-test, 2 sided | 0.02 | Mean Difference (Final Values) | 29 | 2-Sided | 95 | 6 | 51 | Other |
| Test meal 2 (HGLP meal) |
|
|
| Test meal 3 (MGL meal) |
|
|
| Control meal |
|
|
| Linear Mixed Model |
| 0.38 |
| Mean Difference (Final Values) |
| 0.4 |
| 2-Sided |
| 95 |
| -0.5 |
| 1.2 |
| Other |
| MGL meal excursion vs Control meal at 30 minutes | Linear Mixed Model | 0.47 | a priori threshold for statistical significance p<0.05 | Mean Difference (Final Values) | -0.3 | 2-Sided | 95 | -1.1 | 0.5 | Other |
| HGL meal vs HGLP meal | Linear Mixed Model | 0.01 | a priori threshold for statistical significance p<0.05 P value adjusted with Bonferroni correction | Mean Difference (Final Values) | 1.2 | 2-Sided | 95 | 0.5 | 2.0 | Other |
| HGL meal vs MGL meals | Linear Mixed Model | <0.001 | a priori threshold for statistical significance p<0.05 | Mean Difference (Final Values) | 1.9 | 2-Sided | 95 | 1.1 | 2.6 | Other |
| HGLP meals vs MGL meals | Linear Mixed Model | 0.09 | a priori threshold for statistical significance p<0.05 | Mean Difference (Final Values) | 0.7 | 2-Sided | 95 | 0.1 | 1.4 | Other |
| Test meal 2 (HGLP meal) |
|
|
| Test meal 3 (MGL meal) |
|
|
| Control meal |
|
|
| Linear Mixed Model |
| 0.87 |
a priori threshold for statistical significance p<0.05 |
| Mean Difference (Final Values) |
| -0.1 |
| 2-Sided |
| 95 |
| -1.2 |
| 1.0 |
| Other |
| MGL meals vs control meals | Linear Mixed Model | 0.48 | a priori threshold for statistical significance p<0.05 | Mean Difference (Final Values) | -0.4 | 2-Sided | 95 | -1.5 | 0.7 | Other |
| HGL meals vs HGLP meals | Linear Mixed Model | <0.001 | a priori threshold for statistical significance p<0.05 | Mean Difference (Final Values) | 2.0 | 2-Sided | 95 | 1.0 | 3.1 | Other |
| HGL meals vs MGL meals | Linear Mixed Model | <0.001 | a priori threshold for statistical significance p<0.05 | Mean Difference (Final Values) | 2.4 | 2-Sided | 95 | 1.3 | 3.4 | Other |
| MGL meals vs HGLP meals | Linear Mixed Model | 0.53 | a priori threshold for statistical significance p<0.05 | Mean Difference (Final Values) | -0.34 | 2-Sided | 95 | -1.4 | 0.7 | Other |
| Test meal 2 (HGLP meal) |
|
|
| Test meal 3 (MGL meal) |
|
|
| Control meal |
|
|
| Linear Mixed Model |
| 0.13 |
a priori threshold for statistical significance p<0.05 |
| Mean Difference (Final Values) |
| -1.1 |
| 2-Sided |
| 95 |
| -2.5 |
| 0.3 |
| Other |
| MGL meals vs control meals | Linear Mixed Model | 0.82 | a priori threshold for statistical significance p<0.05 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -1.5 | 1.2 | Other |
| HGL meals vs MGL meals | Linear Mixed Model | <0.01 | a priori threshold for statistical significance p<0.05 Adjusted with Bonferroni correction | Mean Difference (Final Values) | 2.4 | 2-Sided | 95 | 1.1 | 3.7 | Other |
| HGL meals vs MGL meals | Linear Mixed Model | 0.08 | a priori threshold for statistical significance p<0.05 Adjusted with Bonferroni correction | Mean Difference (Final Values) | 1.5 | 2-Sided | 95 | 0.2 | 2.9 | Other |
| MGL meals vs HGLP meals | Linear Mixed Model | 0.21 | a priori threshold for statistical significance p<0.05 | Mean Difference (Final Values) | 0.9 | 2-Sided | 95 | -0.5 | 2.2 | Other |
| Test meal 2 (HGLP meal) |
|
|
| Test meal 3 (MGL meal) |
|
|
| Control meal |
|
|
| Linear Mixed Model |
| 0.05 |
a priori threshold for statistical significance p<0.05 |
| Mean Difference (Final Values) |
| -1.5 |
| 2-Sided |
| 95 |
| -3.0 |
| -0.1 |
| Other |
| MGL meals vs control meals | Linear Mixed Model | 0.97 | a priori threshold for statistical significance p<0.05 | Mean Difference (Final Values) | 0.03 | 2-Sided | 95 | -1.5 | 1.5 | Other |
| HGL meals vs HGLP meals | Linear Mixed Model | <0.01 | a priori threshold for statistical significance p<0.05 Adjusted with Bonferroni correction | Mean Difference (Final Values) | 2.3 | 2-Sided | 95 | 1.0 | 3.6 | Other |
| HGL meals vs MGL meals | Linear Mixed Model | 0.27 | a priori threshold for statistical significance p<0.05 | Mean Difference (Final Values) | 0.8 | 2-Sided | 95 | 0.6 | 2.2 | Other |
| MGL meals vs HGLP meals | Linear Mixed Model | 0.12 | a priori threshold for statistical significance <0.05 Adjusted with p value | Mean Difference (Final Values) | 1.5 | 2-Sided | 95 | 0.1 | 3.0 | Other |
| Test meal 2 (HGLP meal) |
|
|
| Test meal 3 (MGL meal) |
|
|
| Control meal |
|
|
| Linear Mixed Model |
| 0.09 |
a priori threshold for statistical significance <0.05 Adjusted with Bonferroni correction |
| Mean Difference (Final Values) |
| -1.5 |
| 2-Sided |
| 95 |
| -2.9 |
| -0.2 |
| Other |
| MGL meals vs control meals | Linear Mixed Model | 0.78 | a priori threshold for statistical significance <0.05 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -1.6 | 1.2 | Other |
| HGL meals vs HGLP meals | Linear Mixed Model | 0.11 | a priori threshold for statistical significance <0.05 Adjusted with Bonferroni correction | Mean Difference (Final Values) | 1.4 | 2-Sided | 95 | 0.1 | 2.7 | Other |
| MGL meals vs HGL meals | Linear Mixed Model | 0.82 | a priori threshold for statistical significance <0.05 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -1.5 | 1.1 | Other |
| MGL meals vs HGLP meals | Linear Mixed Model | 0.06 | a priori threshold for statistical significance <0.05 | Mean Difference (Final Values) | 1.3 | 2-Sided | 95 | -0.1 | 2.6 | Other |
| Test meal 2 (HGLP meal) |
|
|
| Test meal 3 (MGL meal) |
|
|
| Control meal |
|
|
| Linear Mixed Model |
| 0.06 |
a priori threshold for statistical significance <0.05 |
| Mean Difference (Final Values) |
| -1.2 |
| 2-Sided |
| 95 |
| -2.4 |
| 0.04 |
| Other |
| MGL meals vs control meals | Linear Mixed Model | 0.90 | a priori threshold for statistical significance <0.05 | Mean Difference (Final Values) | -0.08 | 2-Sided | 95 | -1.3 | 1.2 | Other |
| HGL meals vs HGLP meals | Linear Mixed Model | 0.05 | a priori threshold for statistical significance <0.05 Adjusted with Bonferroni correction | Mean Difference (Final Values) | 1.4 | 2-Sided | 95 | 0.3 | 2.5 | Other |
| HGL meals vs MGL meals | Linear Mixed Model | 0.55 | a priori threshold for statistical significance <0.05 | Mean Difference (Final Values) | 0.34 | 2-Sided | 95 | -0.8 | 1.5 | Other |
| MGL meals vs HGLP meals | Linear Mixed Model | 0.08 | a priori threshold for statistical significance <0.05 | Mean Difference (Final Values) | 1.1 | 2-Sided | 95 | -0.1 | 2.2 | Other |