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| Name | Class |
|---|---|
| Imperial College London | OTHER |
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The goal of this clinical trial is to determine whether the sequence of macronutrient consumption affects post-prandial glycaemia in women with gestational diabetes mellitus.
The main questions it aims to answer are:
Participants will attend two study visits at the Centre for Public Health, with an interval of at least two days between the visits and complete the following, anthropometric measurements, demographic and appetite questionnaires, glucose measurements, two food diaries and fasting blood samples and the consumption of the study breakfast. Participants will be asked to eat either the protein/fat-based component of the meal (scrambled egg) before or after the carbohydrate-based component (wholemeal toast) on their first visit and on the other visit they will be asked to eat the meal in the reverse order. The order in which this occurs will be randomised and each participant will act as their own control. Researchers will compare the results from participants between the two test meals to see if the order of macronutrient consumption has any effect on post-prandial glycaemia, gut hormones, satiety scores and energy and macronutrient intake.
Gestational diabetes mellitus (GDM) is glucose intolerance with onset or first diagnosis during pregnancy, affecting around 1 in 10 pregnancies in the United Kingdom (UK). Women with GDM are 10 times more likely to develop type 2 DM and twice as likely to develop cardiovascular disease in later life than women without GDM. Dietary modification is recommended as first line management to optimise blood glucose control. However, this often fails, necessitating the use of medication such as metformin and insulin. There is a pressing need to find safe and effective dietary approaches to optimise glycaemic control in GDM which can be easily adhered to in order to improve longer-term outcomes. The impact of the sequence of macronutrients on glycaemic control is an emerging area of interest. Recent evidence suggests that the consumption of the fat/protein components of a meal prior to the carbohydrate components, reduces the peak by around 40% after food. This study aims to determine whether the order that macronutrients (i.e. protein, fat, carbohydrate) are eaten affects; blood sugar glucose levels in the blood after a meal, appetite, food intake and the release of hormones in the body, in women with GDM.
Pregnant women with GDM, aged 18-50 years old are eligible for the study. Women are not eligible if they have a history of type 1 or 2 diabetes, any clinically confirmed food allergies, taking medication for GDM, severe nausea or using anti-sickness medication.
Recruitment will be via antenatal clinics in the South-Eastern Health and Social Care Trust (SEHSCT). Participants will attend the Centre for Public Health on two occasions (maximum 2 weeks between visits) and will involve the collection of demographic information, weight and height measurements, blood samples, glucose measurements, consumption of study breakfast, and completion of two 1-day food diaries.
Participants will be asked to eat either the protein/fat-based component of the meal (scrambled egg) before or after the carbohydrate-based component (wholemeal toast) on their first visit and on the other visit they will be asked to eat the meal in the reverse order. The order in which this occurs will be randomised and each participant will act as their own control. Scrambled egg was chosen as the protein and fat will be homogenously distributed (compared to boiled egg, for example). Wholemeal toast was chosen as, although lower glycaemic index and therefore less likely to expeditiously raise blood glucose than toasted white bread, it will be more consistent with the participants' existing dietary needs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visit 1: Protein/fat then carbohydrate. Visit 2: Carbohydrate then protein/fat. | Experimental | Participants who are randomised to eat the protein/fat-based component (scrambled egg) of the meal before the carbohydrate-based component (wholemeal toast) on their first study visit and on their second study visit they will be asked to eat the meal in the reverse order. The order in which this occurs will be randomised and each participant will act as their own control. |
|
| Visit 1: Carbohydrate then protein/fat. Visit 2: Protein/fat then carbohydrate." | Experimental | Participants who are randomised to eat the carbohydrate-based component (wholemeal toast) of the meal before the protein/fat-based component (scrambled egg) on their first study visit and on their second study visit they will be asked to eat the meal in the reverse order. The order in which this occurs will be randomised and each participant will act as their own control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visit 1: Protein/fat then carbohydrate. Visit 2: Carbohydrate then protein/fat. | Other | Participants who are randomised to eat the protein/fat-based component (scrambled egg) of the meal before the carbohydrate-based component (wholemeal toast) on their first study visit, will be asked to eat the meal in the reverse order at their second study visit. Meals will be prepared by members of the research team who have completed Food Safety training. Participants will be asked to consume a 440kcal breakfast meal within 10 minutes, approximately 1.5 hours after arrival at their first study visit and approximately 30 minutes after arrival at their second study visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial Glucose | The difference in the magnitude of postprandial rise in blood glucose between the two test meals. | Difference between Visit 1 [time 0 and 125 minutes] and Visit 2 [time 0 and 125 minutes] |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin | The difference in the magnitude of postprandial change in serum levels of insulin between the two test meals. | Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes] |
| C-Peptide |
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Inclusion Criteria:
Exclusion Criteria:
Participants can be recruited onto the study if they have previously had GDM in another pregnancy. Participants can also be recruited if they are involved in other research studies, but this will depend on the study type and the decision will be made by the Chief/Principal Investigator.
Participants must be pregnant with GDM to take part in the study, and therefore must be female.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannah O'Hara, MBBS BSc PhD DFSRH MRCGP | Contact | +44 (0) 28 9097 6350 | h.ohara@qub.ac.uk | |
| Danielle Logan, PhD | Contact | +44 (0) 28 9097 6350 | d.logan@qub.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Hannah O'Hara, MBBS BSc PhD DFSRH MRCGP | Queen's University, Belfast | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Public Health, Institute of Clinical Sciences A | Recruiting | Belfast | BT12 6BA | United Kingdom |
The researchers are happy to share results from the study for the purposes of a meta-analysis. This will be completed on approach to the researchers.
Data should be available from December 2025 and will be available for 2 years.
Use of results in a meta-analysis will be available by contacting the research team.
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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 | Feb 11, 2025 |
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This will be a randomised crossover study. Participants will be asked to eat either the protein/fat-based component of the meal (scrambled egg) before or after the carbohydrate-based component (wholemeal toast) on their first visit and on the other visit they will be asked to eat the meal in the reverse order. The order in which this occurs will be randomised and each participant will act as their own control.
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It is not possible to blind participants or researchers in this study due to the nature of the nutritional intervention. However, the allocation to each group will be blinded using envelopes.
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| Visit 1: Carbohydrate then protein/fat. Visit 2: Protein/fat then carbohydrate. | Other | Participants who are randomised to eat the carbohydrate-based component (wholemeal toast) of the meal before the protein/fat-based component (scrambled egg) on their first study visit, will be asked to eat the meal in the reverse order at their second study visit. Meals will be prepared by members of the research team who have completed Food Safety training. Participants will be asked to consume a 440kcal breakfast meal within 10 minutes, approximately 1.5 hours after arrival at their first study visit and approximately 30 minutes after arrival at their second study visit. |
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The difference in the magnitude of postprandial change in serum levels of c-peptide between the two test meals.
| Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes] |
| Total Ghrelin | The difference in the magnitude of postprandial change in serum levels of total ghrelin between the two test meals. | Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes] |
| Glucagon (GCG) | The difference in the magnitude of postprandial change in serum levels of GCG between the two test meals. | Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes] |
| Glucagon-like peptide-1 (GLP-1) | The difference in the magnitude of postprandial change in serum levels of GLP-1 between the two test meals. | Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes] |
| Peptide Tyrosine (PYY) | The difference in the magnitude of postprandial change in serum levels of PYY between the two test meals. | Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes] |
| Satiety Scores | The difference in mean change in pre-post ingestion satiety scores between the two test meals, using an appetite visual analogue scale (range 0 - 100) [The direction of the score will depend on the individual question]. | Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes] |
| Nutrient intake | The difference in 24 hour energy and macronutrient intake following the two test meals. | Difference between Visit 1 [time 0 and 24 hours] and Visit 2 [time 0 and 24 hours] |
| Mar 24, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 11, 2025 | Mar 4, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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