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| Name | Class |
|---|---|
| DIANA Food | INDUSTRY |
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Postprandial hyperglycaemia can lead to adverse modifications to functional proteins within the body and eventually lead to the development of type 2 diabetes. Previous research by this group has shown that an apple polyphenol extract reduced hyperglycaemia following a high-carbohydrate meal. The aim of this study is to investigate the effects of lower doses of the apple extract on postprandial glycaemia, insulinaemia and plasma gastric inhibitory polypeptide concentrations following a mixed carbohydrate test meal.
Introduction:
Sharp peaks in blood glucose levels can lead to adverse modifications to functional proteins, oxidative stress and pancreatic beta cell dysfunction. It is therefore desirable to consume a diet that will allow more gradual rises in blood glucose levels after meals. Fruit polyphenols may help to limit the glucose excursion following a high carbohydrate meal. Previous research by this research group has demonstrated that 1200 mg of apple polyphenols (Appl'Inâ„¢) inhibited the average incremental area under the curve (T+0 to T+30 min) of plasma glucose by 54% relative to placebo. Possible mechanisms include inhibition of intestinal enzymes and inhibition of intestinal glucose absorption by decreasing SGLT1/GLUT2 transport activity. The literature also suggests that foods rich in polyphenols exert beneficial effects on risk factors of cardiovascular disease such as hypertension, lipid metabolism and vascular function.
Study design:
A randomised, controlled, double-blind, cross-over study will be conducted. Four matched test drinks will be consumed in random order on separate study visits immediately before a mixed-carbohydrate test meal, containing either: 1) 1.2 g, 2) 0.9 g 3). 0.6 g of apple polyphenols, or 4). placebo. Postprandial changes in plasma glucose, insulin, NEFA, GIP, GLP-1 concentrations as well as changes in vascular function will be measured. Twenty-four hour urine samples will be collected for analysis of urinary polyphenol metabolites and glucose. In a sub sample of participants, a paracetamol absorption test will be incorporated via addition of 1.5 g paracetamol into the test drink.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.2 g apple polyphenols | Experimental | 1200 mg apple polyphenols delivered in a low sugar drink. |
|
| 0.9 g apple polyphenols | Experimental | 900 mg apple polyphenols delivered in a low sugar drink. |
|
| 0.6 g apple polyphenols | Experimental | 600 mg apple polyphenols delivered in a low sugar drink. |
|
| Placebo | Placebo Comparator | No polyphenols delivered in a low sugar drink. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apple polyphenols | Dietary Supplement | Drinks will be delivered in random order at 4 separate study visits immediately before a high-carbohydrate meal. Seven days wash-out period will be required between study days. |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial Glycaemia | Primary outcome: Area over baseline t+0-30 min for plasma glucose | 30 min following the test drink |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial Insulinaemia | Peak postprandial insulin concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min. | baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink |
| Postprandial Glucose-dependent Insulinotropic Polypeptide (GIP) Concentrations |
| Measure | Description | Time Frame |
|---|---|---|
| 7-day Food Diary | Habitual dietary intake analysis | Baseline |
| Women's Health Questionnaire | Questionnaire to identify menstrual phase | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metabolic Research Unit at King's College London | Waterloo Campus | London | SE1 9NH | United Kingdom |
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34 out of 64 screened were randomized. Of those not randomized, 8 did not meet inclusion criteria, 1 had a minor adverse event, and 21 declined to participate.
Healthy participants were recruited from King's College London (KCL) and the general public in London and surrounding counties.
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| ID | Title | Description |
|---|---|---|
| FG000 | Doses of Apple Extract | Randomised sequences of singled doses of 0, 0.9, 1.2 and 1.8 g apple extract consumed with a test meal. Participants first received intervention 1 on the morning of a study visit, followed by a washout period of at least 7 days, then intervention 2 followed by a 7 day washout period, then intervention 3 followed by a 7 day washout period, then intervention 4. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants completing all study interventions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean (SD) age (years) | Numbers analyzed in rows differ from overall as they are given for men, postmenopausal women, and premenopausal women separately. |
| 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 | Postprandial Glycaemia | Primary outcome: Area over baseline t+0-30 min for plasma glucose | Posted | Mean | Standard Error | mmol/L*min | 30 min following the test drink |
|
5 hour study visit for each of the 4 interventions.
Arms/groups for randomised sequence are combined as there are a large number of different sequences.
All-Cause Mortality was not monitored/assessed.
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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 | 1.8 g Apple Extract | High dose of polyphenol apple extract in a drink | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Wendy Hall | King's College London | 020 7836 5454 | wendy.hall@kcl.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 | Sep 30, 2016 | Feb 5, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 25, 2017 | Feb 25, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Dietary Supplement |
|
Peak postprandial GIP concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min. |
| baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink |
| Postprandial Glucagon-like Peptide-1 (GLP-1) Concentrations | Peak postprandial GLP-1 concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min. | baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink |
| Postprandial C-peptide Concentrations | Peak postprandial C-peptide concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min. | baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink |
| Postprandial Non-esterified Fatty Acid (NEFA) Concentrations | Peak postprandial NEFA concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min | baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink |
| Postprandial Triglyceride (TAG) Concentrations | Peak postprandial TAG concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min. | baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink |
| Postprandial Paracetamol Concentrations | Peak postprandial paracetamol concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min (1.5 g paracetamol will be added to all test drinks in a sub-group of participants). | baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink |
| Postprandial Polyphenol Metabolite Concentrations | Peak postprandial polyphenol metabolites concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min. | baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink |
| Vascular Endothelial Function by Flow-mediated Dilation (FMD) | Change in FMD after the consumption of test drink. | baseline and 120, 240, 300 min following the test drink |
| Vascular Function (Arteriograph Measurement) | Change in augmentation index following the test drink. | Baseline and 60, 90, 120, 180, 240 min following the test drink |
| Blood Pressure | Change in blood pressure following the test drink. | Baseline and 60, 90, 120, 180, 240 min following the test drink |
| Urinary Polyphenol Metabolites | Change in urinary polyphenol metabolite concentration following the test drink. | 0-4 h, 4-8 h, 8-24 h following the test drink |
| Urinary Glucose | Change in urinary glucose concentration following the test drink. | 0-4 h, 4-8 h, 8-24 h following the test drink |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fasting glucose | Fasting plasma glucose concentrations (mmol/L) | Mean | Standard Deviation | mmol/L |
|
| OG003 | 0 g Apple Extract | Control in a drink matched for appearance and macronutrients |
|
|
| Secondary | Postprandial Insulinaemia | Peak postprandial insulin concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min. | Not Posted | baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink | Participants |
| Secondary | Postprandial Glucose-dependent Insulinotropic Polypeptide (GIP) Concentrations | Peak postprandial GIP concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min. | Not Posted | baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink | Participants |
| Secondary | Postprandial Glucagon-like Peptide-1 (GLP-1) Concentrations | Peak postprandial GLP-1 concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min. | Not Posted | baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink | Participants |
| Secondary | Postprandial C-peptide Concentrations | Peak postprandial C-peptide concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min. | Not Posted | baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink | Participants |
| Secondary | Postprandial Non-esterified Fatty Acid (NEFA) Concentrations | Peak postprandial NEFA concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min | Not Posted | baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink | Participants |
| Secondary | Postprandial Triglyceride (TAG) Concentrations | Peak postprandial TAG concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min. | Not Posted | baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink | Participants |
| Secondary | Postprandial Paracetamol Concentrations | Peak postprandial paracetamol concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min (1.5 g paracetamol will be added to all test drinks in a sub-group of participants). | Not Posted | baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink | Participants |
| Secondary | Postprandial Polyphenol Metabolite Concentrations | Peak postprandial polyphenol metabolites concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min. | Not Posted | baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink | Participants |
| Secondary | Vascular Endothelial Function by Flow-mediated Dilation (FMD) | Change in FMD after the consumption of test drink. | Not Posted | baseline and 120, 240, 300 min following the test drink | Participants |
| Secondary | Vascular Function (Arteriograph Measurement) | Change in augmentation index following the test drink. | Not Posted | Baseline and 60, 90, 120, 180, 240 min following the test drink | Participants |
| Secondary | Blood Pressure | Change in blood pressure following the test drink. | Not Posted | Baseline and 60, 90, 120, 180, 240 min following the test drink | Participants |
| Secondary | Urinary Polyphenol Metabolites | Change in urinary polyphenol metabolite concentration following the test drink. | Not Posted | 0-4 h, 4-8 h, 8-24 h following the test drink | Participants |
| Secondary | Urinary Glucose | Change in urinary glucose concentration following the test drink. | Not Posted | 0-4 h, 4-8 h, 8-24 h following the test drink | Participants |
| Other Pre-specified | 7-day Food Diary | Habitual dietary intake analysis | Not Posted | Baseline | Participants |
| Other Pre-specified | Women's Health Questionnaire | Questionnaire to identify menstrual phase | Not Posted | Baseline | Participants |
| 0 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | 1.2 g Apple Extract | Medium dose of polyphenol apple extract in a drink | 0 | 0 | 0 | 34 | 0 | 34 |
| EG002 | 0.9 g Apple Extract | Low dose of apple extract in a drink | 0 | 0 | 0 | 34 | 0 | 34 |
| EG003 | 0 g Apple Extract | Control in a drink matched for appearance and macronutrients | 0 | 0 | 0 | 34 | 0 | 34 |
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