- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02940249
Effects of an Apple Extract on Glycaemia: The GLU-Pomme Study (GLU-Pomme)
Dose-response Effect of an Apple Extract on Postprandial Glycaemia: a Randomised Controlled Trial. The GLU-POMME Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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'In™) 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
London
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Waterloo Campus, London, United Kingdom, SE1 9NH
- Metabolic Research Unit at King's College London
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: 18-70 y
- Male and female
- Healthy (free of diagnosed diseases listed in the exclusion criteria)
- Body Mass Index 18-35 kg/m2
- Able to understand the information sheet and willing to comply with study protocol
- Able to give informed written consent
Exclusion Criteria:
- Those diagnosed with Phenylketonuria (PKU)
- Those with known or suspected food and/or paracetamol intolerances, allergies or hypersensitivity
- Women who are known to be pregnant or who are intending to become pregnant over the course of the study
- Women who are breast feeding
- Participation in another clinical trial
- Those who have donated blood within 3 months of the screening visit and participants for whom participation in this study would result in having donated more than 1500 millilitres of blood in the previous 12 months.
- Full Blood Counts and Liver Function test results outside of the normal range.
- Current smokers, or reported giving up smoking within the last 6 months
- History of substance abuse or alcoholism
- Reported history of Cardiovascular disease, diabetes (or fasting glucose ≥ 7.1 mmol/L), cancer, kidney, liver or bowel disease, gastrointestinal disorder or use of drug likely to alter gastrointestinal function
- Unwilling to restrict consumption of specified high polyphenol foods for 48 h before the study
- Weight change >3kg in preceding 2 months and body mass index <18 or >35 kg/m2
- Blood pressure ≥160/100 mmHg
- Total cholesterol ≥ 7.5 mmol/L; fasting triacylglycerol concentrations ≥ 5.0 mmol/L
- Medications that may interfere with the study: alpha-glucosidase inhibitors (acarbose: Glucobay), insulin sensitizing drugs (metformin: Glucophage, Glucophage SR, Eucreas, Janumet; thiazolidinediones: Actos, Competact), sulfonylureas (Daonil, Diamicron, Diamicron MR, Glibenese, Minodiab, Amaryl Tolbutamide), and lipid lowering drugs (statins, nicotinic acid, colestyramine anhydrous, ezetimibe, fibrates); and medications that may react unpredictably with paracetamol: ketoconazole, metoclopramide, carbamazepine, phenobarbital, phenytoin, primidone, warfarin and other products containing paracetamol. Other medications should be reviewed by medical representative from KCL on a case by case basis.
- Nutritional supplements that may interfere with the study: higher dose vitamins/minerals (>200% Recommend Nutrient Intake), B vitamins, Vitamin C, calcium, copper, chromium, iodine, iron, magnesium, manganese, phosphorus, potassium and zinc. Subjects already taking vitamin or minerals at a dose around 100% or less up to 200% of the RNI, or evening primrose/algal/fish oil supplements will be asked to maintain habitual intake patterns, ensuring that they take them every day and not sporadically. They will be advised not to stop taking supplements or start taking new supplements during the course of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1.2 g apple polyphenols
1200 mg apple polyphenols delivered in a low sugar drink.
|
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.
|
Experimental: 0.9 g apple polyphenols
900 mg apple polyphenols delivered in a low sugar drink.
|
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.
|
Experimental: 0.6 g apple polyphenols
600 mg apple polyphenols delivered in a low sugar drink.
|
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.
|
Placebo Comparator: Placebo
No polyphenols delivered in a low sugar drink.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial Glycaemia
Time Frame: 30 min following the test drink
|
Primary outcome: Area over baseline t+0-30 min for plasma glucose
|
30 min following the test drink
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial Insulinaemia
Time Frame: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
|
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
Time Frame: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
|
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
Time Frame: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
|
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
Time Frame: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
|
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
Time Frame: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
|
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
Time Frame: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
|
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
Time Frame: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
|
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
Time Frame: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
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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.
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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)
Time Frame: baseline and 120, 240, 300 min following the test drink
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Change in FMD after the consumption of test drink.
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baseline and 120, 240, 300 min following the test drink
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Vascular Function (Arteriograph Measurement)
Time Frame: Baseline and 60, 90, 120, 180, 240 min following the test drink
|
Change in augmentation index following the test drink.
|
Baseline and 60, 90, 120, 180, 240 min following the test drink
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Blood Pressure
Time Frame: Baseline and 60, 90, 120, 180, 240 min following the test drink
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Change in blood pressure following the test drink.
|
Baseline and 60, 90, 120, 180, 240 min following the test drink
|
Urinary Polyphenol Metabolites
Time Frame: 0-4 h, 4-8 h, 8-24 h following the test drink
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Change in urinary polyphenol metabolite concentration following the test drink.
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0-4 h, 4-8 h, 8-24 h following the test drink
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Urinary Glucose
Time Frame: 0-4 h, 4-8 h, 8-24 h following the test drink
|
Change in urinary glucose concentration following the test drink.
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0-4 h, 4-8 h, 8-24 h following the test drink
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
7-day Food Diary
Time Frame: Baseline
|
Habitual dietary intake analysis
|
Baseline
|
Women's Health Questionnaire
Time Frame: Baseline
|
Questionnaire to identify menstrual phase
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLU-Pomme
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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