- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03572296
Effect of Drinks Containing Fruit Polyphenol Extracts and Fibre on Postprandial Glycaemia. (Glu-MIX)
Effect of Drinks Containing Fruit Polyphenol Extracts and Fibre on Postprandial Glycaemia. The Glu-MIX Study
Postprandial glycaemia refers to the transient rise in blood glucose levels that occurs after consuming a meal. Large fluctuations in blood glucose levels, experienced on a frequent basis, may impair the functioning of pancreatic beta cells, and thus elevate the risk of developing type 2 diabetes mellitus (T2DM) and cardiovascular disease. Our group has previously shown that consuming a drink containing fruit polyphenols immediately before a meal, may reduce postprandial glycaemia. Importantly, other fruit components, namely soluble fibres, also impact on carbohydrate digestion by slowing gastric emptying rates. Combining fruit polyphenols and fibre in a drink may, potentially, have additive or synergistic effects on reducing postprandial glycaemia.
This study will investigate the effects of drinks containing blackcurrant polyphenol extract combined with pulp (source of fibre), and pulp alone, on postprandial outcomes and cognitive function following a mixed carbohydrate (starch and sucrose) test meal.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Intake of carbohydrate-rich foods transiently increases blood glucose levels (known as postprandial glycaemia). Repeated, high, postprandial glucose responses are evidenced to impair pancreatic beta cell function, thus increasing the risk of developing type-2 diabetes mellitus and cardiovascular disease. Therefore, meals that elicit a reduced, or more gradual, rise in blood glucose levels are desirable.
Previous studies have shown that consuming a drink containing fruit polyphenols, such as those from blackcurrants (BC), immediately before a high carbohydrate meal, reduced the postprandial glycaemic response. Importantly, other fruit components, namely soluble fibres, also impact on carbohydrate digestion by slowing gastric emptying rates. It is not yet known the effect of combining fibre and polyphenols on postprandial glycaemia. Although limited, there is a growing body of evidence showing beneficial acute effects of polyphenols in cognitive function which is of great interest in many work and academic environments where fast cognitive enhancement is wanted to perform a task or an exam.
This study will investigate the effects of drinks containing BC polyphenol extract combined with pulp (source of fibre), and pulp alone, on postprandial outcomes and cognitive function following a mixed carbohydrate (starch and sucrose) test meal.
Study design: A randomised, controlled, double-blind, cross-over study, of the healthy adult UK population, will be conducted. All subjects will receive the placebo drink, pulp only drink and the pulp with polyphenol drink in a random order. Baseline (fasted) blood samples will be taken before consuming the test drink (T0 min). Immediately following consumption of the drink, a mixed carbohydrate test meal will be consumed. Further blood samples will be collected at regular times until T150 min. Blood samples will be analysed for plasma glucose, insulin, glucose-dependent insulinotropic peptide (GIP) and C-peptide. Subjects will also perform a 30 min computer based cognitive performance test at baseline (T-45 min) and endpoint (T165 min). Visual analogue scales will be used to assess the effect of the test drinks on a range of sensory characteristics e.g. palatability, satiety and subjective mood feelings. Finally, an ad libitum pasta meal at the end of the study visit (T 215 min) will be used to assess the effects on energy intake.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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London, United Kingdom, SE1 9NH
- Metabolic Research Unit
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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 years
- Men and women
- 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 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 breastfeeding
- 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/ high fibre foods for 48 h before the study
- Weight change >3 kg in preceding 2 months
- 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). 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
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
No polyphenols or fibre will be delivered in a low sugar drink.
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Drinks will be delivered in random order at 3 separate study visits immediately before a high carbohydrate meal.
A minimum of 4 days (ideally 7 days) wash-out period will be required between study days.
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EXPERIMENTAL: Polyphenol and fibre
Blackcurrant extract (800 mg total polyphenols) and pulp (source of fibre) will be delivered in a low sugar drink.
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Drinks will be delivered in random order at 3 separate study visits immediately before a high carbohydrate meal.
A minimum of 4 days (ideally 7 days) wash-out period will be required between study days.
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EXPERIMENTAL: Fibre
Pulp (source of fibre) will be delivered in a low sugar drink.
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Drinks will be delivered in random order at 3 separate study visits immediately before a high carbohydrate meal.
A minimum of 4 days (ideally 7 days) wash-out period will be required between study days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial glycaemia (iAUC 0-30 min)
Time Frame: 30 min
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The primary endpoint is iAUC 0-30 min for plasma glucose concentrations
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30 min
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial glycaemia: iAUC 0-120 min
Time Frame: 120 min
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iAUC 0-120 min for plasma glucose concentrations
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120 min
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Postprandial insulinemia: iAUC 0-30 min
Time Frame: 30 min
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iAUC 0-30 min for serum insulin concentrations
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30 min
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Postprandial insulinemia: iAUC 0-120 min
Time Frame: 120 min
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iAUC 0-120 min for serum insulin concentrations
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120 min
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Postprandial C-peptide: iAUC 0-30 min
Time Frame: 30 min
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iAUC 0-30 min for plasma C-peptide concentrations
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30 min
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Postprandial blood glucose-dependent insulinotropic peptide (GIP): iAUC 0-30 min
Time Frame: 30 min
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iAUC 0-30 min for plasma GIP concentrations
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30 min
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Postprandial blood glucose-dependent insulinotropic peptide (GIP): iAUC 0-120 min
Time Frame: 120 min
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iAUC 0-120 min for plasma GIP concentrations
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120 min
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Postprandial glycaemia: iAUC 0-150 min
Time Frame: 150 min
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iAUC 0-150 min for plasma glucose concentrations
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150 min
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Postprandial glycaemia: iCmax
Time Frame: 150 min
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iCmax for plasma glucose concentrations
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150 min
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Postprandial glycaemia: Tmax
Time Frame: 150 min
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Tmax for plasma glucose concentrations
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150 min
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Postprandial glycaemia: absolute concentrations at specific time points
Time Frame: 150 min
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Absolute concentrations at specific time points, for plasma glucose concentrations
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150 min
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Postprandial insulinemia: iAUC 0-150 min
Time Frame: 150 min
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iAUC 0-150 min for serum insulin concentrations
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150 min
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Postprandial insulinemia: iCmax
Time Frame: 150 min
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iCmax, for serum insulin concentrations
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150 min
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Postprandial insulinemia: Tmax
Time Frame: 150 min
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Tmax for serum insulin concentrations
|
150 min
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Postprandial insulinemia: absolute concentrations at specific time points
Time Frame: 150 min
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Absolute concentrations at specific time points, for serum insulin concentrations
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150 min
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Postprandial C-peptide: iAUC 0-120 min
Time Frame: 120 min
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iAUC 0-120 min for plasma C-peptide concentrations
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120 min
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Postprandial C-peptide: iAUC 0-150 min
Time Frame: 150 min
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iAUC 0-150 min for plasma C-peptide concentrations
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150 min
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Postprandial C-peptide: iCmax
Time Frame: 150 min
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iCmax for plasma C-peptide concentrations
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150 min
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Postprandial C-peptide: Tmax
Time Frame: 150 min
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Tmax for plasma C-peptide concentrations
|
150 min
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Postprandial C-peptide: Absolute concentrations at specific time points
Time Frame: 150 min
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Absolute concentrations at specific time points, for plasma C-peptide concentrations
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150 min
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Postprandial blood glucose-dependent insulinotropic peptide (GIP): iAUC 0-150 min
Time Frame: 150 min
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iAUC 0-150 min for plasma GIP concentrations
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150 min
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Postprandial blood glucose-dependent insulinotropic peptide (GIP): iCmax
Time Frame: 150 min
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iCmax, for plasma GIP concentrations
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150 min
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Postprandial blood glucose-dependent insulinotropic peptide (GIP): Tmax
Time Frame: 150 min
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Tmax for plasma GIP concentrations
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150 min
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Postprandial blood glucose-dependent insulinotropic peptide (GIP): Absolute concentrations at specific time points
Time Frame: 150 min
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Absolute concentrations at specific time points, for plasma GIP concentrations
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150 min
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Cognitive function test scores
Time Frame: Before and after 150 min blood collection
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Descriptive statistics
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Before and after 150 min blood collection
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
7-d food diary (estimated/unweighed)
Time Frame: 7-days
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Habitual dietary intake analysis
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7-days
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100 mm visual analogue scale (VAS) measures of the palatability of the study drink
Time Frame: 10 min following the test drink
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For each VAS, a numerical score between 0 (not at all) and 100 (extremely) mm was obtained.
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10 min following the test drink
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100 mm visual analogue scale (VAS) measures of mood, satiety and digestive comfort
Time Frame: 150 min
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For each VAS, a numerical score between 0 (not at all) and 100 (extremely) mm was obtained.
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150 min
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Ad libitum energy intake
Time Frame: 15 min
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Energy intake during ad libitum meal
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15 min
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100 mm visual analogue scale (VAS) measures of the palatability of the ad libitum meal
Time Frame: 15 min following the ad libitum meal
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For each VAS, a numerical score between 0 (not at all) and 100 (extremely) mm was obtained.
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15 min following the ad libitum meal
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Buccal mouth swab
Time Frame: One off sample, collected at the first 1 day of study visit
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Future exploratory analysis of lactase activity via the derived allele at the European
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One off sample, collected at the first 1 day of study visit
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HVS-010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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