Acute Effects of Blackcurrant and Citrus Polyphenol Extracts on Postprandial Glycaemia
NCT ID: NCT03184064
Last Updated: 2018-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2017-05-30
2018-06-01
Brief Summary
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Detailed Description
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The aim of this study is to investigate the effects of blackcurrant polyphenol extracts and citrus polyphenol extracts (and their combination), on postprandial glycaemia, insulinaemia and gastrointestinal hormone concentrations following a mixed carbohydrate test meal. It is hypothesised that blackcurrant and citrus extracts alone will inhibit glycaemia compared to placebo, a combination of the two will have a greater effect.
Study design: A randomised, controlled, double-blind, cross-over study will be conducted. Subjects will consume different drinks at 4 separate study visits. Drinks will contain either: blackcurrant extract (low dose), blackcurrant extract (high dose), citrus extract (low dose), blackcurrant and citrus extract (low dose + low dose), or placebo (no polyphenols). The study will utilise an incomplete block design. Subjects will consume the placebo drink and 3 out of 4 of the polyphenol-containing drinks during the study. At least a 7-day wash-out period will be required between study days. Baseline (fasted) blood samples will be taken in duplicate at T-10 min and T-5 min before consuming the test drink (T+0 min). Immediately following consumption of the drink, a mixed carbohydrate test meal will be consumed. Further blood samples will be collected at 10 min intervals for the first 30 min and then every 15 min until T+90 min and at T+120 min. Blood samples will be analysed for plasma glucose, insulin, glucose-dependent insulinotropic peptide (GIP), glucagon-like peptide 1 (GLP-1), peptide YY (PYY), C-peptide and nonesterified fatty acids (NEFA).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Treatment arm 1
Participants will receive the placebo, blackcurrant extract (low dose), blackcurrant extract (high dose), citrus extract (low dose) at 4 separate study visits, in a random order. Visits will be separated by at least 7 days.
Blackcurrant extract (low dose)
Participants will consume a small beverage that contains blackcurrant extract (low dose) immediately before a high-carbohydrate meal.
Placebo
Participants will consume a small beverage that contains no fruit extracts immediately before a high-carbohydrate meal.
Citrus extract (low dose)
Participants will consume a small beverage that contains citrus extract (low dose) immediately before a high-carbohydrate meal.
Blackcurrant extract (high dose)
Participants will consume a small beverage that contains blackcurrant extract (high dose) immediately before a high-carbohydrate meal.
Treatment arm 2
Participants will receive the placebo, citrus extract (low dose), blackcurrant extract (high dose), blackcurrant and citrus extracts (low dose / low dose) at 4 separate study visits, in a random order. Visits will be separated by at least 7 days.
Placebo
Participants will consume a small beverage that contains no fruit extracts immediately before a high-carbohydrate meal.
Citrus extract (low dose)
Participants will consume a small beverage that contains citrus extract (low dose) immediately before a high-carbohydrate meal.
Blackcurrant extract (high dose)
Participants will consume a small beverage that contains blackcurrant extract (high dose) immediately before a high-carbohydrate meal.
Blackcurrant and citrus extracts (low dose / low dose)
Participants will consume a small beverage that contains blackcurrant and citrus extracts (low dose / low dose)immediately before a high-carbohydrate meal.
Treatment arm 3
Participants will receive the placebo, blackcurrant extract (low dose), blackcurrant extract (high dose), blackcurrant and citrus extracts (low dose / low dose) at 4 separate study visits, in a random order. Visits will be separated by at least 7 days.
Blackcurrant extract (low dose)
Participants will consume a small beverage that contains blackcurrant extract (low dose) immediately before a high-carbohydrate meal.
Placebo
Participants will consume a small beverage that contains no fruit extracts immediately before a high-carbohydrate meal.
Blackcurrant extract (high dose)
Participants will consume a small beverage that contains blackcurrant extract (high dose) immediately before a high-carbohydrate meal.
Blackcurrant and citrus extracts (low dose / low dose)
Participants will consume a small beverage that contains blackcurrant and citrus extracts (low dose / low dose)immediately before a high-carbohydrate meal.
Treatment arm 4
Participants will receive the placebo, blackcurrant extract (low dose), citrus extract (low dose), blackcurrant and citrus extracts (low dose / low dose) at 4 separate study visits, in a random order. Visits will be separated by at least 7 days.
Blackcurrant extract (low dose)
Participants will consume a small beverage that contains blackcurrant extract (low dose) immediately before a high-carbohydrate meal.
Placebo
Participants will consume a small beverage that contains no fruit extracts immediately before a high-carbohydrate meal.
Citrus extract (low dose)
Participants will consume a small beverage that contains citrus extract (low dose) immediately before a high-carbohydrate meal.
Blackcurrant and citrus extracts (low dose / low dose)
Participants will consume a small beverage that contains blackcurrant and citrus extracts (low dose / low dose)immediately before a high-carbohydrate meal.
Interventions
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Blackcurrant extract (low dose)
Participants will consume a small beverage that contains blackcurrant extract (low dose) immediately before a high-carbohydrate meal.
Placebo
Participants will consume a small beverage that contains no fruit extracts immediately before a high-carbohydrate meal.
Citrus extract (low dose)
Participants will consume a small beverage that contains citrus extract (low dose) immediately before a high-carbohydrate meal.
Blackcurrant extract (high dose)
Participants will consume a small beverage that contains blackcurrant extract (high dose) immediately before a high-carbohydrate meal.
Blackcurrant and citrus extracts (low dose / low dose)
Participants will consume a small beverage that contains blackcurrant and citrus extracts (low dose / low dose)immediately before a high-carbohydrate meal.
Eligibility Criteria
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Inclusion Criteria
* Men and women
Exclusion Criteria
* Able to understand the information sheet and willing to comply with study protocol
* Able to give informed written consent
* 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 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
* 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.
18 Years
70 Years
ALL
Yes
Sponsors
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King's College London
OTHER
Lucozade Ribena Suntory
INDUSTRY
Responsible Party
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Principal Investigators
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Wendy L Hall, PhD
Role: PRINCIPAL_INVESTIGATOR
King's College London
Locations
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Metabolic Research Unit
London, England, United Kingdom
Countries
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References
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Castro-Acosta ML, Smith L, Miller RJ, McCarthy DI, Farrimond JA, Hall WL. Drinks containing anthocyanin-rich blackcurrant extract decrease postprandial blood glucose, insulin and incretin concentrations. J Nutr Biochem. 2016 Dec;38:154-161. doi: 10.1016/j.jnutbio.2016.09.002. Epub 2016 Sep 14.
Pinto AM, Hobden MR, Brown KD, Farrimond J, Targett D, Corpe CP, Ellis PR, Todorova Y, Socha K, Bahsoon S, Haworth C, Marcel M, Nie X, Hall WL. Acute effects of drinks containing blackcurrant and citrus (poly)phenols and dietary fibre on postprandial glycaemia, gut hormones, cognitive function and appetite in healthy adults: two randomised controlled trials. Food Funct. 2023 Nov 13;14(22):10163-10176. doi: 10.1039/d3fo03085g.
Other Identifiers
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HVS-007
Identifier Type: -
Identifier Source: org_study_id
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