Effects of Fruit Extracts on Glycaemia: The GLU-FRU Study
GLU-FRU
The Acute Effects of Blackcurrant and Apple Extracts on Postprandial Glycaemia: a Randomised Controlled Trial. The GLU-FRU Study
1 other identifier
interventional
34
1 country
1
Brief Summary
Raised blood glucose levels can lead to adverse modifications to functional proteins within the body and eventually lead to the development of type 2 diabetes. Fruit polyphenols may help to control glycaemia following a carbohydrate meal or beverage. The aim of this study is to investigate the effects of blackcurrant (BC) and apple (A) extracts on postprandial glycaemia, insulinaemia and plasma gastric inhibitory polypeptide concentrations following a mixed carbohydrate test meal.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 13, 2015
CompletedFirst Posted
Study publicly available on registry
January 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedSeptember 16, 2019
September 1, 2019
6 months
January 13, 2015
September 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postprandial glycaemia
Peak postprandial plasma glucose concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-120 min
baseline and 10, 20, 30, 45, 60, 75, 90 and 120 min following the test drink.
Secondary Outcomes (7)
Postprandial insulinaemia
baseline and 10, 20, 30, 45, 60, 75, 90 and 120 min following the test drink.
Postprandial glucose-dependent insulinotropic polypeptide (GIP) concentrations
baseline and 10, 20, 30, 45, 60, 75, 90 and 120 min following the test drink.
Postprandial glucagon-like peptide-1 (GLP-1) concentrations
baseline and 10, 20, 30, 45, 60, 75, 90 and 120 min following the test drink.
Blood pressure
baseline and 60, 90 and 120 min following the test drink.
Vascular function (Digital Volume Pulse; DVP)
baseline and 60, 90 and 120 min following the test drink.
- +2 more secondary outcomes
Study Arms (3)
Blackcurrant &Apple
EXPERIMENTAL600 mg blackcurrant anthocyanins + 600 mg apple polyphenols delivered in a low sugar fruit drink
Apple
EXPERIMENTAL1200 mg apple polyphenols delivered in a low sugar fruit drink
Control drink
PLACEBO COMPARATORNo polyphenols delivered in a low sugar fruit drink
Interventions
Drinks will be delivered in random order at 3 separate study visits immediately before a high-carbohydrate meal. Seven days wash-out period will be required between study days.
Eligibility Criteria
You may qualify if:
- Age: 20-60 y
- Male and female (post-menopausal only)
You may not qualify if:
- BMI 18-35 kg/m2
- 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.
- Those with Full Blood Counts and Liver Function test results outside of the normal range (see table 1 below).
- Pre-menopausal women due to the potential influence of cyclical changes in reproductive hormones on insulin sensitivity
- Current smokers, or reported giving up smoking within the last 6 months
- History of substance abuse or alcoholism
- Reported history of CVD, 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 24 h before the study
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Metabolic Research Unit at King's College London. Franklin-Wilkins Buiding. Waterloo Campus
London, England, W3 7LR, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wendy L Hall, Dr
King's College London
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer in Nutritional Sciences
Study Record Dates
First Submitted
January 13, 2015
First Posted
January 16, 2015
Study Start
January 1, 2015
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
September 16, 2019
Record last verified: 2019-09