The Effects of a Polyphenol-enriched Fruit Drink on Metabolic Health
NCT ID: NCT01706653
Last Updated: 2019-09-16
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
23 participants
INTERVENTIONAL
2012-10-31
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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Intervention 1
Polyphenol-enriched fruit-based drink - low
Polyphenol-enriched fruit-based drink - low
Intervention 2
Polyphenol-enriched fruit-based drink - medium
Polyphenol-enriched fruit-based drink - medium
Intervention 3
Polyphenol-enriched fruit-based drink - high
Polyphenol-enriched fruit-based drink - high
Intervention 4
Very low polyphenol fruit based drink (control)
Very low polyphenol fruit based drink (control)
Interventions
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Polyphenol-enriched fruit-based drink - low
Polyphenol-enriched fruit-based drink - medium
Polyphenol-enriched fruit-based drink - high
Very low polyphenol fruit based drink (control)
Eligibility Criteria
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Inclusion Criteria
* Able to understand the information sheet and comply with all the trial procedures
* Having given written consent to take part in the study prior to participation.
* Body mass index (BMI): 18.0 - 35 kg/m².
Exclusion Criteria
* 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
* 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
* Weight loss \>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 such as alpha-glucosidase inhibitors (e.g. acarbose), insulin-sensitising drugs (e.g. metformin, thiazolidinediones), sulfonylureas, and lipid-lowering drugs. Other medications, should be reviewed by medical representative from KCL on a case by case basis.
* Nutritional supplements that may interfere with the study such as higher dose vitamins/minerals (\>200% RNI), 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.
20 Years
60 Years
ALL
Yes
Sponsors
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Lucozade Ribena Suntory
INDUSTRY
King's College London
OTHER
Responsible Party
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Dr Wendy Hall
Lecturer in Nutritional Sciences
Locations
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Diabetes & Nutritional Sciences Division, School of Medicine, King's College London
London, , 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.
Related Links
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Primary publication
Other Identifiers
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12681-83204
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
TSB101118
Identifier Type: -
Identifier Source: org_study_id
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