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Completed

NCT Number: NCT01706653

The Effects of a Polyphenol-enriched Fruit Drink on Metabolic Health

The purpose of this study is to determine whether consumption of the active product affects postprandial changes in metabolic indices, in comparison to the control product.

Completed

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes & Nutritional Sciences Division, School of Medicine, King's College London

London, SE1 9NH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy free-living men aged from 20 to 60 years old, and postmenopausal women aged from 45 to 60 years old, on the day of inclusion
  • 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 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
  • 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.

Treatment and study plan

Polyphenol-enriched fruit-based drink - low

Dietary Supplement

Polyphenol-enriched fruit-based drink - medium

Dietary Supplement

Polyphenol-enriched fruit-based drink - high

Dietary Supplement

Very low polyphenol fruit based drink (control)

Dietary Supplement

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Lucozade Ribena Suntory

Registry information

Official study title

Fruit Polyphenols: Maximising Knowledge of Their Metabolic Health Benefits and Practical Applications

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 15, 2012
Registry last updated
Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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