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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Dr Wendy Hall, King's College London
ClinicalTrials.gov Identifier:
NCT01706653
First received: October 10, 2012
Last updated: April 8, 2013
Last verified: April 2013

October 10, 2012
April 8, 2013
October 2012
March 2013   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01706653 on ClinicalTrials.gov Archive Site
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The Effects of a Polyphenol-enriched Fruit Drink on Metabolic Health
Fruit Polyphenols: Maximising Knowledge of Their Metabolic Health Benefits and Practical Applications

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Healthy Men and Women
  • Dietary Supplement: 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)
  • Active Comparator: Intervention 1
    Polyphenol-enriched fruit-based drink - low
    Intervention: Dietary Supplement: Polyphenol-enriched fruit-based drink - low
  • Active Comparator: Intervention 2
    Polyphenol-enriched fruit-based drink - medium
    Intervention: Dietary Supplement: Polyphenol-enriched fruit-based drink - medium
  • Active Comparator: Intervention 3
    Polyphenol-enriched fruit-based drink - high
    Intervention: Dietary Supplement: Polyphenol-enriched fruit-based drink - high
  • Placebo Comparator: Intervention 4
    Very low polyphenol fruit based drink (control)
    Intervention: Dietary Supplement: Very low polyphenol fruit based drink (control)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
April 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
20 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01706653
TSB101118, 12681-83204
No
Dr Wendy Hall, King's College London
King's College London
GlaxoSmithKline
Not Provided
King's College London
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP