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: May 14, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fruit Polyphenols: Maximising Knowledge of Their Metabolic Health Benefits and Practical Applications

Further study details as provided by King's College London:

Enrollment: 23
Study Start Date: October 2012
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention 1
Polyphenol-enriched fruit-based drink - low
Dietary Supplement: Polyphenol-enriched fruit-based drink - low
Active Comparator: Intervention 2
Polyphenol-enriched fruit-based drink - medium
Dietary Supplement: Polyphenol-enriched fruit-based drink - medium
Active Comparator: Intervention 3
Polyphenol-enriched fruit-based drink - high
Dietary Supplement: Polyphenol-enriched fruit-based drink - high
Placebo Comparator: Intervention 4
Very low polyphenol fruit based drink (control)
Dietary Supplement: Very low polyphenol fruit based drink (control)

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706653

Locations
United Kingdom
Diabetes & Nutritional Sciences Division, School of Medicine, King's College London
London, United Kingdom, SE1 9NH
Sponsors and Collaborators
King's College London
GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Dr Wendy Hall, Lecturer in Nutritional Sciences, King's College London
ClinicalTrials.gov Identifier: NCT01706653     History of Changes
Other Study ID Numbers: TSB101118, 12681-83204
Study First Received: October 10, 2012
Last Updated: May 14, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by King's College London:
Polyphenol
Fruit
Metabolic
Healthy

ClinicalTrials.gov processed this record on August 28, 2014