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.

Study Overview

• Status: Completed
• Conditions: Healthy Men and Women
• Intervention / Treatment: 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
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9NH
    • Diabetes & Nutritional Sciences Division, School of Medicine, King's College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Lucozade Ribena Suntory

Publications and helpful links

General Publications

• 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.

Helpful Links

• Primary publication

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: October 10, 2012
• First Submitted That Met QC Criteria: October 12, 2012
• First Posted (Estimate): October 15, 2012

Study Record Updates

• Last Update Posted (Actual): September 16, 2019
• Last Update Submitted That Met QC Criteria: September 12, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Healthy; Polyphenol; Fruit; Metabolic
• Other Study ID Numbers: TSB101118; 12681-83204 (Other Grant/Funding Number: Technology Strategy Board)