Acute Effects of Blackcurrant and Citrus Polyphenol Extracts on Postprandial Glycaemia

NCT03184064 | Completed

• 1 other identifier: HVS-007
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Large postprandial glucose responses are associated with increased risk of chronic diseases, including diabetes and cardiovascular disease. Our group have previously shown that fruit polyphenol extracts, when consumed immediately before a mixed carbohydrate meal, reduce postprandial glycaemia. The aim of this study is to investigate the effects of a blackcurrant polyphenol extract and citrus polyphenol extract (and their combination), on postprandial glycaemia, insulinaemia and gastrointestinal hormone concentrations following a mixed carbohydrate test meal. It is hypothesised that blackcurrant and citrus extracts alone will inhibit glycaemia compared to placebo, and a combination of the two will have a greater effect.

Conditions

Postprandial Period

Keywords

Blackcurrant; Citrus; Polyphenols; Glucose; Postprandial; Metabolism

Outcome Measures

Primary Outcomes (1)

• Postprandial glycaemia (iAUC 0-30 min)

  The primary endpoint is iAUC 0-30 min for plasma glucose concentrations

  30 min

Secondary Outcomes (34)

• Postprandial glycaemia: iAUC 0-120 min

  120 min

• Postprandial glycaemia: iCmax

  120 min

• Postprandial glycaemia: Tmax

  120 min

• Postprandial glycaemia: absolute concentrations at specific time points

  120 min

• Postprandial insulinemia: iAUC 0-30 min

  30 min

Other Outcomes (4)

• Food diary (estimated/unweighed)

  7-days, collected at screening

• VAS measures of the palatability of the study drink

  10 min following the test drink

• VAS measures of mood, satiety and digestive comfort

  120 min

Study Arms (4)

Treatment arm 1

EXPERIMENTAL

Participants will receive the placebo, blackcurrant extract (low dose), blackcurrant extract (high dose), citrus extract (low dose) at 4 separate study visits, in a random order. Visits will be separated by at least 7 days.

Dietary Supplement: Blackcurrant extract (low dose); Dietary Supplement: Placebo; Dietary Supplement: Citrus extract (low dose); Dietary Supplement: Blackcurrant extract (high dose)

Treatment arm 2

EXPERIMENTAL

Participants will receive the placebo, citrus extract (low dose), blackcurrant extract (high dose), blackcurrant and citrus extracts (low dose / low dose) at 4 separate study visits, in a random order. Visits will be separated by at least 7 days.

Dietary Supplement: Placebo; Dietary Supplement: Citrus extract (low dose); Dietary Supplement: Blackcurrant extract (high dose); Dietary Supplement: Blackcurrant and citrus extracts (low dose / low dose)

Treatment arm 3

EXPERIMENTAL

Participants will receive the placebo, blackcurrant extract (low dose), blackcurrant extract (high dose), blackcurrant and citrus extracts (low dose / low dose) at 4 separate study visits, in a random order. Visits will be separated by at least 7 days.

Dietary Supplement: Blackcurrant extract (low dose); Dietary Supplement: Placebo; Dietary Supplement: Blackcurrant extract (high dose); Dietary Supplement: Blackcurrant and citrus extracts (low dose / low dose)

Treatment arm 4

EXPERIMENTAL

Participants will receive the placebo, blackcurrant extract (low dose), citrus extract (low dose), blackcurrant and citrus extracts (low dose / low dose) at 4 separate study visits, in a random order. Visits will be separated by at least 7 days.

Dietary Supplement: Blackcurrant extract (low dose); Dietary Supplement: Placebo; Dietary Supplement: Citrus extract (low dose); Dietary Supplement: Blackcurrant and citrus extracts (low dose / low dose)

Interventions

Blackcurrant extract (low dose) DIETARY_SUPPLEMENT

Participants will consume a small beverage that contains blackcurrant extract (low dose) immediately before a high-carbohydrate meal.

Treatment arm 1; Treatment arm 3; Treatment arm 4

Placebo DIETARY_SUPPLEMENT

Participants will consume a small beverage that contains no fruit extracts immediately before a high-carbohydrate meal.

Treatment arm 1; Treatment arm 2; Treatment arm 3; Treatment arm 4

Citrus extract (low dose) DIETARY_SUPPLEMENT

Participants will consume a small beverage that contains citrus extract (low dose) immediately before a high-carbohydrate meal.

Treatment arm 1; Treatment arm 2; Treatment arm 4

Blackcurrant extract (high dose) DIETARY_SUPPLEMENT

Participants will consume a small beverage that contains blackcurrant extract (high dose) immediately before a high-carbohydrate meal.

Treatment arm 1; Treatment arm 2; Treatment arm 3

Blackcurrant and citrus extracts (low dose / low dose) DIETARY_SUPPLEMENT

Participants will consume a small beverage that contains blackcurrant and citrus extracts (low dose / low dose)immediately before a high-carbohydrate meal.

Treatment arm 2; Treatment arm 3; Treatment arm 4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-70 years
• Men and women

You may not qualify if:

• Body Mass Index 18-35 kg/m2
• Able to understand the information sheet and willing to comply with study protocol
• Able to give informed written consent
• 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.
• Full Blood Counts and Liver Function test results outside of the normal range.
• Current smokers, or reported giving up smoking within the last 6 months
• History of substance abuse or alcoholism
• Reported history of Cardiovascular disease, 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 48 h before the study
• Weight change \>3kg in preceding 2 months

Sponsors & Collaborators

• Lucozade Ribena Suntory: lead
• King's College London: collaborator

Study Sites (1)

Metabolic Research Unit

London, England, SE1 9NH, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 27764725 BACKGROUND

• Pinto AM, Hobden MR, Brown KD, Farrimond J, Targett D, Corpe CP, Ellis PR, Todorova Y, Socha K, Bahsoon S, Haworth C, Marcel M, Nie X, Hall WL. Acute effects of drinks containing blackcurrant and citrus (poly)phenols and dietary fibre on postprandial glycaemia, gut hormones, cognitive function and appetite in healthy adults: two randomised controlled trials. Food Funct. 2023 Nov 13;14(22):10163-10176. doi: 10.1039/d3fo03085g.

  PMID: 37902089 DERIVED

Study Officials

• Wendy L Hall, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Incomplete block cross-over design. Each participant receives placebo plus 3 out of 4 active treatments.

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: June 12, 2017
• Study Start: May 30, 2017
• Primary Completion: February 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 22, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)