NCT03572296

Brief Summary

Postprandial glycaemia refers to the transient rise in blood glucose levels that occurs after consuming a meal. Large fluctuations in blood glucose levels, experienced on a frequent basis, may impair the functioning of pancreatic beta cells, and thus elevate the risk of developing type 2 diabetes mellitus (T2DM) and cardiovascular disease. Our group has previously shown that consuming a drink containing fruit polyphenols immediately before a meal, may reduce postprandial glycaemia. Importantly, other fruit components, namely soluble fibres, also impact on carbohydrate digestion by slowing gastric emptying rates. Combining fruit polyphenols and fibre in a drink may, potentially, have additive or synergistic effects on reducing postprandial glycaemia. This study will investigate the effects of drinks containing blackcurrant polyphenol extract combined with pulp (source of fibre), and pulp alone, on postprandial outcomes and cognitive function following a mixed carbohydrate (starch and sucrose) test meal.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

June 25, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 28, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2019

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

June 19, 2018

Last Update Submit

January 30, 2019

Conditions

Postprandial Period

Keywords

BlackcurrantPolyphenolsPulpFibreGlucosePostprandialMetabolismCognition

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 (24)

  • Postprandial glycaemia: iAUC 0-120 min

    120 min

  • Postprandial glycaemia: iAUC 0-150 min

    150 min

  • Postprandial glycaemia: iCmax

    150 min

  • Postprandial glycaemia: Tmax

    150 min

  • Postprandial glycaemia: absolute concentrations at specific time points

    150 min

  • +19 more secondary outcomes

Other Outcomes (6)

  • 7-d food diary (estimated/unweighed)

    7-days

  • 100 mm visual analogue scale (VAS) measures of the palatability of the study drink

    10 min following the test drink

  • 100 mm visual analogue scale (VAS) measures of mood, satiety and digestive comfort

    150 min

  • +3 more other outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

No polyphenols or fibre will be delivered in a low sugar drink.

Dietary Supplement: Placebo

Polyphenol and fibre

EXPERIMENTAL

Blackcurrant extract (800 mg total polyphenols) and pulp (source of fibre) will be delivered in a low sugar drink.

Dietary Supplement: Polyphenol and fibre

Fibre

EXPERIMENTAL

Pulp (source of fibre) will be delivered in a low sugar drink.

Dietary Supplement: Fibre

Interventions

PlaceboDIETARY_SUPPLEMENT

Drinks will be delivered in random order at 3 separate study visits immediately before a high carbohydrate meal. A minimum of 4 days (ideally 7 days) wash-out period will be required between study days.

Placebo
Polyphenol and fibreDIETARY_SUPPLEMENT

Drinks will be delivered in random order at 3 separate study visits immediately before a high carbohydrate meal. A minimum of 4 days (ideally 7 days) wash-out period will be required between study days.

Polyphenol and fibre
FibreDIETARY_SUPPLEMENT

Drinks will be delivered in random order at 3 separate study visits immediately before a high carbohydrate meal. A minimum of 4 days (ideally 7 days) wash-out period will be required between study days.

Fibre

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 breastfeeding
  • 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/ high fibre foods for 48 h before the study
  • Weight change \>3 kg in preceding 2 months
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Metabolic Research Unit

London, 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: 27764725BACKGROUND

  • 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: 37902089DERIVED

MeSH Terms

Interventions

PolyphenolsDietary Fiber

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

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
Model Details: Cross-over design. Each participant receives placebo plus 2 treatments.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2018

First Posted

June 28, 2018

Study Start

June 25, 2018

Primary Completion

January 28, 2019

Study Completion

January 28, 2019

Last Updated

January 31, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)