NCT01706653

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

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

Study Start

First participant enrolled

October 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

September 16, 2019

Status Verified

September 1, 2019

Enrollment Period

5 months

First QC Date

October 10, 2012

Last Update Submit

September 12, 2019

Conditions

Healthy Men and Women

Keywords

PolyphenolFruitMetabolicHealthy

Study Arms (4)

Intervention 1

ACTIVE COMPARATOR

Polyphenol-enriched fruit-based drink - low

Dietary Supplement: Polyphenol-enriched fruit-based drink - low

Intervention 2

ACTIVE COMPARATOR

Polyphenol-enriched fruit-based drink - medium

Dietary Supplement: Polyphenol-enriched fruit-based drink - medium

Intervention 3

ACTIVE COMPARATOR

Polyphenol-enriched fruit-based drink - high

Dietary Supplement: Polyphenol-enriched fruit-based drink - high

Intervention 4

PLACEBO COMPARATOR

Very low polyphenol fruit based drink (control)

Dietary Supplement: Very low polyphenol fruit based drink (control)

Interventions

Polyphenol-enriched fruit-based drink - lowDIETARY_SUPPLEMENT
Intervention 1
Polyphenol-enriched fruit-based drink - mediumDIETARY_SUPPLEMENT
Intervention 2
Polyphenol-enriched fruit-based drink - highDIETARY_SUPPLEMENT
Intervention 3
Very low polyphenol fruit based drink (control)DIETARY_SUPPLEMENT
Intervention 4

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes & Nutritional Sciences Division, School of Medicine, King's College London

London, SE1 9NH, United Kingdom

Location

Related Publications (1)

  • 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: 27764725DERIVED

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Nutritional Sciences

Study Record Dates

First Submitted

October 10, 2012

First Posted

October 15, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2013

Study Completion

April 1, 2013

Last Updated

September 16, 2019

Record last verified: 2019-09

Locations

GB(1)