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Effect of Polyphenol-rich Dark Chocolate on Insulin Sensitivity in Normal Weight and Overweight Adults

NCT ID: NCT01749020

Last Updated: 2013-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-07-31

Brief Summary

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The purpose of the study is to determine the effect of polyphenol-rich dark chocolate on insulin sensitivity in normal weight and overweight adults.

Detailed Description

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Polyphenols may have several favourable effects on health. Dark chocolate (DC) is one of the highest sources of polyphenols in foods. The aim of the study is to determine the effect of polyphenol-rich dark chocolate on insulin sensitivity in normal weight and overweight adults. Seventy four volunteers with no history of hypertension, cardiovascular diseases or diabetes will be recruited. Participants will randomly receive 20g daily of one of the two different types of DC: Placebo DC (low in polyphenols) or DC rich in polyphenols (500mg) for a period of four weeks. Participants will be asked to make two appointments to the university clinical lab. Anthropometric measurements (height, weight, waist circumference), blood and saliva samples will be taken during each of the 2 visits. Compliance will be tested by the measure of total polyphenols in a 24-hour urine sample in some random samples before and at the end of the intervention. To monitor any fluctuations in the participants' diet or physical activity during the study period, a three-day diet diary and a physical activity questionnaire will be collected before the start of the study and after four weeks. Data will be analysed with an ANCOVA with time (pre- and post-) and treatment (DC and placebo) as between-subject factor.

Conditions

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Insulin Resistance

Keywords

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Diabetes type II, Insulin sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Polyphenol-rich Dark chocolate

Dark chocolate with 500 mg of polyphenols

Group Type EXPERIMENTAL

Polyphenol-rich Dark chocolate

Intervention Type OTHER

Participants will be asked to consume 20g of dark chocolate containing 500mg of polyphenols daily for a period of 4 weeks

Placebo Dark chocolate

This chocolate contains little or no polyphenols

Group Type PLACEBO_COMPARATOR

Placebo Dark chocolate

Intervention Type OTHER

Participants will be asked to consume 20g of dark chocolate containing little or no polyphenols for a period of 4 weeks

Interventions

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Polyphenol-rich Dark chocolate

Participants will be asked to consume 20g of dark chocolate containing 500mg of polyphenols daily for a period of 4 weeks

Intervention Type OTHER

Placebo Dark chocolate

Participants will be asked to consume 20g of dark chocolate containing little or no polyphenols for a period of 4 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults with no history of hypertension, diabetes and cardiovascular diseases
* BMI from 18-24.9 and BMI \>25
* Males and Females
* Age: 18-65 years

Exclusion Criteria

* Participants with cardiovascular diseases, hypertension or diabetes
* Smokers and heavy alcohol drinkers
* Participants taking any medications that affect insulin, cholesterol, triglycerides or blood pressure
* Participants taking dietary supplements containing high doses of antioxidants
* Postmenopausal women taking HRT (Hormone Replacement Therapy)
* Participants who recently participated or are currently on a weight management program
* Participants with regular consumption of cocoa or DC (\> 1 serving/week)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Barry Callebaut

UNKNOWN

Sponsor Role collaborator

Queen Margaret University

OTHER

Sponsor Role lead

Responsible Party

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Grace Farhat

PhD research student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emad Al-Dujaili, PhD

Role: STUDY_DIRECTOR

Queen Margaret University

Locations

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Queen Margaret University Lab

Musselburgh, East Lothian, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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DC-Ins01

Identifier Type: -

Identifier Source: org_study_id