NCT01749020

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

November 20, 2013

Status Verified

November 1, 2013

Enrollment Period

1.3 years

First QC Date

December 10, 2012

Last Update Submit

November 19, 2013

Conditions

Insulin Resistance

Keywords

Diabetes type II, Insulin sensitivity

Outcome Measures

Primary Outcomes (1)

  • Determine if the consumption of DC rich in polyphenols can induce a change in insulin sensitivity

    Insulin sensitivity will be determined by determined by HOMA-IR (Homeostasis Model of Assessment - Insulin Resistance)

    Baseline and week 4

Secondary Outcomes (7)

  • Determine if the consumption of DC rich in polyphenols can induce a change in glucose levels

    Baseline and week 4

  • Determine if the consumption of DC rich in polyphenols can induce a change in Lipid profile (TC, HDL, LDL & TG)

    Baseline and week 4

  • Determine if the consumption of DC rich in polyphenols can induce a change in oxidized LDL levels

    Baseline and week 4

  • Determine if the consumption of DC rich in polyphenols can induce a change in BMI and Waist circumference

    Baseline and week 4

  • Determine if the consumption of DC rich in polyphenols can induce a change in blood pressure

    Baseline and week 4

  • +2 more secondary outcomes

Study Arms (2)

Polyphenol-rich Dark chocolate

EXPERIMENTAL

Dark chocolate with 500 mg of polyphenols

Other: Polyphenol-rich Dark chocolate

Placebo Dark chocolate

PLACEBO COMPARATOR

This chocolate contains little or no polyphenols

Other: Placebo Dark chocolate

Interventions

Polyphenol-rich Dark chocolateOTHER

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

Polyphenol-rich Dark chocolate
Placebo Dark chocolateOTHER

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

Placebo Dark chocolate

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Margaret University Lab

Musselburgh, East Lothian, EH21 6UU, United Kingdom

Location

MeSH Terms

Conditions

Insulin ResistanceDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Study Officials

  • Emad Al-Dujaili, PhD

    Queen Margaret University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD research student

Study Record Dates

First Submitted

December 10, 2012

First Posted

December 13, 2012

Study Start

March 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

November 20, 2013

Record last verified: 2013-11

Locations

GB(1)