NCT01749852

Brief Summary

The aim of this study is to investigate if dark chocolate rich in polyphenols decreases body weight/ body fat in the overweight and obese adult population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

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

December 10, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

October 21, 2014

Status Verified

May 1, 2013

Enrollment Period

6 months

First QC Date

December 10, 2012

Last Update Submit

October 20, 2014

Conditions

Body Weight

Outcome Measures

Primary Outcomes (1)

  • Change in Body weight

    The body weight will be measured using a digital scale

    Baseline, week 6, week 12 and week 16

Secondary Outcomes (3)

  • Change in Body Fat percentage

    Baseline, week 6, week 12 and week 16

  • Change in Waist circumference

    Baseline, week 6, week 12 and week 16

  • Change in urinary Cortisol-to-cortisone ratio

    Baseline, week 6 and week 12

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 12 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 12 weeks

Placebo Dark chocolate

Eligibility Criteria

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

You may qualify if:

  • Healthy adults
  • BMI between 25-35
  • Males and Females
  • Age: 18-65 years

You may not qualify if:

  • Participants with cardiovascular diseases, hypertension or diabetes
  • Participants taking any medications that affect insulin, cholesterol, triglycerides or Blood pressure
  • 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

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

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 17, 2012

Study Start

January 1, 2013

Primary Completion

July 1, 2013

Study Completion

January 1, 2014

Last Updated

October 21, 2014

Record last verified: 2013-05

Locations

GB(1)