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Effect of Polyphenol-rich Dark Chocolate on Body Weight in Overweight and Obese Adults

Primary Purpose

Body Weight

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Polyphenol-rich Dark chocolate
Placebo Dark chocolate
Sponsored by
Queen Margaret University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Body Weight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Queen Margaret University Lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Polyphenol-rich Dark chocolate

Placebo Dark chocolate

Arm Description

Dark chocolate with 500 mg of polyphenols

This chocolate contains little or no polyphenols

Outcomes

Primary Outcome Measures

Change in Body weight
The body weight will be measured using a digital scale

Secondary Outcome Measures

Change in Body Fat percentage
Change in Waist circumference
Change in urinary Cortisol-to-cortisone ratio

Full Information

First Posted
December 10, 2012
Last Updated
October 20, 2014
Sponsor
Queen Margaret University
Collaborators
Barry Callebaut
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1. Study Identification

Unique Protocol Identification Number
NCT01749852
Brief Title
Effect of Polyphenol-rich Dark Chocolate on Body Weight in Overweight and Obese Adults
Official Title
Effect of Polyphenol-rich Dark Chocolate on Body Weight in Overweight and Obese Adults: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Margaret University
Collaborators
Barry Callebaut

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Polyphenols are phytochemicals widely available in plants, and may have several favourable effects on health. Dark chocolate (DC) is one of the highest sources of polyphenols in foods. Animal and in vitro studies have demonstrated that cocoa and dark chocolate may exert anti-obesity effects mainly due to the polyphenol effect on glucose and fatty acid metabolism. Human studies have showed that regular chocolate eaters have a lower body weight compared to non regular eaters, and that DC promotes satiety and reduces cravings. The aim of this pilot study is to investigate the effect of polyphenol-rich DC on body weight in the overweight and obese adult population, when incorporated into a non-restricted diet. Twenty-eight apparently healthy volunteers 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 twelve weeks. Participants will be asked to make three appointments and one follow-up appointment to the university clinical lab. Anthropometric measurements (height, weight, waist circumference, body fat percentage) will be taken during each visit. Compliance will be defined by the intake of 85 % or more of the chocolate weekly, and will be tested by the measure of total polyphenols in a 24-hour urine sample before, during 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, a Food Frequency questionnaire assessment for polyphenol intake and a physical activity questionnaire will be collected before the start of the study and every four weeks. A follow-up appointment (four weeks after the end of intervention) will check if any differences in anthropometric measures have been maintained. Data will be analysed with an ANCOVA with time (pre- and post-) and treatment (DC and placebo) as between-subject factor. This study will have novel findings and will be the basis for a future larger trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polyphenol-rich Dark chocolate
Arm Type
Experimental
Arm Description
Dark chocolate with 500 mg of polyphenols
Arm Title
Placebo Dark chocolate
Arm Type
Placebo Comparator
Arm Description
This chocolate contains little or no polyphenols
Intervention Type
Other
Intervention Name(s)
Polyphenol-rich Dark chocolate
Intervention Description
Participants will be asked to consume 20g of dark chocolate containing 500mg of polyphenols daily for a period of 12 weeks
Intervention Type
Other
Intervention Name(s)
Placebo Dark chocolate
Intervention Description
Participants will be asked to consume 20g of dark chocolate containing little or no polyphenols for a period of 12 weeks
Primary Outcome Measure Information:
Title
Change in Body weight
Description
The body weight will be measured using a digital scale
Time Frame
Baseline, week 6, week 12 and week 16
Secondary Outcome Measure Information:
Title
Change in Body Fat percentage
Time Frame
Baseline, week 6, week 12 and week 16
Title
Change in Waist circumference
Time Frame
Baseline, week 6, week 12 and week 16
Title
Change in urinary Cortisol-to-cortisone ratio
Time Frame
Baseline, week 6 and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults BMI between 25-35 Males and Females Age: 18-65 years Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emad Al-Dujaili, PhD
Organizational Affiliation
Queen Margaret University
Official's Role
Study Director
Facility Information:
Facility Name
Queen Margaret University Lab
City
Musselburgh
State/Province
East Lothian
ZIP/Postal Code
EH21 6UU
Country
United Kingdom

12. IPD Sharing Statement

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Effect of Polyphenol-rich Dark Chocolate on Body Weight in Overweight and Obese Adults

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