- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01749852
Effect of Polyphenol-rich Dark Chocolate on Body Weight in Overweight and Obese Adults
October 20, 2014 updated by: Grace Farhat, Queen Margaret University
Effect of Polyphenol-rich Dark Chocolate on Body Weight in Overweight and Obese Adults: A Pilot Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
East Lothian
-
Musselburgh, East Lothian, United Kingdom, EH21 6UU
- Queen Margaret University Lab
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Polyphenol-rich Dark chocolate
Dark chocolate with 500 mg of polyphenols
|
Participants will be asked to consume 20g of dark chocolate containing 500mg of polyphenols daily for a period of 12 weeks
|
Placebo Comparator: Placebo Dark chocolate
This chocolate contains little or no polyphenols
|
Participants will be asked to consume 20g of dark chocolate containing little or no polyphenols for a period of 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body weight
Time Frame: Baseline, week 6, week 12 and week 16
|
The body weight will be measured using a digital scale
|
Baseline, week 6, week 12 and week 16
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Body Fat percentage
Time Frame: Baseline, week 6, week 12 and week 16
|
Baseline, week 6, week 12 and week 16
|
Change in Waist circumference
Time Frame: Baseline, week 6, week 12 and week 16
|
Baseline, week 6, week 12 and week 16
|
Change in urinary Cortisol-to-cortisone ratio
Time Frame: Baseline, week 6 and week 12
|
Baseline, week 6 and week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Emad Al-Dujaili, PhD, Queen Margaret University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
December 10, 2012
First Submitted That Met QC Criteria
December 12, 2012
First Posted (Estimate)
December 17, 2012
Study Record Updates
Last Update Posted (Estimate)
October 21, 2014
Last Update Submitted That Met QC Criteria
October 20, 2014
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DC-BW 01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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