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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Polyphenol-rich Dark Chocolate on Body Weight in Overweight and Obese Adults: A Pilot Study

Conditions
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Body Weight

Intervention / Treatment
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* Other: Polyphenol-rich Dark chocolate
* Other: Placebo Dark chocolate


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polyphenol-rich Dark chocolate<br>Dark chocolate with 500 mg of polyphenols | Other: Polyphenol-rich Dark chocolate<br>* Participants will be asked to consume 20g of dark chocolate containing 500mg of polyphenols daily for a period of 12 weeks<br>|
| Placebo Comparator: Placebo Dark chocolate<br>This chocolate contains little or no polyphenols | Other: Placebo Dark chocolate<br>* Participants will be asked to consume 20g of dark chocolate containing little or no polyphenols for a period of 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body weight | The body weight will be measured using a digital scale | Baseline, week 6, week 12 and week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |