Clinical trial NCT01749852: 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
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight
Lead sponsor: Queen Margaret University
Sponsor class: OTHER
Collaborators: name: Barry Callebaut
First posted: 2012-12-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: Change in Body weight
timeFrame: Baseline, week 6, week 12 and week 16
Secondary outcomes:
measure: Change in Body Fat percentage
timeFrame: Baseline, week 6, week 12 and week 16
measure: Change in Waist circumference
timeFrame: Baseline, week 6, week 12 and week 16
measure: Change in urinary Cortisol-to-cortisone ratio
timeFrame: Baseline, week 6 and week 12
Other outcomes:
Locations:
city: Musselburgh
country: United Kingdom
facility: Queen Margaret University Lab
state: East Lothian
Study officials:
affiliation: Queen Margaret University
name: Emad Al-Dujaili, PhD
role: STUDY_DIRECTOR
References: