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

Body Weight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749852
• Other study ID #: DC-BW 01
• Status: Completed
• Phase: N/A
• First received: December 10, 2012
• Last updated: October 20, 2014
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: May 2013
• Source: Queen Margaret University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Body Weight

Intervention

Other:
• Polyphenol-rich Dark chocolate
Participants will be asked to consume 20g of dark chocolate containing 500mg of polyphenols daily for a period of 12 weeks
• Placebo Dark chocolate
Participants will be asked to consume 20g of dark chocolate containing little or no polyphenols for a period of 12 weeks

Locations

Country	Name	City	State
United Kingdom	Queen Margaret University Lab	Musselburgh	East Lothian

Sponsors (2)

Lead Sponsor	Collaborator
Queen Margaret University	Barry Callebaut

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body weight	The body weight will be measured using a digital scale	Baseline, week 6, week 12 and week 16	No
Secondary	Change in Body Fat percentage		Baseline, week 6, week 12 and week 16	No
Secondary	Change in Waist circumference		Baseline, week 6, week 12 and week 16	No
Secondary	Change in urinary Cortisol-to-cortisone ratio		Baseline, week 6 and week 12	No