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

NCT ID: NCT01749852

Last Updated: 2014-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-01-31

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.

Conditions

Body Weight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Polyphenol-rich Dark chocolate

Dark chocolate with 500 mg of polyphenols

Group Type: EXPERIMENTAL

Polyphenol-rich Dark chocolate

Intervention Type: OTHER

Participants will be asked to consume 20g of dark chocolate containing 500mg of polyphenols daily for a period of 12 weeks

Placebo Dark chocolate

This chocolate contains little or no polyphenols

Group Type: PLACEBO_COMPARATOR

Placebo Dark chocolate

Intervention Type: OTHER

Participants will be asked to consume 20g of dark chocolate containing little or no polyphenols for a period of 12 weeks

Interventions

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

Intervention Type: OTHER

Placebo Dark chocolate

Participants will be asked to consume 20g of dark chocolate containing little or no polyphenols for a period of 12 weeks

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Barry Callebaut

UNKNOWN

Sponsor Role: collaborator

Queen Margaret University

OTHER

Sponsor Role: lead

Responsible Party

Grace Farhat

PhD research student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emad Al-Dujaili, PhD

Role: STUDY_DIRECTOR

Queen Margaret University

Locations

Queen Margaret University Lab

Musselburgh, East Lothian, United Kingdom

Countries

United Kingdom

Other Identifiers

DC-BW 01

Identifier Type: -

Identifier Source: org_study_id