Effect of Polyphenol-rich Dark Chocolate on Obesity

Obesity Clinical Trial

Official title:

Effect of Polyphenols on Glucoregulatory Biomarkers, Blood Pressure and Lipid Profile in Overweight and Obese Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00815451
• Other study ID #: 1-salmoosawi
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 29, 2008
• Last updated: September 17, 2009
• Start date: November 2008
• Est. completion date: December 2009

Study information

• Verified date: September 2009
• Source: Queen Margaret University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the effect of polyphenol-rich dark chocolate (DC) on insulin resistance, adiponectin , blood pressure (BP), lipid profile in obese subjects and determine possible associations between all assessed parameters.

It hypothesizes that consumption of polyphenol-rich Dc could lower fasting glucose levels, insulin resistance and improve BP, total cholesterol, low-density lipoprotein (LDL) and triglycerides while increasing adiponectin and high-density lipoprotein (HDL) in overweight or obese individuals.

Description:

It is well acknowledged that the main mechanism by which cocoa and DC polyphenols improve fasting glucose levels, insulin sensitivity, BP and lipid profile in healthy individuals and those with hypertension and/or impaired glucose-tolerance, involves increased nitric oxide (NO) bioavailability. NO is essential for the regulation of blood pressure, glucose and lipid balance. This is evident in that e-NOsynthase knockout mice exhibit insulin resistance, hypertension and hyperlipidemia, a cluster of diseases that is also observed in the metabolic syndrome. Recently, it was shown that adiponectin regulates eNOsynthase activity through the phosphatidylinositol 3-kinase-dependent pathway wherein eNOsynthase is phosphorylated by 5'-AMP-activated protein kinase at Ser1179 and that plasma adiponectin levels are inversely correlated with BMI, waist-to-hip ratio, fasting plasma glucose, insulin, triglyceride, hyperinsulinemia, and glucose intolerance and positively with HDL-cholesterol, but not BP. This suggests a strong link between impaired NO bioavailability, adiponectin levels and obesity. Indeed, apart from exhibiting impaired NO bioavailability, obese individuals also have decreased plasma adiponectin levels. Since cocoa and DC are known to modulate NO activity, investigating the impact of cocoa or DC polyphenols on adiponectin levels and observing a correlation between its levels and improved fasting glucose levels, insulin resistance, BP and lipid profile is essential in improving our understanding of the relationship between diet and health, particularly that polyphenols in apples, oolong and green tea polyphenols have been previously shown to influence adiponectin levels.

This study uses a randomised single-blind, placebo-controlled design. Following a 1-week run-in phase, each group will be randomised to one of the two groups: placebo-polyphenol-rich DC, polyphenol-rich DC-placebo. Subjects will follow each diet for 4weeks, after which they will cross-over to the next diet separated by a 2-week washout period and until each subject completes both interventions.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy female volunteers

• Aged 18-50 years

• Group 1 will consist of volunteers with BMI of 18-25 kg/m2

• Group 2 will consist of women with BMI of 25-35 kg/m2

Exclusion Criteria:

• Cardiovascular disease

• Hypertension

• Diabetes

• Smokers

• People taking dietary supplements

• Hypertension or cholesterol-lowering drugs

• Those with high cocoa or DC intake, soy or nut allergies

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• placebo
polyphenol-free dark chocolate 20g to be distributed throughout the day for 4 weeks
• Acticoa polyphenol-rich dark chocolate
20g to be distributed throughout the day for 4 weeks

Locations

Country	Name	City	State
United Kingdom	Queen margaret university	Musselburgh	East Lothian

Sponsors (1)

Lead Sponsor	Collaborator
Queen Margaret University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adiponectin		week 0, 4, 6, 10	No
Secondary	insulin sensitivity		week 0, 4, 6, 10	No
Secondary	blood pressure		week 0, 4, 6, 10	No
Secondary	lipid profile		week 0, 4, 6, 10	No