Effect of Polyphenol-rich Dark Chocolate on Obesity
Primary Purpose
Obesity
Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
placebo
Acticoa polyphenol-rich dark chocolate
Sponsored by

About this trial
This is an interventional prevention trial for Obesity
Eligibility Criteria
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
Sites / Locations
- Queen margaret university
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo dark chocolate
polyphenol-rich dark chocolate
Arm Description
polyphenol-poor dark chocolate
Outcomes
Primary Outcome Measures
adiponectin
Secondary Outcome Measures
insulin sensitivity
blood pressure
lipid profile
Full Information
NCT ID
NCT00815451
First Posted
December 29, 2008
Last Updated
September 17, 2009
Sponsor
Queen Margaret University
1. Study Identification
Unique Protocol Identification Number
NCT00815451
Brief Title
Effect of Polyphenol-rich Dark Chocolate on Obesity
Official Title
Effect of Polyphenols on Glucoregulatory Biomarkers, Blood Pressure and Lipid Profile in Overweight and Obese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Queen Margaret University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo dark chocolate
Arm Type
Placebo Comparator
Arm Description
polyphenol-poor dark chocolate
Arm Title
polyphenol-rich dark chocolate
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Other Intervention Name(s)
barry callebaut
Intervention Description
polyphenol-free dark chocolate 20g to be distributed throughout the day for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Acticoa polyphenol-rich dark chocolate
Other Intervention Name(s)
barry callebaut, acticoa
Intervention Description
20g to be distributed throughout the day for 4 weeks
Primary Outcome Measure Information:
Title
adiponectin
Time Frame
week 0, 4, 6, 10
Secondary Outcome Measure Information:
Title
insulin sensitivity
Time Frame
week 0, 4, 6, 10
Title
blood pressure
Time Frame
week 0, 4, 6, 10
Title
lipid profile
Time Frame
week 0, 4, 6, 10
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
suzana h almoosawi, BScHons HN
Organizational Affiliation
QMU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen margaret university
City
Musselburgh
State/Province
East Lothian
ZIP/Postal Code
eh21 6uu
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Effect of Polyphenol-rich Dark Chocolate on Obesity
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