Effect of Polyphenol-rich Dark Chocolate on Obesity
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Dietary Supplement: placebo Dietary Supplement: Acticoa polyphenol-rich dark chocolate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Effect of Polyphenols on Glucoregulatory Biomarkers, Blood Pressure and Lipid Profile in Overweight and Obese Subjects |
- adiponectin [ Time Frame: week 0, 4, 6, 10 ] [ Designated as safety issue: No ]
- insulin sensitivity [ Time Frame: week 0, 4, 6, 10 ] [ Designated as safety issue: No ]
- blood pressure [ Time Frame: week 0, 4, 6, 10 ] [ Designated as safety issue: No ]
- lipid profile [ Time Frame: week 0, 4, 6, 10 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: placebo dark chocolate
polyphenol-poor dark chocolate
|
Dietary Supplement: placebo
polyphenol-free dark chocolate 20g to be distributed throughout the day for 4 weeks
Other Name: barry callebaut
|
| Experimental: polyphenol-rich dark chocolate |
Dietary Supplement: Acticoa polyphenol-rich dark chocolate
20g to be distributed throughout the day for 4 weeks
Other Name: barry callebaut, acticoa
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United Kingdom | |
| Queen margaret university | |
| Musselburgh, East Lothian, United Kingdom, eh21 6uu | |
| Principal Investigator: | suzana h almoosawi, BScHons HN | QMU |
More Information
No publications provided
| Responsible Party: | suzana almoosawi, PhD student QMU |
| ClinicalTrials.gov Identifier: | NCT00815451 History of Changes |
| Other Study ID Numbers: | 1-salmoosawi |
| Study First Received: | December 29, 2008 |
| Last Updated: | September 17, 2009 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013