Clinical trial NCT00815451: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Queen Margaret University
Sponsor class: OTHER
First posted: 2008-12-30
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: adiponectin
timeFrame: week 0, 4, 6, 10
Secondary outcomes:
measure: insulin sensitivity
timeFrame: week 0, 4, 6, 10
measure: blood pressure
timeFrame: week 0, 4, 6, 10
measure: lipid profile
timeFrame: week 0, 4, 6, 10
Other outcomes:
Locations:
city: Musselburgh
country: United Kingdom
facility: Queen margaret university
state: East Lothian
Study officials:
affiliation: QMU
name: suzana h almoosawi, BScHons HN
role: PRINCIPAL_INVESTIGATOR
References: