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Effect of Polyphenol-rich Dark Chocolate on Obesity

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00815451
Enrollment
50
Registered
2008-12-30
Start date
2008-11-30
Completion date
2009-12-31
Last updated
2009-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

DIETARY_SUPPLEMENTplacebo

polyphenol-free dark chocolate 20g to be distributed throughout the day for 4 weeks

DIETARY_SUPPLEMENTActicoa polyphenol-rich dark chocolate

20g to be distributed throughout the day for 4 weeks

Sponsors

Queen Margaret University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frame
adiponectinweek 0, 4, 6, 10

Secondary

MeasureTime frame
insulin sensitivityweek 0, 4, 6, 10
blood pressureweek 0, 4, 6, 10
lipid profileweek 0, 4, 6, 10

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026