Effect of Polyphenol-rich Dark Chocolate on Obesity
Effect of Polyphenols on Glucoregulatory Biomarkers, Blood Pressure and Lipid Profile in Overweight and Obese Subjects
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 obesity
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 29, 2008
CompletedFirst Posted
Study publicly available on registry
December 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedSeptember 18, 2009
September 1, 2009
11 months
December 29, 2008
September 17, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
adiponectin
week 0, 4, 6, 10
Secondary Outcomes (3)
insulin sensitivity
week 0, 4, 6, 10
blood pressure
week 0, 4, 6, 10
lipid profile
week 0, 4, 6, 10
Study Arms (2)
placebo dark chocolate
PLACEBO COMPARATORpolyphenol-poor dark chocolate
polyphenol-rich dark chocolate
EXPERIMENTALInterventions
polyphenol-free dark chocolate 20g to be distributed throughout the day for 4 weeks
20g to be distributed throughout the day for 4 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen margaret university
Musselburgh, east lothian, eh21 6uu, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
suzana h almoosawi, BScHons HN
QMU
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 29, 2008
First Posted
December 30, 2008
Study Start
November 1, 2008
Primary Completion
October 1, 2009
Study Completion
December 1, 2009
Last Updated
September 18, 2009
Record last verified: 2009-09