Status:
COMPLETED
The Effects of Cocoa Flavanols on Insulin Resistance in an 'At-risk' Population
Lead Sponsor:
University of Nottingham
Collaborating Sponsors:
Mars, Inc.
Conditions:
Insulin Resistance
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
The aim of the current study is to investigate the ability of antioxidants found in cocoa ('flavanols') to increase the body's sensitivity to the hormone insulin. 32 overweight or mildly obese women, ...
Detailed Description
Background; Overweight and mild obesity are associated with insulin resistance and mild elevations in lipid risk factors which are not usually sufficiently abnormal to merit treatment. Such people are...
Eligibility Criteria
Inclusion
- female,
- aged \> 18 years,
- pre-menopausal,
- Body Mass Index (BMI)27-35,
- homeostatic model assessment-Insulin Resistance(HOMA-IR)value \> 1.5,
- daily consumption of caffeine containing foods/drinks
Exclusion
- pregnant or breast feeding,
- any metabolic or endocrine abnormalities,
- clinically significant abnormalities on screening,
- fasting glucose \> 6.0mmol/l,
- taking medication other than the contraceptive pill,
- herbal supplement use,
- food allergies related to the investigational product (cocoa, peanuts, milk)
- sensitivity to methylxanthines (e.g., caffeine, theobromine)
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01201590
Start Date
March 1 2009
End Date
October 1 2010
Last Update
February 6 2023
Active Locations (1)
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1
David Greenfield Physiology Laboratories, University of Nottingham
Nottingham, Notts, United Kingdom, NG72UH