The Effects of Cocoa Flavanols on Insulin Resistance in an 'At-risk' Population

This study has been completed.
Sponsor:
Collaborator:
Mars, Inc.
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01201590
First received: September 30, 2009
Last updated: July 14, 2014
Last verified: July 2014

September 30, 2009
July 14, 2014
March 2009
July 2010   (final data collection date for primary outcome measure)
Change in Insulin sensitivity 'M' value (mg glucose disposal from the blood/kg body weight/min), [ Time Frame: after 28 days of supplementation ] [ Designated as safety issue: No ]
Insulin sensitivity calculated from glucose disposal during a hyperinsulinemic, euglycemic glucose clamp
Insulin sensitivity 'M' value (mg glucose disposal from the blood/kg body weight/min), [ Time Frame: after 28 days of dosing ] [ Designated as safety issue: No ]
Insulin sensitivity calculated from glucose disposal during a hyperinsulinemic, euglycemic glucose clamp
Complete list of historical versions of study NCT01201590 on ClinicalTrials.gov Archive Site
Change in Glucose Oxidation rate [ Time Frame: after 28 days of supplementation ] [ Designated as safety issue: No ]
Measured by ventilated hood indirect calorimetry during the glucose clamp.
Glucose Oxidation rate [ Time Frame: after 28 days of dosing ] [ Designated as safety issue: No ]
Measured by ventilated hood indirect calorimetry on the 2 study days, before and during the glucose clamp.
Not Provided
Not Provided
 
The Effects of Cocoa Flavanols on Insulin Resistance in an 'At-risk' Population
The Effects of Cocoa Flavanols on Insulin Resistance in at 'At-risk' Population

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, who are otherwise healthy, will be recruited. Subjects will attend the laboratory on 3 occasions after fasting from midnight. The 1st visit is a medical screening, with laboratory visits 2 and 3 separated by 4 weeks, during which time subjects will consume a cocoa drink (containing either high or low amounts of flavanols) twice a day. Subjects will record their food intake for 3-days before visit 2 and in week 3 of consuming the cocoa. They will also eat a diet of standard macronutrient composition for 3 days before visits 2 and 3. During the 5 hour laboratory visits, subjects will have a scan to assess their body composition using a low-dose x-ray machine (Dual Energy X-ray Absorptiometry; DEXA), and have their insulin sensitivity measured using a 3 hour hyperinsulinemic, euglycaemic Clamp.

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 encouraged to lose weight to reduce their risk of progressing to type 2 diabetes and coronary heart disease, but there is clearly a potential role for dietary modifications to maximize any potential benefit of this weight loss. Cocoa flavanols (CF) are known to have vascular effects which might enhance substrate delivery to metabolically active tissues, and thus improve insulin sensitivity.

Aims; This randomized, double blind, placebo controlled, parallel design study aims to investigate the longer term effects of CF intake on insulin sensitivity. It is hypothesized that studying otherwise healthy overweight and mildly obese subjects, with evidence of fasting insulin resistance, would show whether there was potential benefit of CF in an 'at risk' population.

Experimental protocol and methods; 32 overweight or obese women (Body Mass Index 27-35), who are otherwise healthy, will be recruited onto the study. They will attend the 'David Greenfield Human Physiology' laboratories on 3 convenient mornings, following an overnight fast. The 1st visit is a medical screening and will involve signing a consent form, completing a medical screening and food frequency questionnaire, having height, weight, hip/waist circumference measurements taken and a 10ml sample of blood taken for routine analysis. Subjects will then be asked to complete a 3-day diet diary for macronutrient assessment and to consume a diet providing 50% of energy as carbohydrate for 3 days prior to the 2nd laboratory visit. This 2nd visit will involve having a DEXA body composition scan and a 3-hour hyperinsulinaemic, euglycaemic glucose clamp. Starting on the following morning, subjects will then consume a cocoa drink (containing either 450mg or 25mg of CF) twice a day for 28 days. A 3-day diet diary for macronutrient assessment will be recorded during week 3 of taking the cocoa and a standardized diet will be consumed for 3 days prior to the final laboratory visit, as before. This 3rd visit will be identical to visit 2 and occur immediately after 28days of taking the cocoa.

Measurable end points Insulin sensitivity 'M' value (mg glucose disposal from the blood/kg body weight.min), Respiratory exchange ratio, Resting metabolic rate, Homeostatic model assessment for insulin resistance (HOMA-IR) Body composition (DEXA) Macronutrient composition of the diet before and during the intervention period

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Insulin Resistance
  • Dietary Supplement: High Flavanol Cocoa
    cocoa consumed as a 24g dairy based cocoa drink mix, twice a day (mid-morning & early evening on an empty stomach), for 4 weeks.
  • Dietary Supplement: Low Flavanol Cocoa
    cocoa consumed as a 24g dairy based cocoa drink mix, twice a day (mid-morning & early evening on an empty stomach), for 4 weeks.
  • Experimental: High Flavanol Cocoa
    609mg cocoa flavanols per 24g serving
    Intervention: Dietary Supplement: High Flavanol Cocoa
  • Placebo Comparator: Low flavanol cocoa
    13mg cocoa flavanols per 24g serving
    Intervention: Dietary Supplement: Low Flavanol Cocoa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
October 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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)
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01201590
1000165377
No
University of Nottingham
University of Nottingham
Mars, Inc.
Principal Investigator: Ian A Macdonald, PhD University of Nottingham
University of Nottingham
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP