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

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ClinicalTrials.gov Identifier: NCT01201590
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
Mars, Inc.
Information provided by (Responsible Party):
Elizabeth Simpson, University of Nottingham

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, 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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Dietary Supplement: High Flavanol Cocoa Dietary Supplement: Low Flavanol Cocoa Not Applicable

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 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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Cocoa Flavanols on Insulin Resistance in at 'At-risk' Population
Study Start Date : March 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: High Flavanol Cocoa
609mg cocoa flavanols per 24g serving
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.
Placebo Comparator: Low flavanol cocoa
13mg cocoa flavanols per 24g serving
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.



Primary Outcome Measures :
  1. Change in Insulin sensitivity 'M' value (mg glucose disposal from the blood/kg body weight/min), [ Time Frame: after 28 days of supplementation ]
    Insulin sensitivity calculated from glucose disposal during a hyperinsulinemic, euglycemic glucose clamp


Secondary Outcome Measures :
  1. Change in Glucose Oxidation rate [ Time Frame: after 28 days of supplementation ]
    Measured by ventilated hood indirect calorimetry during the glucose clamp.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201590


Locations
United Kingdom
David Greenfield Physiology Laboratories, University of Nottingham
Nottingham, Notts, United Kingdom, NG72UH
Sponsors and Collaborators
University of Nottingham
Mars, Inc.
Investigators
Principal Investigator: Ian A Macdonald, PhD University of Nottingham

Responsible Party: Elizabeth Simpson, Senior Research Fellow, University of Nottingham
ClinicalTrials.gov Identifier: NCT01201590     History of Changes
Other Study ID Numbers: 1000165377
First Posted: September 14, 2010    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

Keywords provided by Elizabeth Simpson, University of Nottingham:
Insulin resistance
obesity
cocoa
women

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs