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

NCT01201590 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-02-06

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Mars, Inc.

    collaborator INDUSTRY

  • University of Nottingham

    lead OTHER

Principal Investigators

  • Ian A Macdonald, PhD · University of Nottingham

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-07-31
Completion
2010-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01201590 on ClinicalTrials.gov