NCT01201590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 14, 2010

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

1.3 years

First QC Date

September 30, 2009

Last Update Submit

February 2, 2023

Conditions

Insulin Resistance

Keywords

Insulin resistanceobesitycocoawomen

Outcome Measures

Primary Outcomes (1)

  • Change in Insulin sensitivity 'M' value (mg glucose disposal from the blood/kg body weight/min),

    Insulin sensitivity calculated from glucose disposal during a hyperinsulinemic, euglycemic glucose clamp

    after 28 days of supplementation

Secondary Outcomes (1)

  • Change in Glucose Oxidation rate

    after 28 days of supplementation

Study Arms (2)

High Flavanol Cocoa

EXPERIMENTAL

609mg cocoa flavanols per 24g serving

Dietary Supplement: High Flavanol Cocoa

Low flavanol cocoa

PLACEBO COMPARATOR

13mg cocoa flavanols per 24g serving

Dietary Supplement: Low Flavanol Cocoa

Interventions

High Flavanol CocoaDIETARY_SUPPLEMENT

cocoa consumed as a 24g dairy based cocoa drink mix, twice a day (mid-morning \& early evening on an empty stomach), for 4 weeks.

High Flavanol Cocoa
Low Flavanol CocoaDIETARY_SUPPLEMENT

cocoa consumed as a 24g dairy based cocoa drink mix, twice a day (mid-morning \& early evening on an empty stomach), for 4 weeks.

Low flavanol cocoa

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David Greenfield Physiology Laboratories, University of Nottingham

Nottingham, Notts, NG72UH, United Kingdom

Location

Related Publications (1)

  • Simpson EJ, Mendis B, Dunlop M, Schroeter H, Kwik-Uribe C, Macdonald IA. Cocoa Flavanol Supplementation and the Effect on Insulin Resistance in Females Who Are Overweight or Obese: A Randomized, Placebo-Controlled Trial. Nutrients. 2023 Jan 21;15(3):565. doi: 10.3390/nu15030565.

    PMID: 36771271RESULT

MeSH Terms

Conditions

Insulin ResistanceObesity

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ian A Macdonald, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

September 30, 2009

First Posted

September 14, 2010

Study Start

March 1, 2009

Primary Completion

July 1, 2010

Study Completion

October 1, 2010

Last Updated

February 6, 2023

Record last verified: 2023-02

Locations

GB(1)