NCT00324090

Brief Summary

The purpose of this study is to investigate the effect of a diet with either high or low glycemic index (GI) on ad libitum (free) food intake, body weight, fat mass and fat-free mass, risk markers for diabetes and cardiovascular diseases, energy expenditure and substrate oxidation after 10 weeks´ intake in slightly overweight subjects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2002

Shorter than P25 for not_applicable

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, 2002

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2006

Completed
Last Updated

January 21, 2009

Status Verified

February 1, 2002

First QC Date

May 9, 2006

Last Update Submit

January 20, 2009

Conditions

OverweightObesity

Outcome Measures

Primary Outcomes (3)

  • Body weight

  • Fat mass and fat-free mass

  • Food intake

Secondary Outcomes (3)

  • Risk markers for diabetes and CVD

  • Energy expenditure and substrate oxidation

  • Appetite

Interventions

High and low glycemic indexBEHAVIORAL

Eligibility Criteria

Age20 Years - 41 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy, slightly overweight (body mass index, BMI = 25-30 kg/m2) women, premenopausal, non-alcoholic (\< 14 units alcohol/w)

You may not qualify if:

  • smoking, elite athletes, food allergies, pregnant, lactating, on medication, blood donation 3 months before, during and 3 months after the completion of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Krog-Mikkelsen I, Sloth B, Dimitrov D, Tetens I, Bjorck I, Flint A, Holst JJ, Astrup A, Elmstahl H, Raben A. A low glycemic index diet does not affect postprandial energy metabolism but decreases postprandial insulinemia and increases fullness ratings in healthy women. J Nutr. 2011 Sep;141(9):1679-84. doi: 10.3945/jn.110.134627. Epub 2011 Jul 20.

    PMID: 21775528DERIVED

  • Jensen L, Sloth B, Krog-Mikkelsen I, Flint A, Raben A, Tholstrup T, Brunner N, Astrup A. A low-glycemic-index diet reduces plasma plasminogen activator inhibitor-1 activity, but not tissue inhibitor of proteinases-1 or plasminogen activator inhibitor-1 protein, in overweight women. Am J Clin Nutr. 2008 Jan;87(1):97-105. doi: 10.1093/ajcn/87.1.97.

    PMID: 18175742DERIVED

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Arne Astrup, Prof

    Department of Human Nutrition, Centre for Advanced Food Studies, The Royal Veterinary and Agricultural University, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 9, 2006

First Posted

May 10, 2006

Study Start

March 1, 2002

Study Completion

July 1, 2002

Last Updated

January 21, 2009

Record last verified: 2002-02