Glycemic Index, Body Weight and Health
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High and low glycemic index
Sponsored by
About this trial
This is an interventional prevention trial for Overweight
Eligibility Criteria
Inclusion Criteria: healthy, slightly overweight (body mass index, BMI = 25-30 kg/m2) women, premenopausal, non-alcoholic (< 14 units alcohol/w) Exclusion Criteria: smoking, elite athletes, food allergies, pregnant, lactating, on medication, blood donation 3 months before, during and 3 months after the completion of the study
Sites / Locations
Outcomes
Primary Outcome Measures
Body weight
Fat mass and fat-free mass
Food intake
Secondary Outcome Measures
Risk markers for diabetes and CVD
Energy expenditure and substrate oxidation
Appetite
Full Information
NCT ID
NCT00324090
First Posted
May 9, 2006
Last Updated
January 20, 2009
Sponsor
University of Copenhagen
Collaborators
Danone Vitapole, France., Masterfoods Denmark, Euryza GmbH, Germany., Cerealia R&D, Schulstad Brød A/S, Denmark., Lund University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00324090
Brief Title
Glycemic Index, Body Weight and Health
Official Title
Glycemic Index, Body Weight and Health
Study Type
Interventional
2. Study Status
Record Verification Date
February 2002
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Copenhagen
Collaborators
Danone Vitapole, France., Masterfoods Denmark, Euryza GmbH, Germany., Cerealia R&D, Schulstad Brød A/S, Denmark., Lund University Hospital
4. Oversight
5. Study Description
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.
Detailed Description
Experimental design Two matched groups are given high-GI or low-GI foods to their own diet throughout 10 weeks in a parallel design. A number of measurements are done before, during and at the end of the 10 weeks' intervention.
Subjects A total of 50 slightly overweight (body mass index, BMI = 25-30 kg/m2) women, 20-40 years of age participate. Subjects are randomized according to body weight, composition, age, sex and physical activity level into two matched groups.
A representative subgroup of 15 subjects is randomized from each diet group (a total of 30 subjects) for measurements of energy expenditure and substrate oxidation by ventilated hood as well as postprandial blood sampling.
Experimental diets Subjects eat their own diet until the intervention starts and perform a 7-day weighed dietary record for determination of habitual food intake. At the beginning and every 2 weeks during the 10 weeks' intervention all subjects are instructed in consuming a low-fat (<30 E%), high-carbohydrate diet (>55 E%) by a dietician. Subjects are each week given an amount of carbohydrate-rich foods with either high or low GI with instructions to consume a minimum amount of these every day. We aim at controlling about 75% of the subjects' total carbohydrate intake. The exact amount of test foods eaten is noted every day by the subjects by use of a diary and a diet scale. Instructions in food intake and cooking recipes are given by the dietician. A positive list and a negative list of food items is provided for each study group.
Besides the fixed minimum amount of experimental foods subjects can eat at liberty. Another 7-d dietary record is performed at week 5 and week 10 to register ad libitum food intake. To further validate the dietary records 24-h urine samples are taken during the registrations. Lithium will also be added to the experimental foods in week 4-5 to follow compliance during the study.
Measurements
All subjects:
Week 0, 2, 4, 6, 8, 10 we measured body weight,fat mass and fat-free mass using bio-electrical impedance.In week 0 and 10 we measured body composition by DEXA-scan, W/H-ratio and sagittal height. Blood samples fasting in week 0 and 10 (Glucose, insulin, triacylglycerol (TAG), non-esterified fatty acids (NEFA), leptin, T-cholesterol, LDL-chol, HDL-chol, fructosamine, glycated hemoglobin, GIP, GLP-1, GLP-2, ghrelin, factor VIIc, factor VIIb, PAI-1, Apo A IV.). Blood pressure in week 0 and 10 (fasting systolic and diastolic BP and heart rate). 24-h urine sample is collected in week 0, 5 and 10. Feces is collected in the subgroup in week 0 and 10.
Subgroup:
Week 10: Ventilated hood for measurement of fasting and 4-h postprandial energy expenditure and substrate oxidation. Postprandial appetite scores for hunger, satiety, fullness, prospective consumption, desire for something sweet, fatty. Postprandial blood samples for 4 hours after breakfast (30, 60, 90, 120, 180, 240 min): Glucose, insulin, NEFA, TAG, leptin, glucagon, GIP, GLP-1, GLP-2, ghrelin, paracetamol. At 240 min: factor VIIbt, PAI-1, Apo A IV.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
43 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
High and low glycemic index
Primary Outcome Measure Information:
Title
Body weight
Title
Fat mass and fat-free mass
Title
Food intake
Secondary Outcome Measure Information:
Title
Risk markers for diabetes and CVD
Title
Energy expenditure and substrate oxidation
Title
Appetite
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy, slightly overweight (body mass index, BMI = 25-30 kg/m2) women, premenopausal, non-alcoholic (< 14 units alcohol/w)
Exclusion Criteria:
smoking, elite athletes, food allergies, pregnant, lactating, on medication, blood donation 3 months before, during and 3 months after the completion of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arne Astrup, Prof
Organizational Affiliation
Department of Human Nutrition, Centre for Advanced Food Studies, The Royal Veterinary and Agricultural University, Denmark
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
21775528
Citation
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.
Results Reference
derived
PubMed Identifier
18175742
Citation
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.
Results Reference
derived
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Glycemic Index, Body Weight and Health
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