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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
University of Copenhagen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight

Eligibility Criteria

20 Years - 41 Years (Adult)FemaleAccepts Healthy Volunteers

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

    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
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    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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