Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324090
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2006-05-09
Brief Title:
Glycemic Index Body Weight and Health
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
Official Title:
Glycemic Index Body Weight and Health
Status:
COMPLETED
Status Verified Date:
2002-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 kgm2 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 weightfat mass and fat-free mass using bio-electrical impedanceIn week 0 and 10 we measured body composition by DEXA-scan WH-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
Subjects A total of 50 slightly overweight body mass index BMI 25-30 kgm2 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 weightfat mass and fat-free mass using bio-electrical impedanceIn week 0 and 10 we measured body composition by DEXA-scan WH-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| B184 | None | None | None |