Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230919
Status:
COMPLETED
Last Update Posted:
2011-07-01
First Post:
2005-09-30
Brief Title:
Weight Loss and Changes in Cardiovascular Risk Markers With a Low Glycemic Diet Compared With a Standard Diet
Sponsor:
Ullevaal University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Weight Loss and Changes in Cardiovascular Risk Markers With a Low Glycemic Load Diet Compared With a Standard National Nutrition Council-recommended Diet a Randomized Trial
Status:
COMPLETED
Status Verified Date:
2004-02
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:
Overweight and obesity is increasing in most countries including Norway and the optimal diet for reducing weight is under discussion The present study in overweight and moderate obese individuals compares a low glycemic load diet with a standard low-fat diet as recommended from the National Nutrition Council in an open randomized trial over 12 months with changes in weight loss and changes in cardiovascular risk markers as endpoints
Detailed Description:
Overweight and obesity is rapidly increasing in most countries including Norway and at present there is controversy regarding what diet should be recommended for reducing weight and the complications of obesity
The present study is performed in in 200 overweight and moderate obese individuals that is in men with body mass index BMI from 28 to 40 and women with BMI 28-35 To be included the participants should also have at least one component of the metabolic syndrome
After a medical examination and check for inclusion and exclusion criteria the participants are randomized to one the two following diets 1 A low-glycemic load diet aiming at a macronutrient composition with 25-30 of energy from protein 35-40 from fat and 30-35 from carbohydrate or 2 A low-fat diet aiming at a macronutrient composition with 15 of energy from protein 25-30 from fat and 55-60 from carbohydrate
Each group will have 9 dietary counselling sessions in the course of the study baseline week 2 month 13456 and 9 Recommended total energy intake will be individualized based on the metabolic rate at rest for each subject and using a physical activity level of 14 A 500 kcalday deficit relative to the daily energy requirements will be recommended
The primary objective will be to compare the effects of the two different diet recommendations with respect to the one-year change in body weight
As secondary objectives the study will compare the consequences of the two strategies with respect to 3 6 and 12 months development of the variables glucoseinsulin insulin sensitivity index number of metabolic syndrome factors high sensitive C-reactive protein lipids lipoprotein B and anthropometric indices waist hip ratio Serum will be frozen for additional parameters as leptin adiponectin ghrelin and ICAM Also to be studied is an additional weight at 18 months follow-up when no more advice is given past the 9-month visit
The present study is performed in in 200 overweight and moderate obese individuals that is in men with body mass index BMI from 28 to 40 and women with BMI 28-35 To be included the participants should also have at least one component of the metabolic syndrome
After a medical examination and check for inclusion and exclusion criteria the participants are randomized to one the two following diets 1 A low-glycemic load diet aiming at a macronutrient composition with 25-30 of energy from protein 35-40 from fat and 30-35 from carbohydrate or 2 A low-fat diet aiming at a macronutrient composition with 15 of energy from protein 25-30 from fat and 55-60 from carbohydrate
Each group will have 9 dietary counselling sessions in the course of the study baseline week 2 month 13456 and 9 Recommended total energy intake will be individualized based on the metabolic rate at rest for each subject and using a physical activity level of 14 A 500 kcalday deficit relative to the daily energy requirements will be recommended
The primary objective will be to compare the effects of the two different diet recommendations with respect to the one-year change in body weight
As secondary objectives the study will compare the consequences of the two strategies with respect to 3 6 and 12 months development of the variables glucoseinsulin insulin sensitivity index number of metabolic syndrome factors high sensitive C-reactive protein lipids lipoprotein B and anthropometric indices waist hip ratio Serum will be frozen for additional parameters as leptin adiponectin ghrelin and ICAM Also to be studied is an additional weight at 18 months follow-up when no more advice is given past the 9-month visit
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