Weight Loss and Changes in Cardiovascular Risk Markers With a Low Glycemic Diet Compared With a Standard Diet
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|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|
- 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.
- Compare the consequences of the two strategies with respect to 3, 6, and 12 months development of the variables; glucose/insulin,
- insulin sensitivity index,
- number of metabolic syndrome factors,
- high sensitive C-reactive protein,
- lipids and lipoprotein B and
- anthropometric indices (waist /hip ratio)
- Fat cell hormones (leptin, adiponectin, ghrelin)
- Inflammation markers (ICAM).
- Weight at 18 months follow-up.
|Study Start Date:||April 2004|
|Study Completion Date:||November 2006|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
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 1,3,4,5,6 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 1,4. A 500 kcal/day 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 glucose/insulin, 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00230919
|Ulleval University Hospital, dep. of preventive cardiology|
|Oslo, Norway, N-0407|
|Principal Investigator:||Tor Ole Klemsdal, MD, Ph.D||Ullevaal University Hospital, preventive medicine clinic|
|Study Chair:||Serena Tonstad, MD, Ph.D||Ullevaal University Hospital, preventive medicine clinic|