Weight Loss and Changes in Cardiovascular Risk Markers With a Low Glycemic Diet Compared With a Standard Diet

This study has been completed.
Sponsor:
Collaborator:
Norges Forskningsråd, Stenberggata 26, pb. 2700, N-0131 Oslo, Norway
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00230919
First received: September 30, 2005
Last updated: June 30, 2011
Last verified: February 2004
  Purpose

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.


Condition Intervention
Obesity
Metabolic Syndrome
Behavioral: Diet counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Compare the consequences of the two strategies with respect to 3, 6, and 12 months development of the variables; glucose/insulin, [ Designated as safety issue: No ]
  • insulin sensitivity index, [ Designated as safety issue: No ]
  • number of metabolic syndrome factors, [ Designated as safety issue: No ]
  • high sensitive C-reactive protein, [ Designated as safety issue: No ]
  • lipids and lipoprotein B and
  • anthropometric indices (waist /hip ratio) [ Designated as safety issue: No ]
  • Fat cell hormones (leptin, adiponectin, ghrelin) [ Designated as safety issue: No ]
  • Inflammation markers (ICAM). [ Designated as safety issue: No ]
  • Weight at 18 months follow-up. [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2004
Study Completion Date: November 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women age 30-65,
  • BMI in the range 28-35 kg/m2 for women and 28-40kg/m2 for men.
  • At least one of the following components of the metabolic syndrome; fasting triglycerides > 1,7, fasting glucose 6,0-6,9, HDL-cholesterol <1,03 (males) or <1,29 (females), Blood pressure >130/85 (with or without treatment), diet-treated diabetes mellitus or drug treated hypertension.
  • Stable weight range of 4 kg or less the last 12 weeks,
  • No major change in physical activity the last 12 weeks

Exclusion Criteria:

  • Any symptomatic cardiovascular disease
  • Diabetes requiring drug treatment
  • Currently on special diet
  • Hepatic/renal dysfunction
  • Hypothyroidism (unstable)
  • GI disorder impairing compliance with diet recommendation,
  • History of unstable psychiatric or medical disorder,
  • Need of lipid lowering drug,
  • Alcohol or drug abuse,
  • Participation in drug trial the last 30 days,
  • Use of drugs for weight reduction last 12 weeks, pregnancy or planned pregnancy,
  • Obesity of known endocrine origin, history of obesity surgery,
  • Uncontrolled hypertension (>160/100),
  • Previous participation in >3 weight reduction programs, or within last 12 months,
  • Not willing to be randomized,
  • Individual judged to be unable to follow instructions and procedures of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230919

Locations
Norway
Ulleval University Hospital, dep. of preventive cardiology
Oslo, Norway, N-0407
Sponsors and Collaborators
Ullevaal University Hospital
Norges Forskningsråd, Stenberggata 26, pb. 2700, N-0131 Oslo, Norway
Investigators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of preventive Cardiology, Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00230919     History of Changes
Other Study ID Numbers: 161327/V50
Study First Received: September 30, 2005
Last Updated: June 30, 2011
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
Obesity,
weight loss,
diet counseling
low-glycemic load

Additional relevant MeSH terms:
Obesity
Metabolic Syndrome X
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Body Weight Changes

ClinicalTrials.gov processed this record on September 18, 2014