Status:
COMPLETED
Weight Loss and Changes in Cardiovascular Risk Markers With a Low Glycemic Diet Compared With a Standard Diet
Lead Sponsor:
Ullevaal University Hospital
Collaborating Sponsors:
Norges Forskningsråd, Stenberggata 26, pb. 2700, N-0131 Oslo, Norway
Conditions:
Obesity
Metabolic Syndrome
Eligibility:
All Genders
30-65 years
Phase:
NA
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 c...
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 complication...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00230919
Start Date
April 1 2004
End Date
November 1 2006
Last Update
July 1 2011
Active Locations (1)
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1
Ulleval University Hospital, dep. of preventive cardiology
Oslo, Oslo County, Norway, N-0407