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| Name | Class |
|---|---|
| Norges Forskningsråd, Stenberggata 26, pb. 2700, N-0131 Oslo, Norway | UNKNOWN |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet counseling | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the consequences of the two strategies with respect to 3, 6, and 12 months development of the variables; glucose/insulin, | ||
| insulin sensitivity index, | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tor Ole Klemsdal, MD, Ph.D | Ullevaal University Hospital, preventive medicine clinic | Principal Investigator |
| Serena Tonstad, MD, Ph.D | Ullevaal University Hospital, preventive medicine clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulleval University Hospital, dep. of preventive cardiology | Oslo | Oslo | N-0407 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19502017 | Result | Klemsdal TO, Holme I, Nerland H, Pedersen TR, Tonstad S. Effects of a low glycemic load diet versus a low-fat diet in subjects with and without the metabolic syndrome. Nutr Metab Cardiovasc Dis. 2010 Mar;20(3):195-201. doi: 10.1016/j.numecd.2009.03.010. Epub 2009 Jun 6. | |
| 22889406 | Derived | Heggen E, Klemsdal TO, Haugen F, Holme I, Tonstad S. Effect of a low-fat versus a low-gycemic-load diet on inflammatory biomarker and adipokine concentrations. Metab Syndr Relat Disord. 2012 Dec;10(6):437-42. doi: 10.1089/met.2012.0012. Epub 2012 Aug 13. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001836 | Body Weight Changes |