The ACT-OUT Trial: ACTivity OUTcomes Based on High Carbohydrate or High Fat Diet in Metabolic Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01357382|
Recruitment Status : Unknown
Verified April 2011 by St. Paul's Hospital, Canada.
Recruitment status was: Not yet recruiting
First Posted : May 20, 2011
Last Update Posted : May 20, 2011
Current obesity prevention emphasizes caloric restriction and avoidance of high fat foods. The result is an approach that replaces dietary fat with carbohydrates. There has, however, since been an obesity epidemic with an increased prevalence of metabolic syndrome (MetS) and type II diabetes. Negative results from trials of low fat diets for weight loss, prevention of heart disease and malignancies are consistent with the inadequacy of low fat/high carbohydrate approach. One of the findings of trials comparing low fat, calorie reduced diets to ad lib carbohydrate restricted diets is that subjects randomized to a low carbohydrate intake lose more weight despite equivalent intake. This equates to a 200 kcal/day greater weight loss on a carbohydrate restricted diet. Some investigators have speculated the metabolic advantage of carbohydrate restriction is due to increased energetic costs of gluconeogenesis. Alternatively, carbohydrate restriction is associated with increases in spontaneous physical activity.
This protocol has three aims. First, adherence to a carbohydrate restricted diet in subjects with metabolic syndrome will cause an increase in spontaneous physical activity, independent of weight changes. Second, cardiometabolic risk factors (ApoB, TG, HDL, blood pressure, CRP) will show greater improvement on a carbohydrate restricted diet compared to a low-fat, high carbohydrate diet. Finally the investigators will interview a sub-sample of participants to better understand quality of life issues with respect to the dietary assignment or lifestyle intervention.
The investigators will recruit 72 participants with MetS, from the Metabolic Syndrome Program at St. Paul's Hospital, Vancouver. Individuals will be randomized to either a low-carbohydrate diet or a calorie restricted, low fat diet and followed for 6 months. The investigators will measure body composition with bioelectrical impedance at baseline, 3 and 6 months. The investigators will also examine cardiometabolic changes due to the standard lifestyle intervention compared to the carbohydrate restricted treatment. The investigators will examine blood pressure, triglycerides, LDL-chol, HDL-chol, C-reactive protein, apolipoprotein B, glucose, insulin, hemoglobin A1c and leptin at baseline, 3 and 6 months. The investigators will use accelerometers to assess changes in physical activity. The investigators will use three-way repeated-measures ANOVA, with changes in body weight and insulin levels as covariates in the model with time as the repeated factor for statistical analyses.
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Other: Low carbohydrate diet||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The ACT-OUT Trial: ACTivity OUTcomes Based on the Consumption of a High Carbohydrate or High Fat Diet in Patients With Metabolic Syndrome|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||May 2012|
|Estimated Study Completion Date :||July 2012|
No Intervention: low fat diet
replace high fat, energy dense foods with foods rich in whole grains, fruits and vegetables. The macronutrient distribution of this diet will be approximately 55% carbohydrate, 15% protein and 30% fat. Individuals will also be instructed to reduce sodium intake to < 2300 mg / day and in individuals with hypertension, < 1500 mg / day.
Experimental: low carbohydrate diet
restrict carbohydrate consumption to < 20 grams / day while not restricting caloric intake. Participants will be encouraged to consume vegetables with low carbohydrate content every day including 2 cups of salad greens and 1 cup of vegetables 'that grow above the ground' to increase their salt intake by consuming two cups of broth , ½ teaspoon of salt, or tablespoons of salt daily
Other: Low carbohydrate diet
restrict carbohydrate consumption to < 20 grams / day while not restricting their caloric intake. Participants will be encouraged to consume vegetables with low carbohydrate content every day including 2 cups of salad greens and 1 cup of vegetables 'that grow above the ground' increase their salt intake by consuming two cups of broth , ½ teaspoon of salt, or tablespoons of salt daily
- changes in physical activity from baseline [ Time Frame: 3 and 6 months ]
- activity counts per minute;
- time spent in light and moderate to vigorous physical activity;
- activity based energy expenditure using previously validated equations
- Change in lipids from baseline [ Time Frame: 3 and 6 months ]total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, apolipoprotein B, apolipoprotein A1
- change in renal function from baseline [ Time Frame: 3 and 6 months ]creatinine, urine microalbumin/creatinine ratio, serum and urine NGAL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357382
|Contact: Sean Mark, Ph.Demail@example.com|
|Contact: Luba Cermakova||604 firstname.lastname@example.org|
|Canada, British Columbia|
|St. Paul's Hospital||Not yet recruiting|
|Vancouver, British Columbia, Canada, V6Z1Y6|
|Principal Investigator:||Sammy Chan, MD||St. Paul's Hospital, Vancouver|