The ACT-OUT Trial: ACTivity OUTcomes Based on High Carbohydrate or High Fat Diet in Metabolic Syndrome

NCT01357382 | Unknown Phase 4

• 1 other identifier: H10-02652
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome

Keywords

low fat diet; low carbohydrate diet

Outcome Measures

Primary Outcomes (1)

• changes in physical activity from baseline

  1. activity counts per minute; 2. time spent in light and moderate to vigorous physical activity; 3. activity based energy expenditure using previously validated equations

  3 and 6 months

Secondary Outcomes (2)

• Change in lipids from baseline

  3 and 6 months

• change in renal function from baseline

  3 and 6 months

Study Arms (2)

low fat diet

NO INTERVENTION

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.

low carbohydrate diet

EXPERIMENTAL

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

Interventions

Low carbohydrate diet OTHER

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

low carbohydrate diet

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presence of metabolic syndrome by International Diabetes Foundation criteria
• referral to metabolic syndrome program at St. Paul's Hospital
• age \> 19 years

You may not qualify if:

• unwillingness to participate in research study
• unwillingness to comply with dietary intervention
• following a weight reducing diet
• abusing alcohol or other psychoactive substances
• on psychiatric medication associated with weight gain
• plans to travel during the study period
• food allergies or intolerances that will interfere with their adherence to either of the study diets

Sponsors & Collaborators

• St. Paul's Hospital, Canada: lead
• Health Canada: collaborator

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Sammy Chan, MD

  St. Paul's Hospital, Vancouver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sean Mark, Ph.D

CONTACT

sean.mark@hc-sc.gc.ca

Luba Cermakova

CONTACT

604 8069624; lcermakova@providencehealth.bc.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 13, 2011
• First Posted: May 20, 2011
• Study Start: June 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 20, 2011

Record last verified: 2011-04

Locations

CA (1)