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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by St. Paul's Hospital, Canada.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Health Canada
Information provided by:
St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01357382
First received: May 13, 2011
Last updated: May 19, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Metabolic Syndrome
Other: Low carbohydrate diet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by St. Paul's Hospital, Canada:

Primary Outcome Measures:
  • changes in physical activity from baseline [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Change in lipids from baseline [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, apolipoprotein B, apolipoprotein A1

  • change in renal function from baseline [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    creatinine, urine microalbumin/creatinine ratio, serum and urine NGAL


Estimated Enrollment: 72
Study Start Date: June 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357382

Contacts
Contact: Sean Mark, Ph.D sean.mark@hc-sc.gc.ca
Contact: Luba Cermakova 604 8069624 lcermakova@providencehealth.bc.ca

Locations
Canada, British Columbia
St. Paul's Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V6Z1Y6
Sponsors and Collaborators
St. Paul's Hospital, Canada
Health Canada
Investigators
Principal Investigator: Sammy Chan, MD St. Paul's Hospital, Vancouver
  More Information

Additional Information:
No publications provided

Responsible Party: Sammy Chan, Healthy Heart Program, St. Paul's Hospital
ClinicalTrials.gov Identifier: NCT01357382     History of Changes
Other Study ID Numbers: H10-02652
Study First Received: May 13, 2011
Last Updated: May 19, 2011
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by St. Paul's Hospital, Canada:
low fat diet
low carbohydrate diet

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 20, 2014