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low carbohydrate diet for Metabolic Syndrome

Phase 4
Waitlist Available
Led By Sammy Chan, MD
Research Sponsored by St. Paul's Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
presence of metabolic syndrome by International Diabetes Foundation criteria
referral to metabolic syndrome program at St. Paul's Hospital
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 and 6 months
Awards & highlights

Study 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.

Eligible Conditions
  • Metabolic Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
changes in physical activity from baseline
Secondary outcome measures
Change in lipids from baseline
change in renal function from baseline

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: low carbohydrate dietExperimental Treatment1 Intervention
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
Group II: low fat dietActive Control1 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.

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Who is running the clinical trial?

St. Paul's Hospital, CanadaLead Sponsor
44 Previous Clinical Trials
12,648 Total Patients Enrolled
Health CanadaOTHER_GOV
31 Previous Clinical Trials
28,335 Total Patients Enrolled
Sammy Chan, MDPrincipal InvestigatorSt. Paul's Hospital, Vancouver
1 Previous Clinical Trials
250 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~5 spots leftby Mar 2025