Evaluating the efficacy of two types of low-carbohydrate diets on weight, metabolic and inflammatory factors in patients with metabolic syndrome

Phase 2

• Conditions: Metabolic Syndrome.; Obesity due to excess calories

• Registration Number: IRCT2016121925267N4
• Lead Sponsor: Vice chancellor for Research, Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Inclusion criteria consists of: Age between 20 and 50 years old; Diagnosis of metabolic syndrome according to the NCEP-ATPIII criteria (If three or more of the following five criteria are met: Waist circumference over 40 inches (men) or 35 inches (women); Blood pressure over 130/85 mmHg; Fasting triglyceride (TG) level over 150 mg/dl; Fasting high-density lipoprotein (HDL) cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women) and fasting blood sugar over 100 mg/dl). Exclusion criteria are: Alcohol and tobacco consumption; Pregnancy; Lactation; Menopause; History of acute or chronic liver failure; Acute or chronic gastrointestinal diseases, Cholestasis; Diabetes, Kidney disease, Seizure, Autoimmune diseases, Thyroid disorders; Using hormonal drugs such as estrogen, Hormone replacement therapy, Routine consumption of oral contraceptives, Insulin therapy; Malignancy or neoplasia; Routine consumption of antioxidants and vitamin/mineral supplements; Following vegetarian diet or any other special diet in the last 3 months.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Scale.;Body Composition. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Body Impedence Analysis.;Serum Asprosin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;Serum Chemerin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;FGF-21. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;Serum CTRP1. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;Plasma level of Endothelial Microparticles (CD 31,105, 146). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Flowcytometry.;Appetite regulatory hormones (Peptide YY and ghrelin). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.