Effect of L-arginine and selenium supplementation on metabolic syndrome components in obese women with hypocaloric diet enriched in legumes

Phase 3

Conditions: Condition 1: metabolic syndrome. Condition 2: obesity.
Metabolic disorder, unspecified
obesity

Registration Number: IRCT138712101720N1

Lead Sponsor: Tabriz university of medical sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 85

Inclusion Criteria

premenopausal women aged 20 -50 y, with waist circumference higher than 88 cm, who have not participated in weight-reduction programs, and have maintained a stable weight (±1 kg) during the last 6 months.
Exclusion criteria: any secondary cause of hyperglycemia (as trauma) or hypertension (as renal disease); treatment with insulin or oral hypoglycemic agents, antihypertensive or antilipemic agents; take any vitamin or mineral supplements, nitrate, arginine, selenium or antiacids containing magnesium or calcium; untreated hypothyroidism; cancer or systemic, hepatic, pulmonary, cardiovascular or renal disease; psychiatric disorders, presence of inflammatory or infectious disease; smoking; alcoholism and legumes intolerance.

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anthropometric indicators: weight, height, body mass index, waist circumference, hip circumference and waist to hip ratio. Timepoint: Each 3 weeks: baseline, midpoint, endpoint. Method of measurement: Standard procedures using scale, tape and equations.;Metabolic syndrome components:waist circumference, FBS, HDL, TG, hypertension. Timepoint: Each 3 weeks: baseline, midpoint, endpoint. Method of measurement: tape (waist circumference), kit and autoanalyzer (FBS,HDL,TG) and sphygmomanometer(blood pressure), respectively.

Secondary Outcome Measures

Name	Time	Method
Insulin resistance: Insulin, HOMA-IR index. Timepoint: Each 3 weeks: baseline, midpoint, endpoint. Method of measurement: elisa and formula.;Non-alcoholic fatty liver disease indicators: alanine and aspartate aminotransferase. Timepoint: Each 3 weeks: baseline, midpoint, endpoint. Method of measurement: kit and outoanalyser.;Hs-CRP. Timepoint: Each 3 weeks: baseline, midpoint, endpoint. Method of measurement: immunoturbidimetry.;Malondialdehyde. Timepoint: Each 3 weeks: baseline, midpoint, endpoint. Method of measurement: thiobarbituric acid method.;NOx. Timepoint: Each 3 weeks: baseline, midpoint, endpoint. Method of measurement: colormetry (Griess reaction).