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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT138712101720N1

Enrollment

Registered

2009-05-02

Start date

2008-12-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention 1: Intervention groups: isocaloric diet (55% CHO, 30% FAT and 15% PRO) for 2 weeks in run-in period and hypocaloric diet enriched in legumes (55% CHO, 30% FAT and 15% PRO) supplemented wi

Lifestyle

Intervention groups: isocaloric diet (55% CHO, 30% FAT and 15% PRO) for 2 weeks in run-in period and hypocaloric diet enriched in legumes (55% CHO, 30% FAT and 15% PRO) supplemented with arginine+plac

Control groups: isocaloric diet (55% CHO, 30% FAT and 15% PRO) for 2 weeks in run-in period and hypocaloric diet (55% CHO, 30% FAT and 15% PRO) enriched in legumes or without legumes with placebo of a

Eligibility

Sex/Gender

Female

Age

20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Alizadeh

School of health and nutrition, Tabriz university of mdical sciences

alizadehmo@tbzmed.ac.ir alizade85@yahoo.com+98 41 1668 7715

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026