The effect of lutein on cardiovascular risk factors

The effect of lutein supplementation on anthropometric parameters, metabolic and inflammatory status, sirtuin1 and plasminogen activator inhibitor-1 in obese individuals on a low-calorie diet

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191109045382N1

Enrollment

Registered

2019-12-07

Start date

2020-01-10

Completion date

Unknown

Last updated

2021-05-26

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

Conditions

Cardiovascular diseases, obesity.

Interventions

Intervention group: Patients in this group will receive lutein supplement for 12 weeks. The supplement is a capsule containing 20 milligrams of lutein (a product by Bulk Supplements Co. and made in th

Eligibility

Sex/Gender

All

Age

45 Years to 64 Years

Inclusion criteria

Inclusion criteria: 46 individuals with obesity (BMI of 30-40 kg / m2) Pregnancy, lactation

Exclusion criteria

Exclusion criteria: taking anti-diabetic drugs, statines, or anti-inflammatory drugs developing cardiovascular, renal and hepatic diseases, cancer. bariatrics surgeries

Design outcomes

Primary

Measure	Time frame
Anthropometric Indices. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Measurement of height and weight without shoes and with minimum clothes on, by Seca stadiometer and scale, respectively. Measurement of waist and hip circumference by a tape measure and body mass index (BMI) by dividing weight (kg) by height squared (m2).;Calorie and macronutrients intake. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: The intake of calorie and macronutrients from the diet of the subjects with using a 3 day food record questionnaire and analysis by the nutritionist 4 program.;Fasting blood sugar. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Enzymatic method.;Insulin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA.;Lipid profile. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Measurement of total cholesterol, HDL- cholesterol and triglyceride through enzymatic methods and calculation of LDL- cholesterol by Friedewald equation.;Insulin resistance. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Insulin resistance with HOMA-IR and calculation by this equation : [fasting insulin (mU / ml) × fasting glucose (mg / dl)] / 405.;Inflammatory indices. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Measurement of serum hs-CRP by immunoturbidometry method and serum IL-6 by ELISA.;Free fatty acids. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Chloromerer kit.;Plasminogen activator inhibitor-1. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA.;Sirtuin1. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA.;Endothelin-1. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA.;Nitric oxide. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Chloro	—

Measure

Time frame

Anthropometric Indices. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Measurement of height and weight without shoes and with minimum clothes on, by Seca stadiometer and scale, respectively. Measurement of waist and hip circumference by a tape measure and body mass index (BMI) by dividing weight (kg) by height squared (m2).;Calorie and macronutrients intake. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: The intake of calorie and macronutrients from the diet of the subjects with using a 3 day food record questionnaire and analysis by the nutritionist 4 program.;Fasting blood sugar. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Enzymatic method.;Insulin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA.;Lipid profile. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Measurement of total cholesterol, HDL- cholesterol and triglyceride through enzymatic methods and calculation of LDL- cholesterol by Friedewald equation.;Insulin resistance. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Insulin resistance with HOMA-IR and calculation by this equation : [fasting insulin (mU / ml) × fasting glucose (mg / dl)] / 405.;Inflammatory indices. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Measurement of serum hs-CRP by immunoturbidometry method and serum IL-6 by ELISA.;Free fatty acids. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Chloromerer kit.;Plasminogen activator inhibitor-1. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA.;Sirtuin1. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA.;Endothelin-1. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA.;Nitric oxide. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Chloro

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Zohreh Ghoreyshi

Tabriz University of Medical Sciences

ghoreyshiz@tbzmed.ac.ir+98 41 3336 2117

Outcome results

None listed

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