Effect of Nigella Sativa supplement on the expression of genes involved in insulin resistance

Effect of Nigella Sativa supplement on the expression of genes involved in insulin resistance and inflammation among obese women

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180430039475N1

Enrollment

Registered

2018-06-25

Start date

2018-07-23

Completion date

Unknown

Last updated

2022-05-02

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

Conditions

Obesity. Overweight and obesity

Interventions

Intervention 1: Intervention group: People in this group will recieve two 1000 mg capsules of Nigella Sativa daily for 8 weeks. Then it will be wash out period for 1 month, and after that, people wil

Eligibility

Sex/Gender

Female

Age

25 Years to 55 Years

Inclusion criteria

Inclusion criteria: Obese women with BMI between 27 to 35 kg/m2 Age between 25 to 55 Should not use any drug Should not have diabetes or pre-diabetes or dyslipidemia

Exclusion criteria

Exclusion criteria: People who smoke or drink alcohol Pregnant and nursing women People with chronic kidney, liver disease

Design outcomes

Primary

Measure	Time frame
Expression of genes involved in insulin resistance in peripheral blood mononuclear cells. Timepoint: at the beginning and end of each 2-month intervention period. Method of measurement: Reverse transcription polymerase chain reaction (RT-PCR).;Fasting blood glucose. Timepoint: at the beginning and end of each 2-month intervention period. Method of measurement: Biochemical analysis.;Serum insulin level. Timepoint: at the beginning and end of each 2-month intervention period. Method of measurement: ELISA Kit.;Serum malondialdehyde level. Timepoint: at the beginning and end of each 2-month intervention period. Method of measurement: ELISA kit.;Serum total anti-oxidant capacity. Timepoint: at the beginning and end of each 2-month intervention period. Method of measurement: ELISA kit.;Serum leptin. Timepoint: at the beginning and end of each 2-month intervention period. Method of measurement: ELISA kit.;Serum IL-6. Timepoint: at the beginning and end of each 2-month intervention period. Method of measurement: ELISA kit.	—

Measure

Time frame

Expression of genes involved in insulin resistance in peripheral blood mononuclear cells. Timepoint: at the beginning and end of each 2-month intervention period. Method of measurement: Reverse transcription polymerase chain reaction (RT-PCR).;Fasting blood glucose. Timepoint: at the beginning and end of each 2-month intervention period. Method of measurement: Biochemical analysis.;Serum insulin level. Timepoint: at the beginning and end of each 2-month intervention period. Method of measurement: ELISA Kit.;Serum malondialdehyde level. Timepoint: at the beginning and end of each 2-month intervention period. Method of measurement: ELISA kit.;Serum total anti-oxidant capacity. Timepoint: at the beginning and end of each 2-month intervention period. Method of measurement: ELISA kit.;Serum leptin. Timepoint: at the beginning and end of each 2-month intervention period. Method of measurement: ELISA kit.;Serum IL-6. Timepoint: at the beginning and end of each 2-month intervention period. Method of measurement: ELISA kit.

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Secondary

Measure	Time frame
Dietary intake. Timepoint: At the beginning and end of each 2-month intervention period. Method of measurement: three-day food records and 24-h food recalls questionnaires.;Expression of hormone-related genes in peripheral blood mononuclear cells. Timepoint: at the beginning and end of each 2-month intervention period. Method of measurement: Reverse transcription polymerase chain reaction (RT-PCR).;Serum level of estradiol. Timepoint: at the beginning and end of each 2-month intervention period. Method of measurement: ELISA kit.;Serum level of sex-hormone binding globulin. Timepoint: at the beginning and end of each 2-month intervention period. Method of measurement: ELISA kit.	—

Measure

Time frame

Dietary intake. Timepoint: At the beginning and end of each 2-month intervention period. Method of measurement: three-day food records and 24-h food recalls questionnaires.;Expression of hormone-related genes in peripheral blood mononuclear cells. Timepoint: at the beginning and end of each 2-month intervention period. Method of measurement: Reverse transcription polymerase chain reaction (RT-PCR).;Serum level of estradiol. Timepoint: at the beginning and end of each 2-month intervention period. Method of measurement: ELISA kit.;Serum level of sex-hormone binding globulin. Timepoint: at the beginning and end of each 2-month intervention period. Method of measurement: ELISA kit.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSara Safi Esfahani

Yazd University of Medical Sciences

drsafi@ssu.ac.ir+98 35 3820 9100

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 13, 2026