Saffron effect on pancreatic beta cell pyroptosis in patients with type 2 diabetes

Association between saffron supplementation and metabolic factors, serum oxidative stress indices and gene expression rate of pyroptosis related inflammatory factors in patients with type 2 diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090609002017N24

Enrollment

Registered

2017-12-21

Start date

2017-12-22

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

Type 2 diabetes. Non-insulin dependent diabetes

Interventions

Intervention 1: Saffron powder, 50 mg capsule, 2 per day, for 2 months. Intervention 2: Starch and dextrose powder, 50 mg capsule, 2 per day, for 2 months.

Treatment - Drugs

Placebo

Saffron powder, 50 mg capsule, 2 per day, for 2 months

Starch and dextrose powder, 50 mg capsule, 2 per day, for 2 months

Eligibility

Sex/Gender

All

Age

30 Years to 60 Years

Inclusion criteria

Inclusion criteria: Tendency to attend in study Subjects with T2D Males and females aged 20-60 years BMI 25-35 kg/m2 Not on insulin therapy

Exclusion criteria

Exclusion criteria: Not tendency to attend in study Suffering from chronic inflammatory disorders, renal or hepatic disease Consuming NSAIDs, steroids or hormonal drugs Any change in type or dosage of drugs Any change in diet or physical activity during the running period Smoking Subjects needed to start insulin therapy during intervention Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Expression rate of TLR-4. Timepoint: before and 2 months after the intervention. Method of measurement: RT-PCR.;Expression rate of NLRP3. Timepoint: before and 2 months after the intervention. Method of measurement: RT-PCR.;Expression rate of TXNIP. Timepoint: before and 2 months after the intervention. Method of measurement: RT-PCR.;Expression rate of Caspase-1. Timepoint: before and 2 months after the intervention. Method of measurement: RT-PCR.;Expression rate of IL-1ß. Timepoint: before and 2 months after the intervention. Method of measurement: RT-PCR.;Expression rate of IL-18. Timepoint: before and 2 months after the intervention. Method of measurement: RT-PCR.;Fasting Blood Glucose. Timepoint: before and 2 months after the intervention. Method of measurement: Enzymatic glucose oxidase method.;HOMA-IR. Timepoint: before and 2 months after the intervention. Method of measurement: Estimation base on formula.;Insulin. Timepoint: before and 2 months after the intervention. Method of measurement: ELISA Kit.;HbA1c. Timepoint: before and 2 months after the intervention. Method of measurement: Spectrophotometry.;Malon Dialdehyde. Timepoint: before and 2 months after the intervention. Method of measurement: Spectrophotometry.;Nitric Oxide. Timepoint: before and 2 months after the intervention. Method of measurement: Spectrophotometry.;Total Antioxidan Capacity. Timepoint: before and 2 months after the intervention. Method of measurement: kit.;Catalase. Timepoint: before and 2 months after the intervention. Method of measurement: kit.;Super Oxide Dismutase. Timepoint: before and 2 months after the intervention. Method of measurement: kit.;Glutathion Peroxidase. Timepoint: before and 2 months after the intervention. Method of measurement: kit.;Triglyceride. Timepoint: before and 2 months after the intervention. Method of measurement: Enzymatic method.;HDL-Colesterol. Timepoint: before and 2 months after the intervention. Method of measurement: Enzymatic method.;Total Cho	—

Measure

Time frame

Expression rate of TLR-4. Timepoint: before and 2 months after the intervention. Method of measurement: RT-PCR.;Expression rate of NLRP3. Timepoint: before and 2 months after the intervention. Method of measurement: RT-PCR.;Expression rate of TXNIP. Timepoint: before and 2 months after the intervention. Method of measurement: RT-PCR.;Expression rate of Caspase-1. Timepoint: before and 2 months after the intervention. Method of measurement: RT-PCR.;Expression rate of IL-1ß. Timepoint: before and 2 months after the intervention. Method of measurement: RT-PCR.;Expression rate of IL-18. Timepoint: before and 2 months after the intervention. Method of measurement: RT-PCR.;Fasting Blood Glucose. Timepoint: before and 2 months after the intervention. Method of measurement: Enzymatic glucose oxidase method.;HOMA-IR. Timepoint: before and 2 months after the intervention. Method of measurement: Estimation base on formula.;Insulin. Timepoint: before and 2 months after the intervention. Method of measurement: ELISA Kit.;HbA1c. Timepoint: before and 2 months after the intervention. Method of measurement: Spectrophotometry.;Malon Dialdehyde. Timepoint: before and 2 months after the intervention. Method of measurement: Spectrophotometry.;Nitric Oxide. Timepoint: before and 2 months after the intervention. Method of measurement: Spectrophotometry.;Total Antioxidan Capacity. Timepoint: before and 2 months after the intervention. Method of measurement: kit.;Catalase. Timepoint: before and 2 months after the intervention. Method of measurement: kit.;Super Oxide Dismutase. Timepoint: before and 2 months after the intervention. Method of measurement: kit.;Glutathion Peroxidase. Timepoint: before and 2 months after the intervention. Method of measurement: kit.;Triglyceride. Timepoint: before and 2 months after the intervention. Method of measurement: Enzymatic method.;HDL-Colesterol. Timepoint: before and 2 months after the intervention. Method of measurement: Enzymatic method.;Total Cho

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Secondary

Measure	Time frame
Weight. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: Scale.;Energy and Macro-nutrient intake. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: Questionnaire.;Body Mass Index. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: Estimation.;Waist Circumference. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: mounted tape.;Hip Circumferences. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: mounted tape.;Waist to Hip Ratio. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: Estimation.;Systolic Blood Pressure. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: digital system.;Diastolic Blood Pressure. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: digital system.;Physical activity level. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: Questionnaire.	—

Measure

Time frame

Weight. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: Scale.;Energy and Macro-nutrient intake. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: Questionnaire.;Body Mass Index. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: Estimation.;Waist Circumference. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: mounted tape.;Hip Circumferences. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: mounted tape.;Waist to Hip Ratio. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: Estimation.;Systolic Blood Pressure. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: digital system.;Diastolic Blood Pressure. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: digital system.;Physical activity level. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: Questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAynaz Seyed Tajaddini

Tabriz University of Medical Sciences

tajaddinia@gmail.com+98 41 3331 5579

Outcome results

None listed

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