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The effect of probiotics and curcumin in patients with type 2 diabetes

"The effect of probiotics and curcumin on glycemic and insulin status and oxidative stress in patients with type 2 diabetes: a triple-blind clinical trial"

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191105045340N7
Enrollment
92
Registered
2025-07-22
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-08-19

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

Conditions

Type 2 diabetes. Type 2 diabetes mellitus

Interventions

Intervention 1: Intervention group: They receive one daily probiotic supplement capsule with a dose of 109 CFU (Zist Fermentation Company) (Food and Drug Supplement IRCT code: 5299398045382901) along
. Intervention 2: Intervention group: They take one 500 mg capsule of curcumin (Karen Company) (IRCT code is 1058067011726337) daily along with a probiotic supplement
. Intervention 3: Intervention group: They receive one probiotic capsule daily along with one 500 mg curcumin capsule. Intervention 4: Control group: Will receive placebo for both supplements.

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age: Patients between 30 and 65 years. Diagnosis of type 2 diabetes: Patients with type 2 diabetes who have had the disease for at least 6 months and have been confirmed by an endocrinologist Body mass index (BMI) in the range of 25 to 35 kg/m2.4. HbA1C range between 6.5% and 9% No supplements: No use of vitamin, mineral or antioxidant supplements and pro- and pre-supplements in the past month. Stable medical condition: Patients who have a stable medical condition and their main medications have not changed in the past month.

Exclusion criteria

Exclusion criteria: Comorbidities: Severe renal, hepatic, cardiovascular, cancer, or other disorders. Insulin injections Pregnant or breastfeeding women. Allergy to interventions: History of allergy to probiotics, turmeric, or curcumin. Occurrence of digestive problems due to the intervention (including reflux) Use of antibiotics in the 14 days prior to the start of the intervention Unwillingness to continue the study: voluntary withdrawal of the patient or failure to cooperate in taking supplements or providing samples.

Design outcomes

Primary

MeasureTime frame
Fasting blood sugar (FBS) level. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Blood test.;Serum insulin. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Blood test.

Secondary

MeasureTime frame
Malondialdehyde level. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Blood test.;Total antioxidant capacity (TAC). Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Blood test.;HbA1c. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Blood test.;Homeostatic insulin resistance index (HOMA-IR). Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Calculated from fasting glucose and insulin levels using the formula (Fasting Glucose (mg/dL) * Fasting Insulin (mU/L)) / 405.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyedeh Tayebeh Rahideh

Iran University of Medical Sciences

rahide.t@iums.ac.ir+98 21 8670 4843

Outcome results

None listed

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