Investigating the effect Functional Edible Powder Enriched with Probiotics, Curcumin, or Their Combination on Some Inflammatory Markers, Fasting Blood Glucose, and Blood Pressure in Overweight or Obese Individuals with Metabolic Syndrome

Assessing the effect of Functional Edible Powder Enriched with Probiotics, Curcumin, or Their Combination on Some Inflammatory Markers, Fasting Blood Glucose, and Blood Pressure in Overweight or Obese Individuals with Metabolic Syndrome: a Randomized, double-blind, controlled clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220315054289N1

Enrollment

128

Registered

2022-04-01

Start date

2022-06-22

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

Metabolic syndrome. Metabolic syndrome

Interventions

Intervention 1: Intervention group 1: Dissolve and receive curcumin-enriched edible functional powder containing 1000 mg of curcumin (Karen Pharma and Food Supplement Co.) in water daily for 8 weeks.

Eligibility

Sex/Gender

All

Age

30 Years to 65 Years

Inclusion criteria

Inclusion criteria: Aged 30 - 65 years Overweight (BMI between 25 to 29.9) or obese (BMI over 30) individuals with metabolic syndrome based on ATP III criteria Not suffering from metabolic, endocrine, or cardiovascular disease (except diabetes, dyslipidemia, and hypertension) at baseline Not suffering from kidney, liver, or systemic diseases at the beginning of the study Not infected with Covid-19 or any other infections for 3 months before the study No history of hospitalization for 3 months prior to the study Has not used antibiotics for 3 months before beginning the study Has not taken curcumin and probiotic supplements, any drugs or supplements for 3 months before the study

Exclusion criteria

Exclusion criteria: Pregnancy Lactating Suffering from components of the metabolic syndrome (diabetes, hypertension, or dyslipidemia) that require drug treatment

Design outcomes

Primary

Measure	Time frame
Tumor necrosis factor alpha (TNF-a) blood level. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme-linked immuno_sorbent assay (ELISA).;Interleukin 6 (IL-6) blood level. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme-linked immuno_sorbent assay (ELISA).;High-sensitivity C-reactive Protein (hs-CRP) blood level. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme-linked immuno_sorbent assay (ELISA).	—

Measure

Time frame

Tumor necrosis factor alpha (TNF-a) blood level. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme-linked immuno_sorbent assay (ELISA).;Interleukin 6 (IL-6) blood level. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme-linked immuno_sorbent assay (ELISA).;High-sensitivity C-reactive Protein (hs-CRP) blood level. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme-linked immuno_sorbent assay (ELISA).

—

Secondary

Measure	Time frame
Fasting blood glucose. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Standard enzymatic method.;Systolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Sphygmomanometer.;Diastolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Sphygmomanometer.	—

Measure

Time frame

Fasting blood glucose. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Standard enzymatic method.;Systolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Sphygmomanometer.;Diastolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Sphygmomanometer.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Ali Mohsenpour

Shiraz University of Medical Sciences

mohammadali.mohsenpour@gmail.com+98 71 3725 8099

Outcome results

None listed

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