The effect of synbiotic supplementation on patients with metabolic syndrome

The effect of synbiotic supplementation on glycemic indices, inflammatory biomarkers, and appetite in patients with metabolic syndrome, an approach to prevent cardiovascular disease

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20140208016529N4

Enrollment

Registered

2020-02-01

Start date

2019-12-14

Completion date

Unknown

Last updated

2020-02-24

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

Conditions

Metabolic syndrome. Metabolic disorder, unspecified

Interventions

Intervention 1: Intervention group: Synbiotic Supplement, as 500 mg capsule, twice a day orally, for 8 weeks. Intervention 2: Control group: Placebo (as 500 mg capsule, maltodexterin), quite simila

Eligibility

Sex/Gender

All

Age

20 Years to 55 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Willingness to participate in projects Women and men aged 20-55 years Waist circumference =88 cm in women and waist circumference =102 cm in men, serum triglyceride =150 mg/dl, serum HDL cholesterol 25 kg/m2

Exclusion criteria

Exclusion criteria: History of mental disease, cancer, cardiovascular disease, thyroid, pulmonary,renal and hepatic problems and eating disorders Pregnant,lactating and post-menopausal women Participating in weight loss or weight gain programs three months before the intervention Taking any dietary supplements, probiotics, prebiotic, synbiotic food products, and antibiotics two months before the intervention Taking drugs that affect appetite and body weight,and anti-inflammatory drugs History of allergies to probiotics , prebiotics and maltodextrin products

Design outcomes

Primary

Measure	Time frame
Fasting Blood Sugar. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Colorimetric method.;Serum insulin. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: ELISA.;Homeostasis model assessment of insulin resistance (HOMA-IR). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Equation.;Quantitative Insulin Sensitivity Check Index(QUICKI). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Equation.	—

Measure

Time frame

Fasting Blood Sugar. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Colorimetric method.;Serum insulin. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: ELISA.;Homeostasis model assessment of insulin resistance (HOMA-IR). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Equation.;Quantitative Insulin Sensitivity Check Index(QUICKI). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Equation.

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Secondary

Measure	Time frame
High Sensitivity C-Reactive Protein. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Biochemical method.;Tumor Necrosis Factor-Alpha (TNF-a). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: ELISA.;Appetite. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Visual Analogue Scale.;Energy content of food. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Food record questionnaire.;Physical activity energy expenditure. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Metabolic equivalent of tasks questionnaire.	—

Measure

Time frame

High Sensitivity C-Reactive Protein. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Biochemical method.;Tumor Necrosis Factor-Alpha (TNF-a). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: ELISA.;Appetite. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Visual Analogue Scale.;Energy content of food. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Food record questionnaire.;Physical activity energy expenditure. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Metabolic equivalent of tasks questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Hasan Entezari

Esfahan University of Medical Sciences

entezari@hlth.mui.ac.ir+98 31 3668 1378

Outcome results

None listed

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