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Investigating the effectiveness of synbiotic supplementation on improving metabolic parameters in children with cardiometabolic syndrome: A randomized clinical trial

Investigating the effectiveness of synbiotic supplementation on improving metabolic parameters in children with cardiometabolic syndrome: A randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220409054467N4
Enrollment
64
Registered
2025-07-04
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Cardiometabolic syndrome. Metabolic syndrome

Interventions

Intervention 1: Intervention group: The intervention group will consume 1 synbiotic capsule daily for 12 weeks. Each capsule will contain a specific dose of probiotics (equivalent to 10^9 CFU of each

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 18 Years

Inclusion criteria

Inclusion criteria: Willingness to cooperate and sign the informed consent form after full knowledge of the objectives and methods of the study. Girls and boys aged 5 to 18 years. Diagnosis of cardiometabolic syndrome based on common criteria (presence of at least three of the following: central obesity, insulin resistance, high blood pressure, blood lipid disorders). Absence of acute or chronic gastrointestinal diseases that may affect the composition of the gut microbiome. No substance abuse, no hormone therapy, no recent weight loss diet. No pregnancy or breastfeeding in women. Do not take medications or supplements that affect appetite, weight, or metabolism for at least 6 months before the study (such as medications that affect carbohydrate, protein, or fat metabolism, and medications that reduce or increase appetite or food intake, including herbal supplements). No history of gastrointestinal surgery. Avoid concomitant use of metabolism-related medications or probiotics, such as antibiotics.

Exclusion criteria

Exclusion criteria: Having any acute illness. The occurrence of any accident that affects a person's health. Acceptance rate less than 80%. Immigration. Exclusion based on personal preference of participants or their parents. Changes in medications taken during the study period.

Design outcomes

Primary

MeasureTime frame
Weight. Timepoint: Beginning and end of the study. Method of measurement: scale.;Serum glucose levels. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit.;Serum triglyceride level. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit.

Secondary

MeasureTime frame
Body mass index. Timepoint: Beginning and end of the study. Method of measurement: Calculation.;Serum C-Reactive Protein (CRP) levels. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit.;Systolic blood pressure. Timepoint: Beginning and end of the study. Method of measurement: blood pressure monitor.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPejman Rohani

Tehran University of Medical Sciences

cmcpr@tums.ac.ir+98 21 6693 0024

Outcome results

None listed

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