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Chromium picolinate in metabolic dysfunction-associated steatotic liver disease

The effect of chromium picolinate supplementation on insulin resistance, liver enzymes, steatosis and fibrosis in individuals with normal weight and metabolic dysfunction-associated steatotic liver disease: A parallel double-blind randomized controlled clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250222064808N1
Enrollment
80
Registered
2025-04-13
Start date
2025-06-22
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

Metabolic dysfunction–associated steatotic liver disease. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: Intervention group: Patients in this group will receive chromium picolinate tablets including 500 mcg chromium once a day for 12 weeks. Tablets are made in Iran. Intervention 2: Contro

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Adults (male and female) in the age range of 18-65 years Have a body mass index of 18.5 to 25 Diagnosis of MASLD based on fibroscan by a gastroenterologist and in the range (7.3-17.6 kPa for fibrosis and greater than 238 dB/m for steatosis)

Exclusion criteria

Exclusion criteria: Alcohol consumption Pregnant or lactating females Having other liver diseases (including hepatitis B and C), biliary diseases, autoimmune diseases, cancer, kidney diseases, thyroid diseases, and diabetes Use of blood sugar-lowering drugs and insulin Use of medications that affect liver fat, corticosteroids, antibiotics, hepatotoxic medications, and levothyroxine Weight loss in the last 3 months Withdrawal from study follow-up Weight loss more than 10% during the study Pregnancy during study The occurrence of any severe gastrointestinal complications related to the intervention (headache, diarrhea, vomiting, abdominal pain)

Design outcomes

Primary

MeasureTime frame
Changes in liver steatosis. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (after 12 weeks of intervention). Method of measurement: Fibroscan.

Secondary

MeasureTime frame
Liver fibrosis. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study ( after 12 weeks of intervention). Method of measurement: Fibroscan.;Fasting blood sugar. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (after 12 weeks of intervention). Method of measurement: Glucose oxidase.;Serum insulin. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (after 12 weeks of intervention). Method of measurement: Elisa kit.;HOMA-IR. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (after 12 weeks of intervention). Method of measurement: Formula: HOMA-IR = (fasting insulin (µU/L) × fasting glucose (mmol/L))/22.5.;QUICKI. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (after 12 weeks of intervention). Method of measurement: Formula: QUICKI= 1 / (log (fasting insulin µU/mL) + log (fasting glucose mg/dL)).;Alanine transaminase (ALT). Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (after 12 weeks of intervention). Method of measurement: Colorimetric determination.;Aspartate transaminase (AST). Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (after 12 weeks of intervention). Method of measurement: Colorimetric determination.;Gamma-glutamyl transferase (GGT). Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (after 12 weeks of intervention). Method of measurement: Colorimetric determination.;Weight. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (after 12 weeks of intervention). Method of measurement: Digital scale.;Waist circumference. Timepoint: At the beginning

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAhmad Esmaillzadeh

Tehran University of Medical Sciences

a.esmaillzadeh@gmail.com+98 21 8895 5805

Outcome results

None listed

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