]>
IRCT20250222064808N1 IRCT 2025-04-13 Tehran University of Medical Sciences 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 2025-06-22 anticipated 80 Recruiting https://irct.ir/trial/82338 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At the beginning of the study and before the intervention, random assignment of individuals to intervention groups will be done using the Stratified Block Randomization method. First, individuals will be grouped based on BMI (18.5 to 20.5, 20.5 to 22.5, and 22.5 to 25), and in each of these blocks, individuals who are matched in terms of BMI will be placed. Then, in each block, individuals will be randomly divided into two supplement and placebo groups. Randomization will be done using the Random Allocation Software (RAS). In this method, each group will be assigned one of the letters A and B, and randomization will be done in blocks of 4. Within each stratum, individuals will be randomly placed in one of the two study groups in a 1:1 ratio, Blinding description: The present study will be conducted in a double-blind manner, meaning that the participants, the principal investigator, and the evaluators will not identify individuals receiving the chromium picolinate supplement or the placebo. The appearance, color, taste, and odor of the chromium supplement and the placebo will be similar. As a result, the study participants will not know which supplement/placebo they were taking. Also, the supplements/placebos will be coded, and a person outside the study will know the codes and the type of supplement/placebo. The evaluators will deliver the supplements/placebos to the participants based on the code labeled on them and will not know the content of each supplement. 2-3 Metabolic dysfunction–associated steatotic liver disease. 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: Control group: Patients in this group will receive placebo for 12 weeks. The placebo is corn starch and will be consumed once a day. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Ahmad Esmaillzadeh
Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8895 5805 a.esmaillzadeh@gmail.com Tehran University of Medical Sciences scientific Ahmad Esmaillzadeh
Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8895 5805 a.esmaillzadeh@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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) 18 years 65 years Both 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) K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Placebo 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. Control group: Patients in this group will receive placebo for 12 weeks. The placebo is corn starch and will be consumed once a day. 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. 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 of the study (before the start of the intervention) and at the end of the study (after 12 weeks of intervention). Method of measurement: Measurement tape. Adverse events. 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: Questionnaire. Tehran University of Medical Sciences Approved 2025-02-26 Research ethics committee of school of medicine- Tehran University of Medical Sciences Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)