Metabolic dysfunction-associated steatotic liver disease. Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention 1: First Intervention group: 6 grams of soluble fiber powder containing a 1:1 mixture of inulin and glucomannan with a purity level of over 95%, sourced from Sepidaj Iran, administered as
Sponsors
Shiraz University of Medical Sciences
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Diagnosis of MASLD: Steatosis of at least grade 1 diagnosed via ultrasound, plus at least one of the following 5 criteria: Overweight or obesity: 1. Body Mass Index (BMI) = 25 kg/m² OR waist circumference > 94 cm in men and > 80 cm in women. 2. Prediabetes or diabetes: Fasting blood glucose = 100 mg/dl, or 2-hour post-load glucose = 140 mg/dl, or HbA1c = 5.7%, or a clinical diagnosis of type 2 diabetes, or current use of glucose-lowering medication. 3. Hypertension: Systolic blood pressure = 130 mmHg, or diastolic = 85 mmHg, or current use of antihypertensive medication. 4. Elevated triglycerides: Triglycerides = 150 mg/dl or current use of lipid-lowering medication. 5. Low HDL-C: HDL-C = 40 mg/dl in men and = 50 mg/dl in women, or current use of lipid-lowering medication. Condition: Alcohol consumption must be less than 140 grams per week for women and less than 210 grams per week for men. Age 18 to 65 years old Body Mass Index (BMI) = 25 kg/m² Not currently pregnant or breastfeeding
Exclusion criteria
Exclusion criteria: Diagnosis of liver cirrhosis or other liver diseases such as hepatitis, cholangitis, or drug-induced liver injury. Presence of gastrointestinal disorders requiring caution with fiber intake, such as narrowing or obstruction of the digestive tract, Inflammatory Bowel Disease (IBD), or Irritable Bowel Syndrome (IBS). Any intestinal infections within the last month. Consumption of dietary supplements containing fiber, probiotics, or prebiotics within the last month. Use of nutritional supplements such as Omega-3, multivitamins, and minerals. Use of antibiotics within the last month. Adherence to specific dietary regimens, including fasting, ketogenic diet, vegetarianism, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatty liver grade. Timepoint: week 0, after week 12. Method of measurement: ultrasound.;Alanine Aminotransferase. Timepoint: week 0, after week 12. Method of measurement: Measurement in serum with commercial kit.;Aspartate Aminotransferase. Timepoint: week 0, after week 12. Method of measurement: Measurement in serum with a commercial kit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight. Timepoint: week 0, end of week 6, after week 12. Method of measurement: Scale.;Waist circumference. Timepoint: week 0, end of week 6, after week 12. Method of measurement: measurement tape.;Body fat percentage. Timepoint: week 0, end of week 6, after week 12. Method of measurement: Bioelectrical impedance analysis.;Fasting blood sugar. Timepoint: week 0, after week 12. Method of measurement: Commercial kit.;Insulin. Timepoint: week 0, after week 12. Method of measurement: Commercial ELISA kit.;Total cholesterol. Timepoint: week 0, after week 12. Method of measurement: Commercial kit.;Low density lipoprotein. Timepoint: week 0, after week 12. Method of measurement: Commercial kit.;High density lipoprotein. Timepoint: week 0, after week 12. Method of measurement: Commercial kit.;Triglyceride. Timepoint: week 0, after week 12. Method of measurement: Commercial kit.;Appetite. Timepoint: week 0, end of week 6, after week 12. Method of measurement: visual analogue scale.;Lipopolysaccharide binding protein. Timepoint: week 0, after week 12. Method of measurement: Commercial ELISA kit. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Kohanmoo
Shiraz University of Medical Sciences
Outcome results
None listed