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Evaluation of the effects of Fasting Mimicking Diet (FMD) Combined with a Low-Sugar Diet on lipid profile, glycemic, inflammatory and histologic indices in Non-Alcoholic Fatty Liver (NAFLD): a randomized control trial

Evaluation of the effects of Fasting Mimicking Diet (FMD) Combined with a Low-Sugar Diet on lipid profile, glycemic, inflammatory and histologic indices in Non-Alcoholic Fatty Liver (NAFLD): a randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100524004010N31
Enrollment
75
Registered
2020-08-19
Start date
2020-09-22
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

Nonalcoholic fatty liver disease. Nonalcoholic steatohepatitis (NASH)

Interventions

Intervention 1: Control group: Dietary recommendations. Intervention 2: Intervention group: fasting diet (5 days of normal diet and two consecutive days with 75% calorie restriction and permission to

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: General desire to participate in the study Age 50-30 years - Has evidence of non-alcoholic steatohepatitis and CAP score more than 263 Body mass index (BMI) = 25kg / m2 No history of alcohol consumption Lack of other diseases and chronic and acute liver disorders (hepatitis B, C, etc.), biliary disease, known autoimmune diseases and hereditary disorders affecting the condition of the liver (iron, copper and ... ) No pregnancy or breastfeeding in women Do not take hepatotoxic drugs such as phenytoin, amoxifen and lithium Do not take antibiotics for more than a week during or before the study period Do not consume Milk thistle(Silybum marianum) Lack of chronic inflammatory disease No history of cancer Lack of treatment with anti-inflammatory drugs Lack of recent weight loss diet Blood pressure less than 90/160 mmHg No kidney disease (GFR greater than 60 or creatinine between 7-1.4) No weight loss of more than 8% in the last 6 months Do not use weight loss drugs (chemical drugs and effective herbal products)

Exclusion criteria

Exclusion criteria: Changes in medications (lipid-lowering drugs, blood sugar control drugs, and blood pressure medications) during the study period Lack of adherence to the diet given to patients Take supplements or substances that change the individual effect of the diet during the intervention.

Design outcomes

Primary

MeasureTime frame
Hepatic steatosis, Liver fibrosis. Timepoint: At the first and at the 12th week of the study. Method of measurement: fibroscan.

Secondary

MeasureTime frame
Weight. Timepoint: At the first and 12th week of the study. Method of measurement: Scale.;BMI. Timepoint: At the first and 12th week of the study. Method of measurement: Calculate.;Waist to hip ratio. Timepoint: At the first and 12th week of the study. Method of measurement: Calculate.;Liver enzymes (AST,ALT,GGT). Timepoint: At the first and 12th week of the study. Method of measurement: Enzymatic method.;Lipid profile (TG,Total cholesterol,LDL-C,HDL-C). Timepoint: At the first and 12th week of the study. Method of measurement: Enzymatic method.;FBS. Timepoint: At the first and 12th week of the study. Method of measurement: Enzymatic method.;Insulin. Timepoint: At the first and 12th week of the study. Method of measurement: Radioimmunoassay.;Hs-CRP. Timepoint: At the first and 12th week of the study. Method of measurement: ELISA.;CK-18. Timepoint: At the first and 12th week of the study. Method of measurement: ELISA.;HOMA-IR. Timepoint: At the first and 12th week of the study. Method of measurement: Calculate.;TAC. Timepoint: At the first and 12th week of the study. Method of measurement: ELISA.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzita Hekmatdoost

Shahid Beheshti University of Medical Sciences

a_hekmat2000@yahoo.com+98 21 2235 7483

Outcome results

None listed

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