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Evaluation of the Combined Effects of Flaxseed Consumption and Fasting Mimicking Diet (FMD) on Patients with Non-Alcoholic Fatty Liver Diseases (NAFLD): a Randomized Control Trial

Evaluation of the Combined Effects of Flaxseed Consumption and Fasting Mimicking Diet (FMD) on Anthropometric Indices, Blood Lipid Composition, Glycemic Control, Inflammatory Markers, Steatosis and Hepatic Fibrosis in Patients with Non-Alcoholic Fatty Liver Diseases (NAFLD): a Randomized Control Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100524004010N36
Enrollment
100
Registered
2023-03-14
Start date
2023-03-12
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Non-alcoholic fatty liver. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: The first intervention group: (Fasting mimicking diet 16/8): the people were given nutritional recommendations to control the disease and a person is in a fasting mimicking mode for 16

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 years Having evidence of non-alcoholic steatohepatitis and CAP score over 263 Not having a history of alcohol and drug abuse Absence of other chronic and acute liver disorders No use of chemical and herbal medicines that affect the liver and weight Not having a chronic inflammatory disease and no history of cancer No treatment with anti-inflammatory drugs, corticosteroids and hormones Not having lost more than 8 percent of the weight in the last 6 months Blood pressure less than 140/90 mmHg Not having uncontrolled kidney disease, pituitary disorders, thyroid, cardiovascular diseases, diabetes and digestive system disorders that affect absorption No history of excessive consumption of flaxseed Not having clinically diagnosed psychiatric disorders that impair the patient's ability to provide written informed consent Willingness to participate in the study

Exclusion criteria

Exclusion criteria: Having clinically diagnosed psychiatric disorders that impair the patient's ability to provide written informed consent Use of other supplements Unwillingness to participate in the study

Design outcomes

Primary

MeasureTime frame
Level of steatosis and liver fibrosis. Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Fibroscan.

Secondary

MeasureTime frame
Lipid profile. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: blood sample.;Insulin sensitivity index. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: math formula.;Insulin resistance index. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: math formula.;Insulin concentration. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: blood sample.;Anthropometric indices. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: Tape measure, scale and mathematical formula.;Blood pressure. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: Sphygmomanometer.;High-sensitivity C-reactive protein. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: blood sample.;Liver enzymes alanine transaminase, aspartate aminotransferase,gamma-glutamyl tansferase. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: blood sample.;Serum glucose concentration. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: blood sample.;HbA1C. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: blood sample.

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