The effect of hypocaloric diet and omega-3 fatty acid supplementation on overweight and obesity

The effect of a hypocaloric diet and omega-3 fatty acid supplementation on serum levels of liver enzymes, lipid profile and insulin resistance in overweight and obese patients with non-alcoholic fatty liver disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016082429508N1

Enrollment

114

Registered

2016-09-20

Start date

2016-09-22

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

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

Interventions

Intervention 1: First intervention group: Thirty eight patients with Nafld will receive a hypocaloric diet program consisting of 50% carbohydrates, 20% protein and 30% fat with a goal of 5% weight red

Treatment - Other

First intervention group: Thirty eight patients with Nafld will receive a hypocaloric diet program consisting of 50% carbohydrates, 20% protein and 30% fat with a goal of 5% weight reduction. Dietary

Second intervention group: Thirty eight patients with Nafld will take 2 omega-3 fatty acids capsules per day providing 1500 mg EPA+DHA. Dietary intake will assess by 24-hour recall method for 3 days a

Control group: no intervention

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age between 18 and 65 years; the diagnosis of Nafld is established by the presence of steatosis of the liver on ultrasound associated with a persistent increase in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) of 1.5-4 times the upper limit of normal and AST:ALT<1; body mass index between 25 and 40 kg/m2; having informed consent. Exclusion criteria: pregnancy and lactation; alcohol consumption; substance abuse; engaging in strenuous exercise; any known pathological condition affecting the liver, e.g., autoimmune liver disease, hepatic virus infection, hepatobiliary disease,history of liver transplantation, hereditary defects (Wilson disease, hemochromatosis, ...), neoplasm, cardiovascular disease, endocrine disorders (diabetes mellitus, untreated hypothyroidism,...), bariatric surgery within the past year, engagement in an active weight loss program or taking weight-loss medication within the 3 months before the study, omega-3 fatty acid supplementation within the 3 months before the study; treatment with some medications (anticoagulant drugs, insulin-sensitizing drugs, statins, vitamin E), steatogenic and hepatotoxic medications and use of any medicine or dietary supplement that could influence glucose and lipid metabolism within the 3 months before the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Fasting blood sugar. Timepoint: At baseline and after 3 month. Method of measurement: measured in milligram per deciliter, using colorimetry method.;Fasting insulin. Timepoint: At baseline and after 3 month. Method of measurement: measured in microUnit/milliliter, using Elisa.;HOMA-IR. Timepoint: At baseline and after 3 month. Method of measurement: using formula.;High density lipoprotein (HDL-C). Timepoint: At baseline and after 3 month. Method of measurement: measured in milligram per deciliter, using colorimetry method.;Low density lipoprotein (LDL-C). Timepoint: At baseline and after 3 month. Method of measurement: measured in milligram per deciliter, using colorimetry method.;Total cholesterol. Timepoint: At baseline and after 3 month. Method of measurement: measured in milligram per deciliter, using colorimetry method.;Triglyceride. Timepoint: At baseline and after 3 month. Method of measurement: measured in milligram per deciliter, using colorimetry method.;Alanine aminotransferase (ALT). Timepoint: At baseline and after 3 month. Method of measurement: measured in international units/liter, using colorimetry method.;Aspartate aminotransferase (AST). Timepoint: At baseline and after 3 month. Method of measurement: measured in international units/liter, using colorimetry method.;Weight. Timepoint: At baseline and after 3 month. Method of measurement: measured in kilograms, using digital scale.;Waist circumference. Timepoint: At baseline and after 3 month. Method of measurement: measured in centimeter, using a soft tape.;Body mass index. Timepoint: At baseline and after 3 month. Method of measurement: kg/m2, using standard formula.;Height. Timepoint: At baseline and after 3 month. Method of measurement: measured in meter, using mounted tape.	—

Measure

Time frame

Fasting blood sugar. Timepoint: At baseline and after 3 month. Method of measurement: measured in milligram per deciliter, using colorimetry method.;Fasting insulin. Timepoint: At baseline and after 3 month. Method of measurement: measured in microUnit/milliliter, using Elisa.;HOMA-IR. Timepoint: At baseline and after 3 month. Method of measurement: using formula.;High density lipoprotein (HDL-C). Timepoint: At baseline and after 3 month. Method of measurement: measured in milligram per deciliter, using colorimetry method.;Low density lipoprotein (LDL-C). Timepoint: At baseline and after 3 month. Method of measurement: measured in milligram per deciliter, using colorimetry method.;Total cholesterol. Timepoint: At baseline and after 3 month. Method of measurement: measured in milligram per deciliter, using colorimetry method.;Triglyceride. Timepoint: At baseline and after 3 month. Method of measurement: measured in milligram per deciliter, using colorimetry method.;Alanine aminotransferase (ALT). Timepoint: At baseline and after 3 month. Method of measurement: measured in international units/liter, using colorimetry method.;Aspartate aminotransferase (AST). Timepoint: At baseline and after 3 month. Method of measurement: measured in international units/liter, using colorimetry method.;Weight. Timepoint: At baseline and after 3 month. Method of measurement: measured in kilograms, using digital scale.;Waist circumference. Timepoint: At baseline and after 3 month. Method of measurement: measured in centimeter, using a soft tape.;Body mass index. Timepoint: At baseline and after 3 month. Method of measurement: kg/m2, using standard formula.;Height. Timepoint: At baseline and after 3 month. Method of measurement: measured in meter, using mounted tape.

—

Secondary

Measure	Time frame
Physical activity level. Timepoint: At baseline and after 3 month. Method of measurement: international physical activity questionnaire short form (IPAQ-SF).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Rasoul Zarrin

Urmia University of Medical Sciences

Rasoul.zarrin@uqconnect.edu.au; wwzarrin@yahoo.com+98 44 3346 9935

Outcome results

None listed

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