Flaxseed Oil, Olive Oil, and Their Combination on Hepatic and Metabolic Outcomes in Patients With Metabolic Dysfunction-Associated Fatty Liver Disease

University of Lahore112 enrolled

Overview

This 16-week randomized controlled trial evaluated the effects of flaxseed oil, extra virgin olive oil, and their combination on biochemical hepatic and metabolic outcomes in patients with MAFLD. The study assessed CK-18 as the primary outcome, with BMI, HbA1c, liver enzymes, and lipid profile as secondary outcom

This 16-week, four-arm randomized controlled trial involving 112 patients with MAFLD evaluated the effects of flaxseed oil, extra virgin olive oil, and their combined supplementation compared with a control group. The study primarily assessed serum CK-18, with BMI, HbA1c, liver enzymes, and lipid profile as secondary biochemical and metabolic outcomes to evaluate the potential benefits of these dietary oils.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

112

Conditions

Liver Enzymes Glucose Levels Lipid Profile

Interventions

Conventional diet+treatmentDIETARY_SUPPLEMENT

Conventional diet+treatment

flaxseed oilDIETARY_SUPPLEMENT

Conventional diet+ treatment + flaxseed oil (22.5ml/day)

extra virgin olive oilDIETARY_SUPPLEMENT

Conventional diet+ treatment + extra virgin olive oil (22.5ml/day)

Eligibility

Sex: ALLMin age: 45 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Participants aged 45-65 years, with a confirmed diagnosis of metabolic dysfunction-associated fatty liver disease (MAFLD), * a body mass index (BMI) ≥25 kg/m², * HbA1c ≥5.7%, * elevated serum cytokeratin-18 (CK-18) Exclusion Criteria: * Participants who had initiated or changed hypoglycemic, lipid-lowering, antihypertensive, hepatoprotective, corticosteroid, or weight-loss medications within the three months preceding enrollment were excluded, * Pregnant or lactating women, individuals with known allergies or hypersensitivity to flaxseed, olive oil, or other herbal products used in the intervention, * participants with severe hepatic, renal, cardiovascular, or other systemic diseases that could interfere with the study outcomes

Locations (1)

Sana Noreen

Lahore, Punjab Province, Pakistan

Outcomes

Primary Outcomes

Body Mass Index

BMI (Body Mass Index) is a measure of body weight relative to height, calculated as weight (kg) ÷ height² (m²) and expressed in kg/m².

Time frame: 16 WEEKS

Glycated Hemoglobin Levels

Glycated hemoglobin (HbA1c) reflects the average blood glucose level over the previous 2-3 months and is reported as a percentage (%)

Time frame: 16 WEEKS

Cytokeratin-18 (CK-18) Analysis

Cytokeratin-18 (CK-18) is a biomarker of hepatocyte apoptosis and liver injury, commonly measured in serum and reported according to the specific assay used.

Time frame: 16 WEEKS

Liver Enzymes

Liver enzymes are blood biomarkers used to assess liver injury and function, commonly including ALT, AST, ALP, and GGT, reported in U/L.

Time frame: 16 weeks

Secondary Outcomes

lIPID PROFILE

Lipid profile measures blood lipids, including total cholesterol (TC), triglycerides (TG), LDL-C, and HDL-C, which are important indicators of cardiovascular and metabolic health.mg/dL

Time frame: 16 WEEKS

Data from ClinicalTrials.gov

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