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Completed

NCT Number: NCT07837323

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

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

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Key information

Conditions

Liver Enzymes Glucose Levels Lipid Profile

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sana Noreen

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional diet+treatment

Dietary Supplement

Conventional diet+treatment

Flaxseed oil

Dietary Supplement

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

Extra virgin olive oil

Dietary Supplement

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

Flaxssed oil and extra virgin olive oil

Dietary Supplement

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

Primary outcomes

  1. Body Mass Index

    Time frame: 16 WEEKS

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

  2. Glycated Hemoglobin Levels

    Time frame: 16 WEEKS

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

  3. Cytokeratin-18 (CK-18) Analysis

    Time frame: 16 WEEKS

    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.

  4. Liver Enzymes

    Time frame: 16 weeks

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

Secondary outcomes

  1. lIPID PROFILE

    Time frame: 16 WEEKS

    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

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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