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

NCT07837323 | Completed DMC

• 1 other identifier: REC-UOL-607/24
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Enzymes; Glucose Levels; Lipid Profile

Keywords

Flaxseed oil; Olive oil,; MAFLD; Lipid profile; Liver enzymes

Outcome Measures

Primary Outcomes (4)

• 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.

  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 (%)

  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.

  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.

  16 weeks

Secondary Outcomes (1)

• lIPID PROFILE

  16 WEEKS

Study Arms (4)

T0. Control group

PLACEBO COMPARATOR

Conventional diet+treatment

Dietary Supplement: Conventional diet+treatment

T1: flaxseed oil

EXPERIMENTAL

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

Dietary Supplement: flaxseed oil

T2: extra virgin olive oil

EXPERIMENTAL

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

Dietary Supplement: extra virgin olive oil

T3: extra virgin olive oil + flaxseed oil

EXPERIMENTAL

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

Dietary Supplement: Flaxssed oil and extra virgin olive oil

Interventions

Conventional diet+treatment DIETARY_SUPPLEMENT

Conventional diet+treatment

T0. Control group

flaxseed oil DIETARY_SUPPLEMENT

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

T1: flaxseed oil

extra virgin olive oil DIETARY_SUPPLEMENT

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

T2: extra virgin olive oil

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)

T3: extra virgin olive oil + flaxseed oil

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

Sana Noreen

Lahore, Punjab Province, 54000, Pakistan

Location

Related Links

• Related Info

MeSH Terms

Interventions

Linseed Oil

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• sana noreen

  University of Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 23, 2026
• Study Start: June 25, 2024
• Primary Completion: June 26, 2024
• Study Completion: June 30, 2024
• Last Updated: September 23, 2026

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)