Liver Enzymes, Glucose Levels, Lipid Profile
Conditions
Keywords
Flaxseed oil, Olive oil,, MAFLD, Lipid profile, Liver enzymes
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
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTConventional diet+treatment
Conventional diet+treatment
DIETARY_SUPPLEMENTflaxseed oil
Conventional diet+ treatment + flaxseed oil (22.5ml/day)
DIETARY_SUPPLEMENTextra virgin olive oil
Conventional diet+ treatment + extra virgin olive oil (22.5ml/day)
DIETARY_SUPPLEMENTFlaxssed oil and extra virgin olive oil
Conventional diet+ treatment + combined extra virgin olive oil (22.5 ml/day) plus flaxseed oil (22.5 ml/day)
Sponsors
University of Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | 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. |
| Glycated Hemoglobin Levels | 16 WEEKS | Glycated hemoglobin (HbA1c) reflects the average blood glucose level over the previous 2-3 months and is reported as a percentage (%) |
| Cytokeratin-18 (CK-18) Analysis | 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. |
| Liver Enzymes | 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
| Measure | Time frame | Description |
|---|---|---|
| lIPID PROFILE | 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 |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORsana noreen
University of Lahore
Outcome results
None listed