Liver EnzymesNCT07837323
Flaxseed Oil, Olive Oil, and Their Combination on Hepatic and Metabolic Outcomes in Patients With Metabolic Dysfunction-Associated Fatty Liver Disease
A study testing Conventional diet+treatment, flaxseed oil and extra virgin olive oil in people with Liver Enzymes and Glucose Levels, run by University of Lahore at 1 site in Pakistan.
Trial 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 Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Enzymes, Glucose Levels, Lipid Profile
- What is being tested?
- Conventional diet+treatment, flaxseed oil and extra virgin olive oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Jun 2024to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Liver Enzymes, Glucose Levels, Lipid Profile
- Being tested
- Conventional diet+treatment, flaxseed oil, extra virgin olive oil, Flaxssed oil and extra virgin olive oil
- Keywords
- Flaxseed oil, Olive oil,, MAFLD, Lipid profile, Liver enzymes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
Flaxssed oil and extra virgin olive oilDietary supplement
Conventional diet+ treatment + combined extra virgin olive oil (22.5 ml/day) plus flaxseed oil (22.5 ml/day)
| Study group | Role | What they receive |
|---|---|---|
| T0. Control group | Placebo comparator | Conventional diet+treatment Receives: Dietary Supplement: Conventional diet+treatment |
| T1: flaxseed oil | Experimental | Conventional diet+ treatment + flaxseed oil (22.5ml/day) Receives: Dietary Supplement: flaxseed oil |
| T2: extra virgin olive oil | Experimental | Conventional diet+ treatment + extra virgin olive oil (22.5ml/day) Receives: 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) Receives: Dietary Supplement: Flaxssed oil and extra virgin olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (%)
Measured: 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.
Measured: 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.
Measured: 16 weeks
Secondary outcomes (1)
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
Measured: 16 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start25 Jun 2024
- Primary completion26 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver EnzymesStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sana noreen, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837323
- Sponsor's protocol ID
- REC-UOL-607/24
- Status last verified
- Feb 2024
- First submitted
- 9 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flaxseed Oil, Olive Oil, and Their Combination on Hepatic and Metabolic Outcomes in Patients With Metabolic Dysfunction-Associated Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT07837323
- Acronym / sponsor ID
- REC-UOL-607/24
- Conditions
- Liver Enzymes, Glucose Levels, Lipid Profile
- Keywords
- Flaxseed oil, Olive oil,, MAFLD, Lipid profile, Liver enzymes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| T0. Control group | Placebo comparator | Dietary Supplement: Conventional diet+treatmentConventional diet+treatment |
| T1: flaxseed oil | Experimental | Dietary Supplement: flaxseed oilConventional diet+ treatment + flaxseed oil (22.5ml/day) |
| T2: extra virgin olive oil | Experimental | Dietary Supplement: extra virgin olive oilConventional diet+ treatment + extra virgin olive oil (22.5ml/day) |
| T3: extra virgin olive oil + flaxseed oil | Experimental | Dietary Supplement: Flaxssed oil and extra virgin olive oilConventional diet+ treatment + combined extra virgin olive oil (22.5 ml/day) plus flaxseed oil (22.5 ml/day) |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional diet+treatmentConventional diet+treatment | Dietary supplement | T0. Control group |
| flaxseed oilConventional diet+ treatment + flaxseed oil (22.5ml/day) | Dietary supplement | T1: flaxseed oil |
| extra virgin olive oilConventional diet+ treatment + extra virgin olive oil (22.5ml/day) | Dietary supplement | T2: extra virgin olive oil |
| Flaxssed oil and extra virgin olive oilConventional diet+ treatment + combined extra virgin olive oil (22.5 ml/day) plus flaxseed oil (22.5 ml/day) | Dietary supplement | T3: extra virgin olive oil + flaxseed oil |
Primary outcome
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.
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 (%)
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.
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.
1 secondary outcome
lIPID PROFILE
Time frame: 16 WEEKS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Liver Enzymes
Active, not recruitingPhase 2
MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
Mucopolysaccharidosis Disorders, Hurler Syndrome
Not yet recruiting
Prickly Pear Pulp Powder Along With an Anti-inflammatory Diet in Patients Having Liver Fibrosis
Lipid Profile, Blood Glucose
RecruitingPhase 3
A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
Alpha 1 Antitrypsin Deficiency
RecruitingPhase 2
Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders
Preeclampsia
Not yet recruitingPhase 2
An Extension Study of S-606001 in Participants With Late-onset Pompe Disease (LOPD)
Pompe Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sana noreen principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional diet+treatment, flaxseed oil and extra virgin olive oil in people with Liver Enzymes and Glucose Levels, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: 16 WEEKS). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.