NAFLD (Nonalcoholic Fatty Liver Disease)NCT07622680
Comparative Effects of Mediterranean and DASH Diet on Hepatic Function
A study testing Dietary guidelines for fatty liver, Mediterranean diet and DASH diet in people with NAFLD (Nonalcoholic Fatty Liver Disease) and Hep A, run by University of Lahore at 1 site in Pakistan.
Trial summary
Participants were assigned into three groups Control group recieving general dietary guidelines, Mediterranean diet intervention group DASH dietary intervention group Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- NAFLD (Nonalcoholic Fatty Liver Disease), Hep A
- What is being tested?
- Dietary guidelines for fatty liver, Mediterranean diet and DASH diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Nov 2025to 20 Feb 2026
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (25-70 years) of both genders with BMI (above 25 kg/m2).
- Fatty liver patients with mild to moderate values of Alanine Transaminase (ALT) level range from mild to moderate (30-100U/L)
- Fatty liver patients having Aspartate Aminotransferase (AST) level range from mild to moderate (200-600 IU/L).
- Fatty liver patients having Gamma-Glutamyl Transferase (GGT level range from mild to moderate(120-300 U/L) were included.
Who cannot join
- Lactating and pregnant women were not included.
- Patients who are using any kind of medicine.
- Adults suffering from critical health conditions, including cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Mediterranean and DASH Diet on Hepatic Function in Patients Suffering From NAFLD
Participants were assigned into three groups Control group recieving general dietary guidelines, Mediterranean diet intervention group DASH dietary intervention group
Read the detailed description
Written permission was taken from the ethical board for data collection. After taking informed consent from patients in written form, the researcher used self-administered questionnaire or Performa to gather data. NAFLD patients (both genders) of age 25 to 70 years were included.
- Screening: The participants eligible under inclusion criteria will be enrolled. The baseline data (weight, height, BMI, waist circumference, LFT's, Lipid profile, blood pressure). The target population between 25-70 years were selected.
- Allocation: The participants were assigned into three groups; control group was given dietary guidelines followed by medication; one group was given Mediterranean diet (T1) and other group was given DASH diet (T2) along with conventional therapy
- Follow up:
The follow up of patient were conducted monthly, all laboratory test (LFT's, Lipid profile, blood pressure) were conducted on 1st and after 8th week. The baseline and post-test study were compared to test hypothesis.
- Conditions
- NAFLD (Nonalcoholic Fatty Liver Disease), Hep A
- Being tested
- Dietary guidelines for fatty liver, Mediterranean diet, DASH diet
- Keywords
- Mediterranean Diet,, DASH diet,, Liver Function Test,, Lipid profile,
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary guidelines for fatty liverOther
Dietary guidelines for managing fatty liver disease followed by medication for 2 months.
Mediterranean dietOther
Mediterranean diet plan consists of vegetables, whole grains, and fruit, extra virgin olive oil, nuts, seeds and legumes.
DASH dietOther
DASH diet plan consists of antioxidant foods items i.e. fruits and vegetables lean meat and dairy products (low fat dairy products), nuts, grain.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Control group (T0): Participants were given dietary guidelines to manage fatty liver disease followed by medications. Receives: Other: Dietary guidelines for fatty liver |
| Treatment group (T1) | Experimental | Treatment group (T1): Participants were given Mediterranean diet plan for 2 months. Receives: Other: Mediterranean diet |
| Treatment group (T2) | Experimental | Treatment group (T2): Participant were given DASH diet plan for 2 months. Receives: Other: DASH diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Body Mass Index (BMI) was computed by dividing weight in kilograms by the square of height in meters (kg/m2).
Measured: 60 days
Liver Function Test
The blood test was used to measure the serum concentrations of ALT, AST, and GGT. Following an overnight fast, 10 ml of venous blood was collected from participants both at baseline and post-intervention.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start12 Nov 2025
- Primary completion17 Jan 2026
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLD (Nonalcoholic Fatty Liver Disease)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Aslam, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622680
- Sponsor's protocol ID
- IRB-UOL-FAHS/717/2025
- Status last verified
- May 2026
- First submitted
- 23 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared in the form of research articles without the personal information of the participant
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Mediterranean and DASH Diet on Hepatic Function in Patients Suffering From NAFLD
- ClinicalTrials.gov ID
- NCT07622680
- Acronym / sponsor ID
- IRB-UOL-FAHS/717/2025
- Conditions
- NAFLD (Nonalcoholic Fatty Liver Disease), Hep A
- Keywords
- Mediterranean Diet,, DASH diet,, Liver Function Test,, Lipid profile,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 17 Jan 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 3 Jun 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.
Participants were assigned into three groups Control group recieving general dietary guidelines, Mediterranean diet intervention group DASH dietary intervention group
Detailed description
Written permission was taken from the ethical board for data collection. After taking informed consent from patients in written form, the researcher used self-administered questionnaire or Performa to gather data. NAFLD patients (both genders) of age 25 to 70 years were included.
- Screening: The participants eligible under inclusion criteria will be enrolled. The baseline data (weight, height, BMI, waist circumference, LFT's, Lipid profile, blood pressure). The target population between 25-70 years were selected.
- Allocation: The participants were assigned into three groups; control group was given dietary guidelines followed by medication; one group was given Mediterranean diet (T1) and other group was given DASH diet (T2) along with conventional therapy
- Follow up:
The follow up of patient were conducted monthly, all laboratory test (LFT's, Lipid profile, blood pressure) were conducted on 1st and after 8th week. The baseline and post-test study were compared to test hypothesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Dietary guidelines for fatty liverControl group (T0): Participants were given dietary guidelines to manage fatty liver disease followed by medications. |
| Treatment group (T1) | Experimental | Other: Mediterranean dietTreatment group (T1): Participants were given Mediterranean diet plan for 2 months. |
| Treatment group (T2) | Experimental | Other: DASH dietTreatment group (T2): Participant were given DASH diet plan for 2 months. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (25-70 years) of both genders with BMI (above 25 kg/m2).
- Fatty liver patients with mild to moderate values of Alanine Transaminase (ALT) level range from mild to moderate (30-100U/L)
- Fatty liver patients having Aspartate Aminotransferase (AST) level range from mild to moderate (200-600 IU/L).
- Fatty liver patients having Gamma-Glutamyl Transferase (GGT level range from mild to moderate(120-300 U/L) were included.
Key exclusion criteria (3 listed)
- Lactating and pregnant women were not included.
- Patients who are using any kind of medicine.
- Adults suffering from critical health conditions, including cancer.
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 |
|---|---|---|
| Dietary guidelines for fatty liverDietary guidelines for managing fatty liver disease followed by medication for 2 months. | Other | Control group |
| Mediterranean dietMediterranean diet plan consists of vegetables, whole grains, and fruit, extra virgin olive oil, nuts, seeds and legumes. | Other | Treatment group (T1) |
| DASH dietDASH diet plan consists of antioxidant foods items i.e. fruits and vegetables lean meat and dairy products (low fat dairy products), nuts, grain. | Other | Treatment group (T2) |
Primary outcome
Body Mass Index
Time frame: 60 days
Body Mass Index (BMI) was computed by dividing weight in kilograms by the square of height in meters (kg/m2).
Liver Function Test
Time frame: 60 days
The blood test was used to measure the serum concentrations of ALT, AST, and GGT. Following an overnight fast, 10 ml of venous blood was collected from participants both at baseline and post-intervention.
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 3 Jun 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will be shared in the form of research articles without the personal information of the participant
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary guidelines for fatty liver, Mediterranean diet and DASH diet in people with NAFLD (Nonalcoholic Fatty Liver Disease) and Hep A, 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 3 Jun 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: 60 days). The study lists 2 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 3 Jun 2026.