- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07622680
Comparative Effects of Mediterranean and DASH Diet on Hepatic Function
Comparative Effects of Mediterranean and DASH Diet on Hepatic Function in Patients Suffering From NAFLD
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Lahore, Pakistan
- University of Lahore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Lactating and pregnant women were not included.
- Patients who are using any kind of medicine.
- Adults suffering from critical health conditions, including cancer.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control group
Control group (T0): Participants were given dietary guidelines to manage fatty liver disease followed by medications.
|
Dietary guidelines for managing fatty liver disease followed by medication for 2 months.
|
|
Experimental: Treatment group (T1)
Treatment group (T1): Participants were given Mediterranean diet plan for 2 months.
|
Mediterranean diet plan consists of vegetables, whole grains, and fruit, extra virgin olive oil, nuts, seeds and legumes.
|
|
Experimental: Treatment group (T2)
Treatment group (T2): Participant were given DASH diet plan for 2 months.
|
DASH diet plan consists of antioxidant foods items i.e. fruits and vegetables lean meat and dairy products (low fat dairy products), nuts, grain.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
60 days
|
|
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.
|
60 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Liver Diseases
- Fatty Liver
- Non-alcoholic Fatty Liver Disease
- Therapeutics
- Diet, Food, and Nutrition
- Physiological Phenomena
- Nutritional Physiological Phenomena
- Health Care Economics and Organizations
- Diet, Plant-Based
- Diet Therapy
- Nutrition Therapy
- Diet
- Health Policy
- Public Policy
- Social Control Policies
- Policy
- Diet, Mediterranean
- Nutrition Policy
- Dietary Approaches To Stop Hypertension
Other Study ID Numbers
- IRB-UOL-FAHS/717/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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