- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Lahore, Pakistan
- University of Lahore
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Placebo komparator: Control group
Control group (T0): Participants were given dietary guidelines to manage fatty liver disease followed by medications.
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Dietary guidelines for managing fatty liver disease followed by medication for 2 months.
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Eksperimentel: Treatment group (T1)
Treatment group (T1): Participants were given Mediterranean diet plan for 2 months.
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Mediterranean diet plan consists of vegetables, whole grains, and fruit, extra virgin olive oil, nuts, seeds and legumes.
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Eksperimentel: Treatment group (T2)
Treatment group (T2): Participant were given DASH diet plan for 2 months.
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DASH diet plan consists of antioxidant foods items i.e. fruits and vegetables lean meat and dairy products (low fat dairy products), nuts, grain.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Body Mass Index
Tidsramme: 60 days
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Body Mass Index (BMI) was computed by dividing weight in kilograms by the square of height in meters (kg/m2).
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60 days
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Liver Function Test
Tidsramme: 60 days
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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.
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60 days
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Leversygdomme
- Fed lever
- Ikke-alkoholisk fedtleversygdom
- Terapeutik
- Diæt, mad og ernæring
- Fysiologiske fænomener
- Ernæringsfysiologiske fænomener
- Sundhedsøkonomi og organisationer
- Diæt, plantebaseret
- Diætterapi
- Ernæringsterapi
- Kost
- Sundhedspolitik
- Offentlig politik
- Sociale kontrolpolitikker
- Politik
- Diæt, Middelhavet
- Ernæringspolitik
- Diætmetoder til at stoppe hypertension
Andre undersøgelses-id-numre
- IRB-UOL-FAHS/717/2025
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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