Dietary Intervention Study on Liver Health in Young Adults

ConditionLiver Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-30
SponsorHochschule Campus Wien (University of Applied Sciences Campus Vienna)

About this trial

This prospective randomized dietary intervention study investigates the effects of two dietary approaches on liver health in young adults over a 12-week period. Participants will be randomly assigned to either a Mediterranean diet intervention or a healthy diet based on general dietary recommendations.

Liver health will be assessed using the Ultrasound-Guided Attenuation Parameter (UGAP), together with laboratory parameters, body composition measurements, and anthropometric assessments. Measurements will be performed at baseline, after 6 weeks, and after 12 weeks.

The study aims to evaluate changes in liver fat and related metabolic parameters over time and to investigate associations between UGAP measurements, laboratory parameters, and body composition.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 20 to 30 years

Currently enrolled as a student

Body mass index (BMI) less than or equal to 29 kg/m²

Willingness to attend all three study visits at baseline, Week 6, and Week 12

Disqualifiers

Known acute or chronic liver disease, including non-alcoholic fatty liver disease (NAFLD) or metabolic dysfunction-associated steatotic liver disease (MASLD)

Acute hepatitis

History of liver transplantation

Excessive alcohol consumption

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mediterranean Diet Intervention

    Behavioral

    Participants receive standardized dietary education and are instructed to follow a Mediterranean dietary pattern for 12 weeks. Core recommendations include approximately 4 tablespoons of olive oil per day, fish 2-3 times per week, legumes at least 3 times per week, and nuts or seeds at least 3 times per week. Participants are additionally encouraged to consume vegetables, fruits, whole-grain foods, and other foods characteristic of a Mediterranean dietary pattern, while limiting foods that are not characteristic of this dietary pattern.

  • General Healthy Diet Intervention

    Behavioral

    Participants receive standardized dietary education based on general healthy eating recommendations for 12 weeks. Participants are encouraged to maintain their usual dietary habits while incorporating general healthy dietary recommendations, including the preferential use of plant-based oils instead of animal fats. The intervention does not specifically promote a Mediterranean dietary pattern.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Mediterranean Diet InterventionExperimental treatment 1 intervention
Group B: Control Group - General Dietary RecommendationsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in Ultrasound-Guided Attenuation Parameter (UGAP)

Liver steatosis will be quantitatively assessed using the Ultrasound-Guided Attenuation Parameter (UGAP). Change from baseline will be assessed at Week 6 and Week 12.

Time frame
Baseline, Week 6, and Week 12

Secondary outcomes

1

Change in Visual Liver Steatosis Grade

Liver steatosis will be visually assessed and classified into steatosis grades 0-3. Changes in steatosis grade will be assessed over the 12-week intervention period.

Time frame
Baseline, Week 6, and Week 12
2

Change From Baseline in Urinary Albumin Concentration

Urinary albumin concentration will be assessed in spontaneous urine samples. Change from baseline will be assessed at Week 6 and Week 12.

Time frame
Baseline, Week 6, and Week 12
3

Change From Baseline in Aspartate Aminotransferase (AST)

Aspartate aminotransferase (AST) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12.

Time frame
Baseline, Week 6, and Week 12
4

Change From Baseline in Alanine Aminotransferase (ALT)

Alanine aminotransferase (ALT) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12.

Time frame
Baseline, Week 6, and Week 12

Other outcomes

1

Change From Baseline in DNA Damage Measured as Percentage of DNA in the Comet Tail

DNA damage will be assessed using the comet assay and expressed as the percentage of DNA in the comet tail (% tail DNA). Change from baseline will be assessed at Week 6 and Week 12.

Time frame
Baseline, Week 6, and Week 12
2

Change From Baseline in Malondialdehyde (MDA) Concentration

Malondialdehyde (MDA) concentration will be assessed as a biomarker of oxidative stress. Change from baseline will be assessed at Week 6 and Week 12.

Time frame
Baseline, Week 6, and Week 12
3

Change From Baseline in Ferric Reducing Antioxidant Power (FRAP)

Ferric reducing antioxidant power (FRAP) will be assessed as a measure of antioxidant capacity. Change from baseline will be assessed at Week 6 and Week 12.

Time frame
Baseline, Week 6, and Week 12
4

Change From Baseline in Plasma Reduced Glutathione (GSH) Concentration

Plasma reduced glutathione (GSH) concentration will be assessed as a marker of redox status. Change from baseline will be assessed at Week 6 and Week 12.

Time frame
Baseline, Week 6, and Week 12

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