Effects of Phytosterol Supplementation on Liver Function and Inflammatory Status in Patients With Nonalcoholic Fatty Liver Disease
NCT06697977 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2026-05-08
Summary
Non-alcoholic fatty liver disease (NAFLD) is considered one of the most common chronic liver diseases worldwide, it recently became a worldwide problem with high morbidity which requires further attention. The use of natural bioactive products such as phytosterols have shown anti-NAFLD effect with little to no side effects when used as a supplement in the therapeutic protocol of NAFLD, in many animals, and In vitro studies.
Although the positive impacts of phytosterols on the prevention of hypercholesterolemia and improving liver functions have been reported in previous studies, further clinical experiments, especially human studies are needed to assure the effectiveness of phytosterols on improving liver enzymes, lipid profile, and insulin response in patients with NAFLD. In this study, we focus on the efficacy of phytosterol in a dose similar to the therapicutic lifestyle changes diet (TLC) recommendation with an aim to include it in the therapeutic protocol for NAFLD and to study the effect of some confounders that were excluded in previous studies on this relationship.
Conditions
- NAFLD
- Insulin Resistance
- Metabolic Syndrome
- Obesity
- Diabetes
- Nash
- Dyslipidemias
Interventions
- DIETARY_SUPPLEMENT
-
phytosterols
2 grams of phytosterols given as 7 pills per day
- DIETARY_SUPPLEMENT
-
placebo
placebo 7 pills per day
Sponsors & Collaborators
-
University of Jordan
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-15
- Primary Completion
- 2025-03-01
- Completion
- 2025-03-01
Countries
- Jordan
Study Locations
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