Clinical trial NCT06697977: Effects of Phytosterol Supplementation on Liver Function and Inflammatory Status in Patients with Nonalcoholic Fatty Liver Disease
Official title: Effects of Phytosterol Supplementation on Serum Lipid Profile, Liver Enzymes, Insulin, Adiponectin, and Inflammatory Status in Patients with Nonalcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: NAFLD
Insulin Resistance
Metabolic Syndrome
Obesity
Diabetes
Nash
Dyslipidemias
Keywords: phytosterols
NAFLD
Plant sterols
insulin
lipid profile
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: A randomized, double-blind, placebo-controlled, parallel experimental trial will be conducted to explore the therapeutic potential of phytosterol supplementation against NAFLD. Patients with NAFLD will be recruited from Jordan University Hospital, Department of Gastroenterology and Hepatology.

Forty adult patients, males and females, aged less than 70, who are diagnosed with NAFLD by liver ultrasonography, and who are willing to participate will be invited to join the clinical trial and will be informed that they can leave the study whenever they want.

Participants with any history of liver transplantation, tested positive for any type of hepatitis, autoimmune hepatitis, alcohol consumption, current corticosteroids or antibiotics consumption, rapid weight loss, heart failure, renal disease, pregnant and lactating women, patients with BMI higher than 40, or who have unintentional weight loss of 5%, and patients who are consuming other supplements within three months of the study will be excluded.

A specialized physician will examine the patients, confirm the diagnosis, and ensure that all volunteers fit the inclusion criteria.

The 40 patients will be randomly divided into two groups, using a random number generator at randomization.com; the phytosterols group (n=20), who will receive capsulated 2.0g oral phytosterol powder which will be consumed with meals daily, and the control group (n= 20) who will receive a placebo capsule (microcrystalline cellulose) of 2.0g daily. Each intervention will extend for two months, and the actual intervention phases will be preceded by a 2-week run-in period, in which the participants will be asked to refrain from the consumption of high stanols and sterols in their diets.

For the entire duration of the study, patients will follow their habitual diets but will be advised to avoid high-fat foods, their physical activity will also be monitored and data on both dietary habits and physical activity will be assessed at baseline (week 0) and after the end of the study (week 8). All participants will be asked to come to the clinics every 2 weeks to collect their supplements and fill in the required questionnaires and supplement consumption checklist.

Eligibility criteria: Inclusion Criteria:

* any patient with NAFLD or NASH that has been diagnosed by any type of imaging.
* ability to swallow pills.
* ability to take the supplement for 3 months.

Exclusion Criteria:

* history of liver transplantation.
* tested positive for any type of hepatitis.
* diagnosed with autoimmune hepatitis.
* significant alcohol consumption.
* current corticosteroids or antibiotics consumption.
* rapid unintentional weight loss.
* diagnosed with heart failure.
* diagnosed with renal disease.
* pregnant and lactating women.
* patients with a BMI higher than 40.
* patients who are consuming other supplements within the last three months.

Primary outcomes:
measure: lab tests
timeFrame: from enrollment to the end of 3 months
measure: lab tests
timeFrame: from enrollment to the end of 3 months
measure: lab tests
timeFrame: from enrollment to the end of 3 months
measure: lab tests
timeFrame: from enrollment to the end of 3 months
measure: lab tests
timeFrame: from enrollment to the end of 3 months
Secondary outcomes:
measure: Anthropometric measures
timeFrame: from enrollment to the end of 3 months
measure: Anthropometric measures
timeFrame: from enrollment to the end of 3 months
measure: Vital signs
timeFrame: from enrollment to the end of 3 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: University of Jordan
Study officials:
References: