Effects of Phytosterol Supplementation on Liver Function and Inflammatory Status in Patients with Nonalcoholic Fatty Liver Disease

NCT06697977 | Active Not Recruiting

• 1 other identifier: 19/2022/458
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

NAFLD; Insulin Resistance; Metabolic Syndrome; Obesity; Diabetes; Nash; Dyslipidemias

Keywords

phytosterols; NAFLD; Plant sterols; insulin; lipid profile

Outcome Measures

Primary Outcomes (5)

• lab tests

  liver enzymes (ALT, AST, GGT, ALK, Total protein, Direct bilirubin, Total bilirubin) mg/dl

  from enrollment to the end of 3 months

• lab tests

  lipid profile (Cholesterol, HDL, LDL, TG) mg/dl

  from enrollment to the end of 3 months

• lab tests

  insulin

  from enrollment to the end of 3 months

• lab tests

  CRP

  from enrollment to the end of 3 months

• lab tests

  adiponectin

  from enrollment to the end of 3 months

Secondary Outcomes (3)

• Anthropometric measures

  from enrollment to the end of 3 months

• Anthropometric measures

  from enrollment to the end of 3 months

• Vital signs

  from enrollment to the end of 3 months

Study Arms (2)

treatment group

EXPERIMENTAL

Dietary Supplement: phytosterols

control group

PLACEBO COMPARATOR

Dietary Supplement: placebo

Interventions

phytosterols DIETARY_SUPPLEMENT

2 grams of phytosterols given as 7 pills per day

treatment group

placebo DIETARY_SUPPLEMENT

placebo 7 pills per day

control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

University of Jordan

Amman, Jordan

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Insulin Resistance; Metabolic Syndrome; Obesity; Diabetes Mellitus; Dyslipidemias

Interventions

Phytosterols

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endocrine System Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Sterols; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Membrane Lipids; Lipids; Phytochemicals; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 20, 2024
• Study Start: August 15, 2023
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

JO (1)