NAFLDNCT06697977
Effects of Phytosterol Supplementation on Liver Function and Inflammatory Status in Patients With Nonalcoholic Fatty Liver Disease
A study testing phytosterols in people with NAFLD and Insulin Resistance, run by University of Jordan at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NAFLD, Insulin Resistance, Metabolic Syndrome
- What is being tested?
- phytosterols
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteJordan
- Study dates
- 15 Aug 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Phytosterol Supplementation on Serum Lipid Profile, Liver Enzymes, Insulin, Adiponectin, and Inflammatory Status in Patients With Nonalcoholic Fatty Liver Disease
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.
Read the 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.
- Conditions
- NAFLD, Insulin Resistance, Metabolic Syndrome, Obesity, Diabetes, Nash
- Being tested
- phytosterols, placebo
- Keywords
- phytosterols, NAFLD, Plant sterols, insulin, lipid profile
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Insulin Resistance, Metabolic Syndrome, Obesity, Diabetes Mellitus, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phytosterolsDietary supplement
2 grams of phytosterols given as 7 pills per day
placeboDietary supplement
placebo 7 pills per day
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Not described Receives: Dietary Supplement: phytosterols |
| control group | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
lab tests
liver enzymes (ALT, AST, GGT, ALK, Total protein, Direct bilirubin, Total bilirubin) mg/dl
Measured: from enrollment to the end of 3 months
lab tests
lipid profile (Cholesterol, HDL, LDL, TG) mg/dl
Measured: from enrollment to the end of 3 months
lab tests
insulin
Measured: from enrollment to the end of 3 months
lab tests
CRP
Measured: from enrollment to the end of 3 months
lab tests
adiponectin
Measured: from enrollment to the end of 3 months
Secondary outcomes (3)
Anthropometric measures
weight in kilograms
Measured: from enrollment to the end of 3 months
Anthropometric measures
waist circumference by centimetre
Measured: from enrollment to the end of 3 months
Vital signs
blood pressure
Measured: from enrollment to the end of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start15 Aug 2023
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shatha Hammad, Assistant Professor, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697977
- Sponsor's protocol ID
- 19/2022/458
- Status last verified
- May 2026
- First submitted
- 29 Oct 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Phytosterol Supplementation on Serum Lipid Profile, Liver Enzymes, Insulin, Adiponectin, and Inflammatory Status in Patients With Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT06697977
- Acronym / sponsor ID
- 19/2022/458
- Conditions
- NAFLD, Insulin Resistance, Metabolic Syndrome, Obesity, Diabetes, Nash
- Keywords
- phytosterols, NAFLD, Plant sterols, insulin, lipid profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Dietary Supplement: phytosterols |
| control group | Placebo comparator | Dietary Supplement: placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- history of liver transplantation.
- tested positive for any type of hepatitis.
- diagnosed with autoimmune hepatitis.
- significant alcohol consumption.
- current corticosteroids or antibiotics consumption.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phytosterols2 grams of phytosterols given as 7 pills per day | Dietary supplement | treatment group |
| placeboplacebo 7 pills per day | Dietary supplement | control group |
Primary outcome
lab tests
Time frame: from enrollment to the end of 3 months
liver enzymes (ALT, AST, GGT, ALK, Total protein, Direct bilirubin, Total bilirubin) mg/dl
lab tests
Time frame: from enrollment to the end of 3 months
lipid profile (Cholesterol, HDL, LDL, TG) mg/dl
lab tests
Time frame: from enrollment to the end of 3 months
insulin
lab tests
Time frame: from enrollment to the end of 3 months
CRP
lab tests
Time frame: from enrollment to the end of 3 months
adiponectin
3 secondary outcomes
Anthropometric measures
Time frame: from enrollment to the end of 3 months
Anthropometric measures
Time frame: from enrollment to the end of 3 months
Vital signs
Time frame: from enrollment to the end of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phytosterols in people with NAFLD and Insulin Resistance, run by University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lab tests (time frame: from enrollment to the end of 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.