Metabolic Dysfunction-Associated Steatotic Liver DiseaseNCT07524621
The Impact of Nutrition Education and Rice Bran Supplementation on Metabolic Dysfunction-associated Steatotic Liver Disease
A study testing Nutrition Education and Rice Bran in people with Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Shih Chien University at 1 site in Taiwan.
Trial summary
This study aims to evaluate the effects of nutrition education with or without rice bran supplementation in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease
- What is being tested?
- Nutrition Education and Rice Bran
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Aug 2021to 5 Aug 2023
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- overweight or obese (BMI > 24 kg/m²)
- diagnosed by a physician with moderate fatty liver (grade II)
Who cannot join
- had stage 3 or higher chronic kidney disease
- were undergoing treatment for malignant disease
- had hepatitis B or hepatitis C infection or carrier status
- had alcoholic hepatitis
- had a known allergy to rice bran.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the effects of nutrition education with or without rice bran supplementation in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Participants were recruited from the Division of Gastroenterology and Hepatology at Changhua Christian Hospital and assigned to either a nutrition education (NE) group or a nutrition education plus rice bran (NERB) group. The intervention was conducted for a specified study period, during which participants received dietary guidance and follow-up assessments.
The primary objective of this study is to determine whether rice bran supplementation in addition to nutrition education provides greater benefits on body weight, body mass index, dietary intake, and metabolic parameters compared with nutrition education alone. Secondary outcomes include changes in liver-related biochemical markers, glycemic indicators, lipid profiles, and other anthropometric measurements.
This study may provide evidence on the potential role of rice bran as a functional dietary supplement for improving metabolic health in patients with MASLD and may support the development of practical nutritional strategies for disease management.
- Being tested
- Nutrition Education, Rice Bran
- Keywords
- MASLD, Rice Bran, Nutrition Education, Liver Steatosis, Functional Food, Body Weight
- Medical subject headings
- Fatty Liver, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition EducationBehavioural
Participants received structured nutrition education during the study period.
Rice BranDietary supplement
Participants received structured nutrition education together with rice bran supplementation during the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| NE Group | Active comparator | Participants in this arm received structured nutrition education during the study period. Receives: Behavioral: Nutrition Education |
| NERB Group | Experimental | Participants received structured nutrition education together with rice bran supplementation during the intervention period. Receives: Behavioral: Nutrition Education; Dietary Supplement: Rice Bran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Body weight was measured to evaluate the effect of nutrition education with or without rice bran supplementation.
Measured: From enrollment to the end of treatment at 3 months
Secondary outcomes (16)
Change in body mass index
Body mass index was measured to evaluate the effect of nutrition education with or without rice bran supplementation.
Measured: From enrollment to the end of treatment at 3 months
Change in waist circumference
Waist circumference was measured to assess changes in central adiposity following the intervention.
Measured: From enrollment to the end of treatment at 3 months
Change in body fat percentage
Body fat percentage was measured to assess changes in body composition following the intervention.
Measured: From enrollment to the end of treatment at 3 months
Change in visceral fat area
visceral fat area was measured to assess changes in body composition following the intervention.
Measured: From enrollment to the end of treatment at 3 months
Change in energy intake
Energy intake was assessed to evaluate changes in dietary intake following the intervention.
Measured: From enrollment to the end of treatment at 3 months
Change in dietary fiber intake
Dietary fiber intake was assessed to evaluate changes in dietary quality following the intervention.
Measured: From enrollment to the end of treatment at 3 months
Change in fasting glucose
Fasting glucose was measured to assess the effect of the intervention on glycemic status.
Measured: From enrollment to the end of treatment at 3 months
Change in HbA1c
HbA1c was measured to assess the effect of the intervention on glycemic status.
Measured: From enrollment to the end of treatment at 3 months
Change in fasting insulin
Fasting insulin was measured to assess the effect of the intervention on insulin status.
Measured: From enrollment to the end of treatment at 3 months
Change in triglycerides
Triglyceride levels were measured to assess the effect of the intervention on lipid metabolism.
Measured: From enrollment to the end of treatment at 3 months
Change in HDL-cholesterol
HDL-cholesterol was measured to assess the effect of the intervention on lipid profile.
Measured: From enrollment to the end of treatment at 3 months
Change in LDL-cholesterol
LDL-cholesterol was measured to assess the effect of the intervention on lipid profile.
Measured: From enrollment to the end of treatment at 3 months
Change in alanine aminotransferase
Alanine aminotransferase was measured to assess the effect of the intervention on liver function.
Measured: From enrollment to the end of treatment at 3 months
Change in aspartate aminotransferase
Aspartate aminotransferase was measured to assess the effect of the intervention on liver function.
Measured: From enrollment to the end of treatment at 3 months
Change in FibroScan liver stiffness measurement (E, kPa)
FibroScan liver stiffness measurement was assessed to evaluate changes in liver stiffness following the intervention.
Measured: From enrollment to the end of treatment at 3 months
Change in FibroScan controlled attenuation parameter (CAP, dB/m)
FibroScan controlled attenuation parameter was assessed to evaluate changes in hepatic steatosis following the intervention.
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start13 Aug 2021
- Primary completion13 Jun 2022
- Study completion5 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shih Chien University
- Sponsor type
- University, hospital or other
- Collaborators
- Changhua Christian Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524621
- Sponsor's protocol ID
- 210607
- Other IDs
- 110-CCH-IRP-063
- Status last verified
- Apr 2026
- First submitted
- 18 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Nutrition Education and Rice Bran Supplementation on Metabolic Dysfunction-associated Steatotic Liver Disease
- ClinicalTrials.gov ID
- NCT07524621
- Acronym / sponsor ID
- 210607
- Keywords
- MASLD, Rice Bran, Nutrition Education, Liver Steatosis, Functional Food, Body Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Shih Chien UniversityUniversity, hospital or other
- Collaborators
- Changhua Christian Hospital
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 5 Aug 2023 (actual)
- First posted
- 13 Apr 2026 (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.
This study aims to evaluate the effects of nutrition education with or without rice bran supplementation in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Participants were recruited from the Division of Gastroenterology and Hepatology at Changhua Christian Hospital and assigned to either a nutrition education (NE) group or a nutrition education plus rice bran (NERB) group. The intervention was conducted for a specified study period, during which participants received dietary guidance and follow-up assessments.
The primary objective of this study is to determine whether rice bran supplementation in addition to nutrition education provides greater benefits on body weight, body mass index, dietary intake, and metabolic parameters compared with nutrition education alone. Secondary outcomes include changes in liver-related biochemical markers, glycemic indicators, lipid profiles, and other anthropometric measurements.
This study may provide evidence on the potential role of rice bran as a functional dietary supplement for improving metabolic health in patients with MASLD and may support the development of practical nutritional strategies for disease management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NE Group | Active comparator | Behavioral: Nutrition EducationParticipants in this arm received structured nutrition education during the study period. |
| NERB Group | Experimental | Behavioral: Nutrition Education, Dietary Supplement: Rice BranParticipants received structured nutrition education together with rice bran supplementation during the intervention period. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- overweight or obese (BMI > 24 kg/m²)
- diagnosed by a physician with moderate fatty liver (grade II)
Key exclusion criteria (5 listed)
- had stage 3 or higher chronic kidney disease
- were undergoing treatment for malignant disease
- had hepatitis B or hepatitis C infection or carrier status
- had alcoholic hepatitis
- had a known allergy to rice bran.
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 |
|---|---|---|
| Nutrition EducationParticipants received structured nutrition education during the study period. | Behavioural | NE Group, NERB Group |
| Rice BranParticipants received structured nutrition education together with rice bran supplementation during the intervention period. | Dietary supplement | NERB Group |
Primary outcome
Change in body weight
Time frame: From enrollment to the end of treatment at 3 months
Body weight was measured to evaluate the effect of nutrition education with or without rice bran supplementation.
16 secondary outcomes
Change in body mass index
Time frame: From enrollment to the end of treatment at 3 months
Change in waist circumference
Time frame: From enrollment to the end of treatment at 3 months
Change in body fat percentage
Time frame: From enrollment to the end of treatment at 3 months
Change in visceral fat area
Time frame: From enrollment to the end of treatment at 3 months
Change in energy intake
Time frame: From enrollment to the end of treatment at 3 months
Change in dietary fiber intake
Time frame: From enrollment to the end of treatment at 3 months
Change in fasting glucose
Time frame: From enrollment to the end of treatment at 3 months
Change in HbA1c
Time frame: From enrollment to the end of treatment at 3 months
Change in fasting insulin
Time frame: From enrollment to the end of treatment at 3 months
Change in triglycerides
Time frame: From enrollment to the end of treatment at 3 months
Change in HDL-cholesterol
Time frame: From enrollment to the end of treatment at 3 months
Change in LDL-cholesterol
Time frame: From enrollment to the end of treatment at 3 months
Change in alanine aminotransferase
Time frame: From enrollment to the end of treatment at 3 months
Change in aspartate aminotransferase
Time frame: From enrollment to the end of treatment at 3 months
Change in FibroScan liver stiffness measurement (E, kPa)
Time frame: From enrollment to the end of treatment at 3 months
Change in FibroScan controlled attenuation parameter (CAP, dB/m)
Time frame: From enrollment to the end of treatment at 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 13 Apr 2026.
- Individual participant dataSharing planned: No
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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 Nutrition Education and Rice Bran in people with Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Shih Chien University at 1 site in Taiwan.
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 2 inclusion and 5 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 13 Apr 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 Taiwan. 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. 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?
Change in body weight (time frame: From enrollment to the end of treatment at 3 months). 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 13 Apr 2026.