The Impact of Nutrition Education and Rice Bran Supplementation on Metabolic Dysfunction-associated Steatotic Liver Disease

NCT07524621 | Completed

• 2 other identifiers: 210607110-CCH-IRP-063
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

Keywords

MASLD; Rice Bran; Nutrition Education; Liver Steatosis; Functional Food; Body Weight

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Body weight was measured to evaluate the effect of nutrition education with or without rice bran supplementation.

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (16)

• Change in body mass index

  From enrollment to the end of treatment at 3 months

• Change in waist circumference

  From enrollment to the end of treatment at 3 months

• Change in body fat percentage

  From enrollment to the end of treatment at 3 months

• Change in visceral fat area

  From enrollment to the end of treatment at 3 months

• Change in energy intake

  From enrollment to the end of treatment at 3 months

Study Arms (2)

NE Group

ACTIVE COMPARATOR

Participants in this arm received structured nutrition education during the study period.

Behavioral: Nutrition Education

NERB Group

EXPERIMENTAL

Participants received structured nutrition education together with rice bran supplementation during the intervention period.

Behavioral: Nutrition Education; Dietary Supplement: Rice Bran

Interventions

Nutrition Education BEHAVIORAL

Participants received structured nutrition education during the study period.

NE Group; NERB Group

Rice Bran DIETARY_SUPPLEMENT

Participants received structured nutrition education together with rice bran supplementation during the intervention period.

NERB Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• overweight or obese (BMI \> 24 kg/m²)
• diagnosed by a physician with moderate fatty liver (grade II)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shih Chien University: lead
• Changhua Christian Hospital: collaborator

Study Sites (1)

Shih Chien University

Taipei, 104, Taiwan

Location

MeSH Terms

Conditions

Fatty Liver; Body Weight

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: April 13, 2026
• Study Start: August 13, 2021
• Primary Completion: June 13, 2022
• Study Completion: August 5, 2023
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)