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Completed

NCT Number: NCT07524621

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

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.

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Key information

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease Body Weight Digestive System Diseases Fatty Liver Liver Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shih Chien University

Taipei, 104, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Nutrition Education

Behavioral

Participants received structured nutrition education during the study period.

Rice Bran

Dietary Supplement

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in body mass index

    Time frame: From enrollment to the end of treatment at 3 months

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

  2. Change in waist circumference

    Time frame: From enrollment to the end of treatment at 3 months

    Waist circumference was measured to assess changes in central adiposity following the intervention.

  3. Change in body fat percentage

    Time frame: From enrollment to the end of treatment at 3 months

    Body fat percentage was measured to assess changes in body composition following the intervention.

  4. Change in visceral fat area

    Time frame: From enrollment to the end of treatment at 3 months

    visceral fat area was measured to assess changes in body composition following the intervention.

  5. Change in energy intake

    Time frame: From enrollment to the end of treatment at 3 months

    Energy intake was assessed to evaluate changes in dietary intake following the intervention.

  6. Change in dietary fiber intake

    Time frame: From enrollment to the end of treatment at 3 months

    Dietary fiber intake was assessed to evaluate changes in dietary quality following the intervention.

  7. Change in fasting glucose

    Time frame: From enrollment to the end of treatment at 3 months

    Fasting glucose was measured to assess the effect of the intervention on glycemic status.

  8. Change in HbA1c

    Time frame: From enrollment to the end of treatment at 3 months

    HbA1c was measured to assess the effect of the intervention on glycemic status.

  9. Change in fasting insulin

    Time frame: From enrollment to the end of treatment at 3 months

    Fasting insulin was measured to assess the effect of the intervention on insulin status.

  10. Change in triglycerides

    Time frame: From enrollment to the end of treatment at 3 months

    Triglyceride levels were measured to assess the effect of the intervention on lipid metabolism.

  11. Change in HDL-cholesterol

    Time frame: From enrollment to the end of treatment at 3 months

    HDL-cholesterol was measured to assess the effect of the intervention on lipid profile.

  12. Change in LDL-cholesterol

    Time frame: From enrollment to the end of treatment at 3 months

    LDL-cholesterol was measured to assess the effect of the intervention on lipid profile.

  13. Change in alanine aminotransferase

    Time frame: From enrollment to the end of treatment at 3 months

    Alanine aminotransferase was measured to assess the effect of the intervention on liver function.

  14. Change in aspartate aminotransferase

    Time frame: From enrollment to the end of treatment at 3 months

    Aspartate aminotransferase was measured to assess the effect of the intervention on liver function.

  15. Change in FibroScan liver stiffness measurement (E, kPa)

    Time frame: From enrollment to the end of treatment at 3 months

    FibroScan liver stiffness measurement was assessed to evaluate changes in liver stiffness following the intervention.

  16. Change in FibroScan controlled attenuation parameter (CAP, dB/m)

    Time frame: From enrollment to the end of treatment at 3 months

    FibroScan controlled attenuation parameter was assessed to evaluate changes in hepatic steatosis following the intervention.

Sponsors and collaborators

Lead sponsor

Shih Chien University

Other

Collaborators

  • Changhua Christian Hospital

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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