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A multicenter pilot clinical trial of resistant starch intervention in MASLD

A multicenter pilot clinical trial of resistant starch intervention in MASLD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074588
Enrollment
Unknown
Registered
2023-08-10
Start date
2023-08-09
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metabolic dysfunction-associated steatotic liver disease

Interventions

experimental group:Resistant starch, 20g, mixed with warm water, taken before meals, twice a day, for a total of 120 days.

Sponsors

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Definitively diagnosed with MASLD; 2. Aged 18-70 years old; 3. Ethnic Chinese; 4. Written informed consents must be obtained.

Exclusion criteria

Exclusion criteria: 1. Participants with diabetes mellitus; 2. Participants with acute or chronic gastrointestinal diseases; 3. Participants with hyperthyroidism, hypothyroidism, chronic kidney disease, severe renal insufficiency, malignant tumor, uncontrolled hypertension or myocardial infarction or heart failure within the past six months; 4. Participants with routine use of prescription medicines or adjuvant Chinese and Western medicines (except regular contraceptives) to treat MASLD; 5. Participants using thyroid hormones, glucocorticoids and other drugs that may affect metabolism; 6. Participants using antibiotics within 3 weeks before the study or regularly using probiotics; 7. Pregnant, breastfeeding women or women planning to get pregnant; 8. Participants expected to have poor compliance; 9. Participants who have used weight-loss medication or participated in weight-loss programs in the previous 3 months; 10. Participants with mental disorders who cannot cooperate; 11. Participants with pacemaker or metallic implants, claustrophobia or other conditions that would be unable to undergo magnetic resonance examinations; 12. Participants have been enrolled in or had been enrolled in another clinical study within 4 weeks before the start of the study.

Design outcomes

Primary

MeasureTime frame
Percent change in intrahepatic triglyceride content;

Secondary

MeasureTime frame
Change in anthropometric indicators;Change in body composition;Glycemic control;Change in insulin sensitivity;Change in liver and renal function;Change in lipid profiles;Change in cytokines;Multi-omics parameters;Change in intrahepatic triglyceride content (IHTC);

Countries

China

Contacts

Public ContactWeiping Jia

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

wpjia@sjtu.edu.cn+86 138 1888 8939

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026