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Intervention study of isocaloric low-carbohydrate high-protein diet combined with aerobic exercise in patients with NAFLD

Intervention study of isocaloric low-carbohydrate high-protein diet combined with aerobic exercise in patients with NAFLD

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055440
Enrollment
Unknown
Registered
2022-01-09
Start date
2019-01-01
Completion date
Unknown
Last updated
2023-01-30

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

Conditions

nonalcoholic fatty liver disease (NAFLD)

Interventions

Group 1:Normal diet
Group 2:Normal diet + aerobic exercise
Group 3:Isocaloric low carbohydrate high protein restricted diet
Group 4:Isocaloric low carbohydrate high protein restricted diet + aerobic exercise

Sponsors

Shanghai Putuo District Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 16-75 years, gender is not limited; 2. Weekly alcohol intake: no more than 210g for men and no more than 70g for women; 3. There are imaging changes of fatty liver in B-ultrasound or CT examination; 4. Exclude viral hepatitis, drug-induced liver disease, autoimmune liver disease and other autoimmune diseases, thyroid disease and other conditions that lead to fatty liver; 5. No history of major gastrointestinal surgery, such as subtotal gastrectomy and gastrointestinal anastomosis, radical colonectomy, small bowel resection, etc., except appendectomy, peptic ulcer perforation repair, etc.; 6. No serious heart, lung, brain, kidney disease and malignant tumor; 7. Exclude women who are pregnant or have the desire to become pregnant in the near future; 8. Those who voluntarily participated in this study and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Combined with extrahepatic fibrotic diseases, including systemic lupus erythematosus, rheumatic diseases, renal failure, chronic obstructive pulmonary disease, tumor diseases, diabetes, etc.; 2. Patients with alcoholic liver disease, cholestatic liver disease, hereditary metabolic liver disease and advanced liver cirrhosis with liver tumor were excluded; 3. Those who are currently or have received anti-hepatic fibrosis therapy or anti-viral therapy in the past, and those who have used enzyme-lowering drugs; 4. With jaundice, ALT and/or AST exceeds the upper limit of normal by 2 times or more; 5. Patients with incomplete clinical data related to this study.

Design outcomes

Primary

MeasureTime frame
blood routine;hepatic function;renal function;blood lipid level;blood glucose;glycosylated hemoglobin;tumor marker;thyroid function;microelement;coagulation function;immunologic function;interleukin;indicators of hepatic fibrosis;

Countries

China

Contacts

Public ContactJiang Yuanye

Shanghai Putuo District Center Hospital

yuanye1014@126.com+86 13816388826

Outcome results

None listed

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