NCT07897981Toboroz1/2. fázis
High-Plant-Protein-Diet or High-Animal-Protein-Diet for Improving Alcoholic Fatty Liver Disease
Efficacy and Safety of a High-Plant-Protein-Diet or High-Animal-Protein-Diet in Patients With Alcoholic Fatty Liver Disease: A Randomized Controlled Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 27.
Rövid összefoglaló (regiszter, angolul)
Alcohol-associated liver disease (ALD) is a major cause of mortality from advanced liver disease, accounting for 47.9% of cirrhosis-related deaths and 30% of hepatocellular carcinoma-related deaths annually. In China, both per capita alcohol consumption and the prevalence of ALD (approximately 5.15%) are on the rise, making ALD an increasingly significant public health burden. Alcohol-associated fatty liver disease (AFLD), the initial and most reversible stage of ALD, is pathologically characterized by excessive hepatic lipid accumulation, mild hepatocellular injury, and low-grade inflammation. It can progress to alcoholic hepatitis, and in some patients, advance to hepatic fibrosis, cirrhosis, or even hepatocellular carcinoma. Currently, there is no established effective pharmacotherapy for AFLD; although alcohol abstinence remains the optimal strategy for disease reversal, sustained abstinence is often difficult to achieve among individuals with alcohol dependence. Dietary protein source may independently influence metabolic health beyond total protein intake. Plant proteins (primarily derived from legumes and cereals) are rich in arginine, glutamine, and fiber-associated bioactive compounds, whereas animal proteins (mainly from dairy and poultry) are abundant in branched-chain amino acids (BCAAs) and sulfur-containing amino acids. Preclinical studies have demonstrated that, compared with animal proteins such as casein, plant proteins more effectively attenuate high-fat- or alcohol-induced hepatic steatosis by upregulating hepatic PPAR-α expression and suppressing SREBP-1c activity. Human intervention studies further suggest that long-term higher intake of plant protein is associated with lower hepatic fat content and reduced risk of insulin resistance. However, no randomized controlled trial has yet directly compared the effects of high-purity plant protein versus animal protein supplementation on clinical outcomes in patients with AFLD under isocaloric and isonitrogenous conditions. Therefore, this study aims to conduct a randomized controlled trial to evaluate the effects of plant protein versus animal protein supplementation within an isocaloric dietary framework on liver function, hepatic fat content, and glucose-lipid metabolism in individuals with AFLD. The findings will elucidate the efficacy and underlying mechanisms of protein-source modulation in ameliorating AFLD, thereby providing population-based evidence and strategic guidance for health promotion in this patient population.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 1/2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 74 (tervezett)
- Első benyújtás
- 2026. okt. 12.
- Kezdés
- 2026. okt. 10.
- Elsődleges befejezés
- 2028. dec. 31.
- Fő szponzor
- Li Lab,MD
- Betegségek
- Zsírmáj (MASLD/MASH)
- NCT-szám
- NCT07897981
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1/2. fázis
- Tervezett résztvevők: 74
- 2026. okt. 10. és az elsődleges befejezés (2028. dec. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Long-term use of medications known to cause hepatic steatosis or steatohepatitis (e.g., amiodarone or tamoxifen), nutritional supplements, or probiotics.
Más betegség
- Presence of other hepatobiliary diseases, such as autoimmune liver disease, viral hepatitis, liver fibrosis, or cirrhosis.
- Presence of severe cardiovascular or cerebrovascular diseases, or renal insufficiency.
- Patients with tumors or other severe systemic diseases.
- Patients with gastrointestinal disorders, or those with known protein allergy or intolerance.
Egyéb
- Average daily ethanol intake >80 g/d.
- Total daily energy intake (excluding energy from alcohol) <1900 kcal or ≥2900 kcal.
- Participation in another interventional study within the past year, or scheduled to receive non-study treatments during the trial period.
Kiket keres a vizsgálat
- Aged between 18 and 74 years old.
- Able to understand the study and voluntarily sign the informed consent form.
- Meet the clinical diagnostic criteria for alcohol-associated fatty liver disease (AFLD): a history of alcohol consumption for ≥5 years, with an average daily ethanol intake of ≥20 g/d; clinically diagnosed with fatty liver (indicated by abdominal ultrasound or a liver MRI proton density fat fraction [MRI-PDFF] ≥5.2%).
Életkor a regiszterben: 18 év – 74 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Zhejiang Chinese Medical University | Hangzhou | Kína | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.