The Effect of a Personalized Protein- and Energy-optimized Diet on Muscle Strength in Adult Patients With Chronic Liver Disease
A legfontosabb adatok
- Ki végzi
- University of Roma La Sapienza
- Hol
- Olaszország1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Befejeződött
- Résztvevők
- 70 fő vett részt
- Kezdés
- 2023. márc. 7.
- Befejezés
- 2025. okt. 20.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Individualized diet
- A regiszteradat frissítve
- 2026. június 4.
Ki vehet részt
- Életkor
- 18 év – 75 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 9 feltétel megnézéseKevesebb
Ki vehet részt
- Outpatients who were clinically stable at the time of enrolment
- Child-Turcotte-Pugh (CTP) score ≤ 10
Ki nem vehet részt
- Already receiving a structured nutrition intervention program or high-protein supplementation
- History of chronic or recurrent hepatic encephalopathy
- Presence of other severe co-morbidities that could confound outcomes
- Active alcohol consumption at the time of screening
- Expected poor compliance with study procedures
- Refusal to provide consent for participation
- Pregnant or lactating women
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
Liver cirrhosis can lead to weakness, frailty, and poor quality of life, even in patients whose disease is still in a relatively stable phase. Many people with cirrhosis have low muscle strength and frailty, but these problems often go unrecognised and untreated. This study is testing whether a personalised diet plan, focused on adequate calories and protein from regular foods, together with nutrition counselling, can improve muscle strength, frailty, and quality of life in outpatients with stable cirrhosis.
A teljes eredeti leírásKevesebb
In this study, about 70 adults with compensated or early decompensated liver cirrhosis are randomly assigned to one of two groups. One group receives an individualised, food-based meal plan designed to provide about 30-35 kilocalories per kilogram per day and 1.2-1.5 grams of protein per kilogram per day, along with regular counselling by a diet professional. The other group continues with their usual medical care and does not receive a specific diet plan. No nutritional supplements are used.
Participants are followed for 16 weeks. During this time, the research team measures handgrip strength as the main outcome, and also assesses frailty and health-related quality of life using standard questionnaires and tests. The goal is to find out whether an individualised dietary intervention, using only food-based strategies and counselling, can safely help maintain or improve muscle strength, reduce frailty, and enhance quality of life in people living with liver cirrhosis.
A vizsgálat 2 csoportja
- Intervention GroupMár használt kezelés, összehasonlításként
Patients received personalized dietary charts tailored to provide an energy intake of 30-35 kcal/kg/day. In overweight or obese individuals, a moderately hypocaloric diet (-500 to -800 kcal/day) was prescribed, consistent with established international guidelines. Protein intake was targeted at 1.2-1.5 g/kg ideal body weight (IBW)/day, with a macronutrient distribution of approximately 55-60% carbohydrates, 20% protein, and 20-25% fat. In addition, patients received structured nutritional counselling at enrolment, which reinforced dietary goals and strategies for adherence.
Kezelés: Individualized diet
- Control GroupNincs vizsgálati kezelés, összehasonlításként
Patients in the control group did not receive any individualized dietary prescriptions or structured nutritional counselling. They continued their routine clinical management as per standard care.
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- The Effect of Dietary Intervention on Muscle Strength in Patients With Liver Cirrhosis
- A regiszteradat frissítve
- 2026. június 4.