The Effect of a Personalized Protein- and Energy-optimized Diet on Muscle Strength in Adult Patients With Chronic Liver Disease
The Effect of Dietary Intervention on Muscle Strength in Patients With Liver Cirrhosis
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.
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.
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Lazio
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Rome, Lazio, Italia, 00185
- Policlinico Umberto I
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria: ● Confirmed diagnosis of liver cirrhosis based on clinical, biochemical, radiological, and/or histological evidence.
- Outpatients who were clinically stable at the time of enrolment.
- Child-Turcotte-Pugh (CTP) score ≤ 10.
Exclusion Criteria:
- Already receiving a structured nutrition intervention program or high-protein supplementation.
- Presence of other severe co-morbidities that could confound outcomes.
- History of chronic or recurrent hepatic encephalopathy.
- Active alcohol consumption at the time of screening.
- Expected poor compliance with study procedures.
- Refusal to provide consent for participation.
- Pregnant or lactating women.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: Intervention Group
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.
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Energy intake : 30-35 kcal/kg/day (if overweight or obese individuals -500 to -800 kcal/day). Protein intake : 1.2-1.5 g/kg/day |
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Ingen inngripen: Control Group
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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in handgrip strength (kg) from baseline to Week 16 measured using a Hand Dynamometer
Tidsramme: Baseline and 16 weeks
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Muscle strength is assessed using a calibrated Jamar® Hydraulic Hand Dynamometer (Performance Health International Ltd., Nottinghamshire, UK), following standardized protocols. Participants are seated upright with the shoulder adducted, elbow flexed at 90°, and the forearm and wrist in a neutral position. The dynamometer is held in the dominant hand unless contraindicated, in which case the non-dominant hand is used. Each participant is instructed to squeeze the device with maximum effort for a few seconds, with standardized verbal encouragement provided to ensure optimal performance. The average of three measurements are recorded and expressed in kilograms (kg). |
Baseline and 16 weeks
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 0057/2023
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