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The Effect of a Personalized Protein- and Energy-optimized Diet on Muscle Strength in Adult Patients With Chronic Liver Disease

1. juni 2026 opdateret af: Saniya Khan, University of Roma La Sapienza

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Italien
    • Lazio
      • Rome, Lazio, Italien, 00185
        • Policlinico Umberto I

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
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.
Andet: Individualized diet

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
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in handgrip strength (kg) from baseline to Week 16 measured using a Hand Dynamometer
Tidsramme: Baseline and 16 weeks

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Roma La Sapienza

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. marts 2023

Primær færdiggørelse (Faktiske)

20. oktober 2025

Studieafslutning (Faktiske)

20. oktober 2025

Datoer for studieregistrering

Først indsendt

18. maj 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 0057/2023

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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Kliniske forsøg med Levercirrhose

Kliniske forsøg med Individualized diet

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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