Effects of Whey Protein and Resistance Training on Muscle Mass in Patients With Intestinal Failure
Effect of Whey Protein Supplementation Combined With Resistance Training on Muscle Mass in Patients With Intestinal Failure: A Randomized Controlled Trial
This single-center, prospective, four-arm randomized controlled trial will enroll 72 adults with chronic intestinal failure and low muscle mass. All participants will receive standardized basic nutritional support and will be randomly assigned to one of four groups: usual care, whey protein supplementation, resistance training, or whey protein supplementation combined with resistance training.
Participants assigned to whey protein supplementation will receive 20 g of whey protein daily for 6 weeks. Participants assigned to resistance training will complete moderate-intensity resistance exercises for approximately 30 minutes, 3 to 5 times per week, for 6 weeks. Participants in the combined group will receive both interventions.
Body composition, appendicular skeletal muscle mass index, phase angle, handgrip strength, 6-meter walking speed, laboratory indicators, and quality of life will be assessed at baseline, week 6, and week 8. The study aims to evaluate the effectiveness and safety of whey protein supplementation and resistance training, alone or in combination, for improving muscle mass and physical function in patients with chronic intestinal failure.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Patients with chronic intestinal failure and low muscle mass.
- Willing to participate in the study and provide written informed consent.
- Able to complete the assigned 6-week intervention and the assessments at baseline, week 6, and week 8.
Exclusion Criteria:
- Known allergy to whey protein.
- Severe renal dysfunction.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Control Group
Participants will receive standardized basic nutritional support and usual clinical care without additional whey protein supplementation or protocol-specified resistance training.
|
|
|
Eksperimentell: Resistance Training Group
Participants will receive standardized basic nutritional support and moderate-intensity resistance training for approximately 30 minutes per session, 3 to 5 times per week, for 6 weeks.
|
Participants will perform moderate-intensity resistance training for approximately 30 minutes per session, 3 to 5 times per week, for 6 weeks, in addition to standardized basic nutritional support.
|
|
Eksperimentell: Combined Intervention Group
Participants will receive standardized basic nutritional support, 20 g of whey protein orally once daily, and moderate-intensity resistance training for approximately 30 minutes per session, 3 to 5 times per week, for 6 weeks.
|
Participants will perform moderate-intensity resistance training for approximately 30 minutes per session, 3 to 5 times per week, for 6 weeks, in addition to standardized basic nutritional support.
Participants will receive standardized basic nutritional support and 20 g of whey protein orally once daily for 6 weeks.
|
|
Eksperimentell: Whey Protein Supplementation Group
|
Participants will receive standardized basic nutritional support and 20 g of whey protein orally once daily for 6 weeks.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in Appendicular Skeletal Muscle Mass Index
Tidsramme: Baseline, Week 6, and Week 8
|
Baseline, Week 6, and Week 8
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
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
- 2026DZKY-134-01
Legemiddel- og utstyrsinformasjon, studiedokumenter
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