About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Known allergy to whey protein.
Severe renal dysfunction.
Trial design
Parallel
Treatments tested in this trial
Whey Protein Supplementation Group
Other interventionParticipants will receive standardized basic nutritional support and 20 g of whey protein orally once daily for 6 weeks.
Resistance Training Group
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in Appendicular Skeletal Muscle Mass Index
Locations
Sponsors and contacts
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Wang Xinying
Lead sponsor
Jinling Hospital, China
Sponsor institution
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