Effect of Whey Protein Supplementation Combined With Resistance Training on Muscle Mass in Patients With Intestinal Failure: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 72
- Primary Endpoint
- Change in Appendicular Skeletal Muscle Mass Index
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control Group
Participants will receive standardized basic nutritional support and usual clinical care without additional whey protein supplementation or protocol-specified resistance training.
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.
Intervention: Resistance Training Group (Other)
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.
Intervention: Whey Protein Supplementation Group (Other)
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.
Intervention: Resistance Training Group (Other)
Whey Protein Supplementation Group
Intervention: Whey Protein Supplementation Group (Other)
Outcomes
Primary Outcomes
Change in Appendicular Skeletal Muscle Mass Index
Time Frame: Baseline, Week 6, and Week 8
Secondary Outcomes
No secondary outcomes reported
Investigators
Wang Xinying
Professor
Jinling Hospital, China