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

Registry ID
NCT07759271
Source registry
NCT
Status
NOT_YET_RECRUITING
Phase
NA
Study type
INTERVENTIONAL
Sponsor
Wang Xinying
Enrollment
72
Start date
2026-08-28
Completion date
2027-10-28
Last update
2026-08-12

Conditions

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.

Interventions

Inclusion criteria

Inclusion Criteria: 1. Patients with chronic intestinal failure and low muscle mass. 2. Willing to participate in the study and provide written informed consent. 3. Able to complete the assigned 6-week intervention and the assessments at baseline, week 6, and week 8.

Exclusion criteria

Exclusion Criteria: 1. Known allergy to whey protein. 2. Severe renal dysfunction.

Primary outcomes

[{"measure":"Change in Appendicular Skeletal Muscle Mass Index","timeFrame":"Baseline, Week 6, and Week 8"}]

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