Effects of Whey Protein and Resistance Training on Muscle Mass in Patients With Intestinal Failure

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWang Xinying

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

Qualifiers

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

Treatments tested in this trial

  • Whey Protein Supplementation Group
  • Resistance Training Group

Treatment groups

72 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Wang Xinying

Lead sponsor

Jinling Hospital, China

Sponsor institution