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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Whey Protein Supplementation Group

    Other intervention

    Participants will receive standardized basic nutritional support and 20 g of whey protein orally once daily for 6 weeks.

  • Resistance Training Group

    Other intervention

    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.

Treatment groups

72 Participants
are divided into 4 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: Resistance Training GroupExperimental treatment 1 intervention
Group C: Combined Intervention GroupExperimental treatment 2 interventions
Group D: Whey Protein Supplementation GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Appendicular Skeletal Muscle Mass Index

Time frame
Baseline, Week 6, and Week 8

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wang Xinying

Lead sponsor

Jinling Hospital, China

Sponsor institution

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