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临床试验/NCT07759271
NCT07759271尚未招募不适用

Effect of Whey Protein Supplementation Combined With Resistance Training on Muscle Mass in Patients With Intestinal Failure: A Randomized Controlled Trial

Wang Xinying0 个研究点目标入组 72 人开始时间: 2026年8月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
72
主要终点
Change in Appendicular Skeletal Muscle Mass Index

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •Known allergy to whey protein.
  • •Severe renal dysfunction.

研究组 & 干预措施

Control Group

No Intervention

Participants will receive standardized basic nutritional support and usual clinical care without additional whey protein supplementation or protocol-specified resistance training.

Resistance Training Group

Experimental

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.

干预措施: Resistance Training Group (Other)

Combined Intervention Group

Experimental

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.

干预措施: Whey Protein Supplementation Group (Other)

Combined Intervention Group

Experimental

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.

干预措施: Resistance Training Group (Other)

Whey Protein Supplementation Group

Experimental

干预措施: Whey Protein Supplementation Group (Other)

结局指标

主要结局

Change in Appendicular Skeletal Muscle Mass Index

时间窗: Baseline, Week 6, and Week 8

次要结局

未报告次要终点

研究者

发起方
Wang Xinying
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wang Xinying

Professor

Jinling Hospital, China

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