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临床试验/NCT05860088
NCT05860088已完成不适用

The Effect of Beta-Alanine and Carnosine From Beef Intake on Muscle Fatigue in Older Adults

Indiana University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年7月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Change in 6-minute walk

研究概览

简要总结

The goal of this controlled-feeding cross-over diet intervention is to compare a beef diet to a vegetarian diet on muscle fatigue in older adults. The aims are:

AIM 1: To test the hypothesis that muscle fatigue is attenuated in older adults consuming beef compared to older adults consuming a plant-based diet.

AIM2: To test the hypothesis that daily beef consumption improves biochemical indicators related to muscle fatigue.

Participants will be randomized to consume either a beef-based diet or vegetarian diet under controlled-feeding conditions for 8 weeks. After a 2-week washout period, participants will cross-over to consume either the beef diet or vegetarian diet for 8 weeks. Body composition and functional muscle outcomes will be measured during each 8-week feeding period. Blood samples will also be collected.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 60-85 years
  • Ability to eat study diet meals for a total of 16 weeks
  • Ability to perform sit-to-stand chair and 6-minute walking tests based on results from PAR-Q questionnaire
  • Ability to provide fasted blood samples
  • Access to transportation
  • Willing to abstain from alcohol consumption and/or use illicit drug use for each 8-week intervention period
  • Ability to consent to participating in this study
  • English-speaking
  • Body mass index between 18.5 (normal) and 39.9 (obese) kg/m2
  • Minimum total body weight of 110 pounds
  • Non-anemia hemoglobin values: Females - >12.0 grams/dL; Men - >13.0 grams/dL
  • Able to ambulate without assistance
  • Physician's clearance for study participation (required prior to baseline testing)

排除标准

  • Inability or refusal to sign the informed consent
  • Significant orthopedic limitations or other contraindications to exercise
  • Inability or refusal to perform muscle fatigue tests
  • Has dietary restrictions that prevent to consumption of beef, soy and/or wheat
  • Has liver or kidney complications
  • Live or work >25 miles from Bloomington study site or does not have transportation to the study site
  • Anticipate elective surgery during the study period
  • Diagnosis of progressive neurological disorders, musculoskeletal disorders, osteoarthritis, rheumatoid arthritis
  • Fracture or serious injury in the last 6 months
  • Stroke, revascularization, deep vein thrombosis, or pulmonary embolism in the past 12 months
  • Severe cardiovascular disease, uncontrolled systemic hypertension, chronic pulmonary disease
  • Plan to move residence or travel out of the local area during the study period
  • Current use of anti-coagulants (e.g. Coumadin or Warfarin)
  • Current use of prescription medications that affect heart rate or blood vessel dilation
  • Psychological or social characteristics that would interfere with their ability to fully participate in the study

研究组 & 干预措施

Beef Diet

Experimental

Participants will be randomized to consume the beef diet for 8 weeks. After a 2-week period, participants will cross-over to consume the vegetarian diet for 8 weeks.

干预措施: Beef Diet (Other)

Vegetarian Diet

Experimental

Participants will be randomized to consume the vegetarian diet for 8 weeks. After a 2-week period, participants will cross-over to consume the beef diet for 8 weeks.

干预措施: Vegetarian Diet (Other)

结局指标

主要结局

Change in 6-minute walk

时间窗: Weeks 0, 4, 8

The change in muscle strength observed in each diet condition will be evaluated through the 6-Minute-Walk-Test. The distance walked by a participant during the 6 minute test period will be recorded.

Adherence to Study Diets

时间窗: Through study completion, approximately 16 weeks

Participant adherence to the study diets will be evaluated.

Change in Sit-to-Stand Chair Test

时间窗: Weeks 0, 4, 8

The change in muscle strength observed in each diet condition will be evaluated through the Sit-To-Stand Chair Test. The number of times a participant comes to a full standing position (from a seated position) in 60 seconds will be recorded.

Retention of Participants

时间窗: Through study completion, approximately 16 weeks

The percentage of randomized participants completing the 16-week diet intervention trial.

次要结局

  • Change in Amino Acids(Weeks 0, 4, 8)
  • Change in Lactate(Weeks 0, 4, 8)
  • Change in Carnosine(Weeks 0, 4, 8)
  • Change in Beta-Alanine(Weeks 0, 4, 8)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cydne Perry

Assistant Professor Applied Health Sciences

Indiana University

研究点 (2)

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