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临床试验/NCT04026607
NCT04026607已完成不适用

Efficacy of Higher Versus Lower Quality Protein Supplementation to Support Increased Muscle Protein Synthesis in Older Men

McMaster University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Integrated Muscle Protein Synthesis

研究概览

简要总结

The age-related decline in muscle mass and strength is collectively referred to as sarcopenia. Canadian recommended daily allowance (RDA) for protein intake (0.8 g/kg/d), however, many expert groups have advocated that older persons should increase their daily intake to ~1.2 g/kg/d to support the preservation of muscle mass. The use of plant-based proteins in food formulation has recently become of interest. This study will examine the impact of consuming higher- versus lower-quality protein supplements on muscle protein synthesis in healthy older men.

详细描述

This study will examine the impact of consuming higher- versus lower-quality protein supplements on the integrated rates of muscle protein synthesis in healthy older men. Briefly, participants will consume dietary protein at the RDA for the entire duration of the protocol (2 weeks). Participants will be randomized to consuming collagen (control - CON), whey (WHEY), or pea (PEA) protein supplements twice daily for one week. We will examine the ability of different qualities of protein supplements to stimulate integrated rates of muscle protein synthesis.

研究设计

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

盲法说明

Participants and the investigators will be blinded to the supplement type, only the Lead Principal Investigator will have the codes to decipher the supplement type. Supplements are referred to as A, B and C.

入排标准

年龄范围
65 Years 至 80 Years(Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Men, between the ages of 65 - 80 years (inclusive)
  • Willing and able to provide informed consent
  • Be in general good health, non-smoking
  • Have a body mass index (BMI) between 20-38 kg/m2 (inclusive)

排除标准

  • Use of tobacco or related products.
  • Veganism or vegetarianism
  • Any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements.
  • Use assistive walking devices (e.g., cane or walker)
  • History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years.
  • Significant orthopedic, cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude oral protein supplement ingestion and/or assessment of safety and study objectives.
  • Any cachexia-related condition (e.g., relating to cancer, tuberculosis or human immunodeficiency virus infection and acquired immune deficiency syndrome) or any genetic muscle diseases or disorders
  • Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing)
  • Hypersensitivity or known allergy to any of the components in the test formulations.
  • Excessive alcohol consumption (>21 units/week)
  • History of bleeding diathesis, platelet or coagulation disorders, or antiplatelet/anticoagulation therapy (up to 81mg of baby aspirin per day taken as a prophylactic is permitted).
  • History of statin myalgia.
  • Personal or family history of clotting disorder or deep vein thrombosis;
  • Routine/daily usage of non-steroidal anti-inflammatory drugs (NSAIDS, prescription use or daily use of over the counter medication), use of corticosteroids, testosterone replacement therapy (ingestion, injection, or transdermal), any anabolic steroid, creatine, whey protein supplements, casein or branched-chain amino acids (BCAAs) within 45 days prior to screening.

结局指标

主要结局

Integrated Muscle Protein Synthesis

时间窗: 7 days x 2

Integrated protein synthesis will be determined during 7 days of consuming the RDA of protein (control phase), and during 7 days of supplementation with a randomised protein supplement (Supplement phase). Integrated rates of muscle protein synthesis (MPS) will be determined using the D2O method. Briefly, 2H enrichment of saliva (precursor) and muscle (product) pools (relative to 1H) will be determined using isotope ratio mass spectrometry and 'myofibrillar fractional synthetic rate' (%/day) determined.

次要结局

  • Anabolic Signalling Proteins(1 hour)

研究者

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

Stuart Phillips

Professor

McMaster University

研究点 (2)

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