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临床试验/NCT03808519
NCT03808519终止不适用

Effects of n3 PUFA Supplementation on the Attenuation of Muscle Disuse Atrophy in Older Women

McMaster University2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2019年2月18日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
2
主要终点
Muscle Cross-Sectional Area

研究概览

简要总结

This study will examine the influence of n3 PUFA supplementation on the rate of muscle atrophy in older women undergoing 1 week of unilateral limb immobilization. Assessments in skeletal muscle strength and skeletal muscle volume will also me made before, after and in recovery from immobilization.

详细描述

Biological aging is associated with the loss of skeletal muscle mass and strength resulting in compromised metabolic function and mobility. Throughout life, individuals will also experience periods of reduced physical activity/muscle disuse that independently lower muscle mass and strength accelerating the aging process. More importantly, older adults (especially older women) that experience periods of muscle disuse are unable to recover muscle mass and strength. The losses in muscle mass with aging and disuse are underpinned by feeding-induced declines in rates of muscle protein synthesis. Thus, strategies to enhance muscle protein synthesis could have clinical implications for those who wish to maintain metabolic health and function during times of muscle disuse.

Supplementation with n3 PUFA-enriched fish oil has been shown to potentiate rates of muscle protein synthesis in response to simulated feeding in both younger and older adults. Fish oil supplementation also has been efficacious in enhancing skeletal muscle strength during a period of resistance exercise training. A previous study from our group demonstrated that younger women supplementing with n3 PUFA-enriched fish oil attenuated declines in skeletal muscle mass and strength during 2 weeks of immobilization. However, no study has examined the impact of fish oil supplementation to enhance muscle protein synthesis and offset declines in muscle mass/strength during a period of immobilization in older women.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
55 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Aged 55 - 75 years old
  • non-smoking (for at least 2 years)
  • > 5 years post-menopausal
  • Body mass index (BMI) between 22 and 33 kg/m2
  • Mini-Mental State Exam (MMSE) score > 20
  • Acceptable medications include: Angiotensin Converting Enzyme (ACE), Beta-Blockers, Acetylsalicylic Acid, Calcium Channel blockers, Depression/Anxiety meds, Bisphosphonates (Fosamax®, Didrocal®, Actonel®, Aclasta®).

排除标准

  • Any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigators, would compromise the ability to comply with the study requirements.
  • 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 n-3 PUFA supplement ingestion and/or assessment of safety and study objectives
  • Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing)
  • Participation in a study of an investigational product less than 60 days or 5 half-lives of the investigational product, whichever is longer, before enrollment in this study
  • Hypersensitivity to the test product
  • Excessive alcohol consumption (>21 units/week)
  • Prior gastrointestinal bypass surgery
  • History of bleeding diathesis, platelet or coagulation disorders, or antiplatelet/anticoagulation therapy
  • Personal or family history of clotting disorder or deep vein thrombosis
  • Concomitant use of corticosteroids, testosterone replacement therapy (ingestion, injection, or transdermal), or any anabolic steroid

结局指标

主要结局

Muscle Cross-Sectional Area

时间窗: Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)

Changes in muscle cross-sectional area assessed by ultrasonography

次要结局

  • Integrated rates of muscle protein synthesis(pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days))
  • Skeletal muscle strength(Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days))
  • Endothelial function(Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days))
  • Vascular function(Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days))

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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