NCT03701867已完成不适用
A Pilot Study to Explore Muscle Energy Metabolism and Metabolic Flexibility in Older Men and Women
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Respiratory Quotient
研究概览
简要总结
This study will explore differences in energy metabolism and metabolic flexibility under various conditions in older men and women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) >20.0 and <39.0 kg/m2
- •Ambulatory (may use assistance device e.g., cane, walker)
- •Not a current smoker (within past 10 years)
- •Low or moderate risk based on the responses from the AHA/ACSM Health/Fitness Facility Preparticipation Screening Questionnaire
- •Normal muscle mass and strength/performance or sarcopenia included in low muscle mass and low grip strength
- •If on thyroid medication or hormone replacement therapy, has been on a constant dosage for at least 2 months prior to Screening Visit
- •Willingness to follow protocol as described
- •Voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB) prior to any participation in the study
排除标准
- •Active/treated disease, under the care of a physician, for the following: metabolic/endocrine (diabetes), hepatic, or renal disease, myocardial infarction, peripheral vascular disease, respiratory or neuromuscular disease
- •Participates in a resistance exercise program
- •Poor appetite with recent unexplained weight loss over the past 6 months
- •Current infection (requiring medication or which might be expected to require hospitalization); has had inpatient surgery, or corticosteroid treatment (excluding topical creams) in the last 3 months or antibiotics in the last 3 weeks.
- •Active malignancy, excluding carcinoma in-situ of the cervix, cutaneous malignancies (basal cell carcinoma, squamous cell carcinoma, except melanoma)
- •Chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis A, B or C, or HIV
- •Taking medications/dietary supplements or substances that could profoundly modulate metabolism in the opinion of the principal investigator or study physician, Exceptions for multi-vitamin/mineral supplement, topical or optical steroids and short-term use (less than two weeks) of dexamethasone
- •Allergy or intolerance to any foods
- •History of gastrointestinal disease, or surgeries, gastroparesis, or taking medications that are known in the opinion of the PI or study physician to interfere with consumption/digestion/absorption of nutrients
- •Eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with compliance with study protocol procedures in the opinion of the principal investigator or study physician
- •Participant in a concomitant AN trial or trial of a non-registered drug (or is within the 30 day follow-up period for such a trial) or that otherwise conflicts with this study unless otherwise approved
结局指标
主要结局
Respiratory Quotient
时间窗: Baseline to 270 minutes
Ratio of macronutrient oxidation
次要结局
- Blood Biochemistries - Insulin(Baseline to 270 minutes)
- Muscle Oxygenation(Baseline to 270 minutes)
- Muscle Fatigue(Baseline to 270 minutes)
- Blood Biochemistries - Glucose(Baseline to 270 minutes)
- Blood Biochemistries - Amino Acids(Baseline to 270 minutes)
- Blood Biochemistries - Fatty Acids(Baseline to 270 minutes)
研究者
研究点 (2)
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