Muscle Energy Metabolism and Metabolic Flexibility in Older Men and Women

Study Overview
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Brief Summary
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This study will explore differences in energy metabolism and metabolic flexibility under various conditions in older men and women.

Official Title
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A Pilot Study to Explore Muscle Energy Metabolism and Metabolic Flexibility in Older Men and Women

Conditions
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Energy Metabolism

Intervention / Treatment
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* Other: Metabolic Flexibility Tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metabolic Flexibility Tests Group<br> | Other: Metabolic Flexibility Tests<br>* Energy Metabolism, Oxygenation, Body Composition, Blood Samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Quotient | Ratio of macronutrient oxidation | Baseline to 270 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Biochemistries - Glucose | Venous blood sample | Baseline to 270 minutes | 
| Blood Biochemistries - Insulin | Venous blood sample | Baseline to 270 minutes | 
| Blood Biochemistries - Amino Acids | Venous blood sample | Baseline to 270 minutes | 
| Blood Biochemistries - Fatty Acids | Venous blood sample | Baseline to 270 minutes | 
| Muscle Oxygenation | Near Infrared Spectroscopy | Baseline to 270 minutes | 
| Muscle Fatigue | Electromyography | Baseline to 270 minutes |