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Muscle Energy Metabolism and Metabolic Flexibility in Older Men and Women

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03701867
Enrollment
22
Registered
2018-10-10
Start date
2018-11-14
Completion date
2019-07-22
Last updated
2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Energy Metabolism

Brief summary

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

Interventions

OTHERMetabolic Flexibility Tests

Energy Metabolism, Oxygenation, Body Composition, Blood Samples

Sponsors

Abbott Nutrition
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Respiratory QuotientBaseline to 270 minutesRatio of macronutrient oxidation

Secondary

MeasureTime frameDescription
Blood Biochemistries - InsulinBaseline to 270 minutesVenous blood sample
Blood Biochemistries - Amino AcidsBaseline to 270 minutesVenous blood sample
Blood Biochemistries - GlucoseBaseline to 270 minutesVenous blood sample
Muscle OxygenationBaseline to 270 minutesNear Infrared Spectroscopy
Muscle FatigueBaseline to 270 minutesElectromyography
Blood Biochemistries - Fatty AcidsBaseline to 270 minutesVenous blood sample

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026