Muscle Energy Metabolism and Metabolic Flexibility in Older Men and Women

NCT ID: NCT03701867

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-14

Study Completion Date

2019-07-22

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.

Detailed Description

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Conditions

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Energy Metabolism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Metabolic Flexibility Tests Group

Group Type EXPERIMENTAL

Metabolic Flexibility Tests

Intervention Type OTHER

Energy Metabolism, Oxygenation, Body Composition, Blood Samples

Interventions

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Metabolic Flexibility Tests

Energy Metabolism, Oxygenation, Body Composition, Blood Samples

Intervention Type OTHER

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vikkie Mustad, PhD

Role: STUDY_CHAIR

Abbott Nutrition

Locations

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University of Nebraska

Lincoln, Nebraska, United States

Site Status

Countries

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United States

References

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Shoemaker ME, Pereira SL, Mustad VA, Gillen ZM, McKay BD, Lopez-Pedrosa JM, Rueda R, Cramer JT. A pilot study evaluating differences in muscle tissue saturation and blood flow between older adults with and without sarcopenia. Front Endocrinol (Lausanne). 2025 Aug 13;16:1644712. doi: 10.3389/fendo.2025.1644712. eCollection 2025.

Reference Type DERIVED
PMID: 41070343 (View on PubMed)

Shoemaker ME, Pereira SL, Mustad VA, Gillen ZM, McKay BD, Lopez-Pedrosa JM, Rueda R, Cramer JT. Differences in muscle energy metabolism and metabolic flexibility between sarcopenic and nonsarcopenic older adults. J Cachexia Sarcopenia Muscle. 2022 Apr;13(2):1224-1237. doi: 10.1002/jcsm.12932. Epub 2022 Feb 17.

Reference Type DERIVED
PMID: 35178889 (View on PubMed)

Other Identifiers

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BL39

Identifier Type: -

Identifier Source: org_study_id

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