Muscle Energy Metabolism and Metabolic Flexibility in Older Men and Women

NCT03701867 | Completed

• 1 other identifier: BL39
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Energy Metabolism

Outcome Measures

Primary Outcomes (1)

• Respiratory Quotient

  Ratio of macronutrient oxidation

  Baseline to 270 minutes

Secondary Outcomes (6)

• Blood Biochemistries - Glucose

  Baseline to 270 minutes

• Blood Biochemistries - Insulin

  Baseline to 270 minutes

• Blood Biochemistries - Amino Acids

  Baseline to 270 minutes

• Blood Biochemistries - Fatty Acids

  Baseline to 270 minutes

• Muscle Oxygenation

  Baseline to 270 minutes

Study Arms (1)

Metabolic Flexibility Tests Group

EXPERIMENTAL

Other: Metabolic Flexibility Tests

Interventions

Metabolic Flexibility Tests OTHER

Energy Metabolism, Oxygenation, Body Composition, Blood Samples

Metabolic Flexibility Tests Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (1)

University of Nebraska

Lincoln, Nebraska, 68508, United States

Location

Related Publications (2)

• 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.

  PMID: 41070343 DERIVED

• 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.

  PMID: 35178889 DERIVED

Study Officials

• Vikkie Mustad, PhD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: October 10, 2018
• Study Start: November 14, 2018
• Primary Completion: July 22, 2019
• Study Completion: July 22, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

US (1)