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

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

Study Overview

• Status: Completed
• Conditions: Energy Metabolism
• Intervention / Treatment: Other: Metabolic Flexibility Tests

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68508
      • University of Nebraska

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Metabolic Flexibility Tests Group	Other: Metabolic Flexibility Tests; Energy Metabolism, Oxygenation, Body Composition, Blood Samples

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abbott Nutrition

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 14, 2018
• Primary Completion (ACTUAL): July 22, 2019
• Study Completion (ACTUAL): July 22, 2019

Study Registration Dates

• First Submitted: September 21, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (ACTUAL): October 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: BL39

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No