Muscle Energy Metabolism and Metabolic Flexibility in Older Men and Women



Status:Recruiting
Healthy:No
Age Range:65 - Any
Updated:4/4/2019
Start Date:November 14, 2018
End Date:June 2019
Contact:Kristen DeLuca, MS, RDN
Email:kristen.deluca@abbott.com
Phone:614-624-5455

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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.


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
We found this trial at
1
site
1400 R Street
Lincoln, Nebraska 68588
Principal Investigator: Joel Cramer, PhD
?
mi
from
Lincoln, NE
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