ClinicalTrials.Veeva

Menu

Translational Control of Anabolic Resistance in Aging Muscle

Utah System of Higher Education (USHE) logo

Utah System of Higher Education (USHE)

Status

Completed

Conditions

Physical Inactivity

Treatments

Other: Reduced Physical Activity

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03839628
R21AR073422 (U.S. NIH Grant/Contract)
Leucine study

Details and patient eligibility

About

This is an interventional study enrolling older individuals aged 60-85y to observe changes during physical inactivity. This study is investigating the relation between short-term physical inactivity and the impact of muscle health and function. The enrollment goal is 8 participants. The study will occur over the course of a month where participants will undergo testing before and after a reduction in physically activity levels. There will be a screening event collecting baseline data, two body composition scans, muscle function and oral glucose tolerance tests and a metabolic study before and after a 2-week period of inactivity. Each metabolic study will entail three-muscle biopsies: one before and 2 after the ingestion of leucine.

Full description

Pre-testing- The baseline evaluation will assess muscle function and strength, and an oral glucose tolerance test. After the baseline visit, participants will be provided with a step activity monitor to track their level of activity. This will provide a baseline of the participant's normal level of physical activity so an accurate level of 75% activity reduction can be determined. A 3-day daily dietary diary will be provided for the participant to self-report prior to the experiment, as well.

Day 1- After the participant completes their normal activity log and dietary diary, they will be asked to return to the research center for a body composition scan and a metabolic study.

The metabolic study will involve blood sampling from an arm vein and muscle biopsies from the thigh before and after a leucine drink.

2-week period of inactivity- After the metabolic study, the participant will return home and maintain a reduced level of activity (75% reduction) for a two-week period. During this time, the participant will receive phone calls from research personnel in order to maintain adherence to the intervention.

Day 14- After the 2-week reduced activity period, the participant will return to the research center to receive a body composition scan and undergo a metabolic study identical to 'Day 1'.

Post-testing- After Day 14, the participant will be asked to return once again to the research center for a oral glucose tolerance test and the exercise lab for muscle function testing.

Enrollment

9 patients

Sex

All

Ages

60 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age between 60-85 years
  • Ability to sign informed consent
  • Free-living, prior to admission

Exclusion criteria

  • Cardiac abnormalities considered exclusionary by the study physician (e.g., Chronic heart Failure, right-to-left shunt)
  • Uncontrolled endocrine or metabolic disease (e.g., hypo/hyperthyroidism, diabetes)
  • History of kidney disease or failure
  • Vascular disease or risk factors of peripheral atherosclerosis. (e.g., uncontrolled hypertension, obesity, diabetes, hypercholesterolemia > 250 mg/dl, claudication or evidence of venous or arterial insufficiency upon palpitation of femoral, popliteal and pedal arteries)
  • Risk of blood clotting including family history of thrombophilia, pulmonary emboli, myeloproliferative diseases including polycythemia (Hb>18 g/dL) or thrombocytosis (platelets>400x103/mL), and connective tissue diseases (positive lupus anticoagulant), hyperhomocystinemia, deficiencies of factor V Leiden, proteins S and C, and antithrombine III
  • Use of anticoagulant therapy (e.g., Coumadin, heparin)
  • Elevated systolic pressure >150 or a diastolic blood pressure > 100
  • Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma
  • Implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)
  • Currently on a weight-loss diet or body mass index > 30 kg/m2
  • Chronic systemic corticosteroid use (≥ 2 weeks) within 4 weeks of enrollment and for study duration (intra-articular/topical/inhaled therapeutic or physiologic doses of corticosteroids are permitted). Androgens or growth hormone within 6 months of enrollment and for study duration (topical physiologic androgen replacement is permitted)
  • History of stroke with motor disability
  • A recent history (<12 months) of GI bleed
  • History of liver disease
  • History of respiratory disease (acute upper respiratory infection, history of chronic lung disease)
  • Prior history of Heparin-Induced Thrombocytopenia
  • An HbA1c value at or greater than 6.5%
  • Any other condition or event considered exclusionary by the PI and faculty physician

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

Reduced Physical Activity
Experimental group
Description:
Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity
Treatment:
Other: Reduced Physical Activity

Trial documents
1

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems