NCT02999802

Brief Summary

This research seeks to better understand how cellular and molecular bases of changes associated with aging contribute to decreased function and increased incidence of disease. Specific mechanism in muscle responsible for anabolic resistance - a key component of sarcopenia and frailty - will be identified. The proposed research is relevant to public health because the discovery of new targets for interventions and novel therapeutics to improve muscle strength and function, prevent falls, and reduce physical dependency will improve the healthspan and quality of life in older adults by improving their physical function and ability to remain independent and healthy for a longer period of time.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2016

Completed
Last Updated

June 13, 2018

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

December 9, 2016

Last Update Submit

June 11, 2018

Conditions

Keywords

Nutrient SensingExerciseElderly

Outcome Measures

Primary Outcomes (1)

  • Change in muscle protein synthesis in response to amino acids

    Measurement of the change in muscle protein synthesis in response to amino acids by standard stable isotope method

    Change from baseline to 3 months

Secondary Outcomes (2)

  • Muscle mass

    Change from baseline to 3 months

  • Muscle function

    Change from baseline to 3 months

Study Arms (1)

Exercise

EXPERIMENTAL

Determining the effect of 12 weeks of resistance training exercise on the response of muscle amino acid sensing

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Progressive resistance exercise training

Exercise

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • yrs
  • Stable body weight for at least 1 year
  • Ability to sign consent form:

You may not qualify if:

  • Exercise training (\>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
  • Physical dependence or frailty (impairment in the Activities of Daily Living (ADL), history of falls (\>2/year), or \>5% weight loss in the past year)
  • Significant heart, liver, kidney, blood, or respiratory disease
  • Peripheral vascular disease
  • Diabetes mellitus or other untreated endocrine disease
  • Active cancer
  • Acute infectious disease or history of chronic infections
  • Recent (within 3 months) treatment with anabolic steroids, or prolonged systemic corticosteroids.
  • Alcohol or drug abuse
  • Tobacco use (smoking or chewing)
  • Malnutrition (BMI \< 18.5 kg/sq meter)
  • Obesity (BMI \> 30 kg/sq meter)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UTMB

Galveston, Texas, 77555, United States

Location

Related Publications (1)

  • Moro T, Brightwell CR, Deer RR, Graber TG, Galvan E, Fry CS, Volpi E, Rasmussen BB. Muscle Protein Anabolic Resistance to Essential Amino Acids Does Not Occur in Healthy Older Adults Before or After Resistance Exercise Training. J Nutr. 2018 Jun 1;148(6):900-909. doi: 10.1093/jn/nxy064.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Blake B Rasmussen, PhD

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 9, 2016

First Posted

December 21, 2016

Study Start

October 1, 2015

Primary Completion

December 21, 2016

Study Completion

December 21, 2016

Last Updated

June 13, 2018

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations