NCT00872911

Brief Summary

The investigators' general hypothesis is that nutritional factors, including protein/energy malnutrition and/or an impaired response of muscle to nutrition, and inactivity play significant roles in developing sarcopenia, the involuntary loss of muscle mass and function with age. Therefore, age-specific prolonged interventions including nutritional manipulations and/or exercise may help to reduce, stabilize, or even reverse sarcopenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_1

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

March 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

December 12, 2016

Status Verified

December 1, 2016

Enrollment Period

5.8 years

First QC Date

March 27, 2009

Last Update Submit

December 8, 2016

Conditions

Sarcopenia

Keywords

Sarcopenianutritionagingmetabolismexercise

Outcome Measures

Primary Outcomes (1)

  • Muscle mass

    6 months

Secondary Outcomes (2)

  • Muscle function

    6 months

  • muscle protein turnover

    6 months

Study Arms (4)

Nutritional supplement

EXPERIMENTAL
Dietary Supplement: Amino acids

Placebo + Exercise

EXPERIMENTAL
Drug: Exercise

Nutritional Supplement + Exercise

EXPERIMENTAL
Dietary Supplement: Amino acidsDrug: Exercise

Placebo

NO INTERVENTION

Interventions

Amino acidsDIETARY_SUPPLEMENT

mixed pure crystalline amino acids for human use (Ajinomoto), 15 g/d

Nutritional Supplement + ExerciseNutritional supplement
ExerciseDRUG

progressive exercise training

Nutritional Supplement + ExercisePlacebo + Exercise

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • age 65-85 yrs
  • ability to sign consent form (score \>25 on the 30 item Mini Mental State Examination, MMSE)
  • stable body weight for at least 1 year (verified via medical records).

You may not qualify if:

  • physical dependence or frailty (impairment in any of the Activities of Daily Living (ADL), history of falls (≥2/year) or significant weight loss in the past year)
  • exercise training (≥2 weekly sessions of moderate-to-high intensity aerobic or resistance exercise)
  • significant heart, liver, kidney, blood or respiratory disease
  • peripheral vascular disease
  • diabetes or other untreated endocrine disease
  • active cancer
  • recent (within 6 months) treatment with anabolic steroids, or corticosteroids
  • alcohol or drug abuse
  • tobacco use (smoking or chewing, verified via medical records)
  • depression (\>5 on the 15-item Geriatric Depression Scale (GDS))
  • malnutrition (BMI \<20 kg/m2; hypoalbuminemia or hypotransferrenemia; protein intake\<0.66 g/kg/day at run-in)
  • obesity (BMI\>30 kg/m2).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sealy Center on Aging, University of Texas Medical Branch

Galveston, Texas, 77550, United States

Location

Related Publications (2)

  • Randolph AC, Markofski MM, Rasmussen BB, Volpi E. Effect of essential amino acid supplementation and aerobic exercise on insulin sensitivity in healthy older adults: A randomized clinical trial. Clin Nutr. 2020 May;39(5):1371-1378. doi: 10.1016/j.clnu.2019.06.017. Epub 2019 Jun 28.

    PMID: 31307843DERIVED

  • Markofski MM, Jennings K, Timmerman KL, Dickinson JM, Fry CS, Borack MS, Reidy PT, Deer RR, Randolph A, Rasmussen BB, Volpi E. Effect of Aerobic Exercise Training and Essential Amino Acid Supplementation for 24 Weeks on Physical Function, Body Composition, and Muscle Metabolism in Healthy, Independent Older Adults: A Randomized Clinical Trial. J Gerontol A Biol Sci Med Sci. 2019 Sep 15;74(10):1598-1604. doi: 10.1093/gerona/gly109.

    PMID: 29750251DERIVED

MeSH Terms

Conditions

SarcopeniaMotor Activity

Interventions

Amino AcidsExercise

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and ProteinsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Elena Volpi, MD,PhD

    The University of Texas Medical Branch, Galveston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2009

First Posted

March 31, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2014

Study Completion

August 1, 2016

Last Updated

December 12, 2016

Record last verified: 2016-12

Locations

US(1)