NCT00968344

Brief Summary

The investigators will test the following hypotheses:

  1. 1.Bedrest will blunt the anabolic response to a mixed nutrient meal, facilitating a loss of muscle mass and functional capacity that is only partially restored during rehabilitation.
  2. 2.Enriching daily meals with leucine will promote protein synthesis and maintain the anabolic response to mixed nutrient meal ingestion. This will preserve lean muscle mass and function during bedrest and facilitate the recovery of functional and metabolic capacity during rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

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

August 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

May 31, 2019

Completed
Last Updated

May 31, 2019

Status Verified

December 1, 2017

Enrollment Period

5.7 years

First QC Date

August 28, 2009

Results QC Date

December 1, 2017

Last Update Submit

February 14, 2019

Conditions

Muscle Loss

Outcome Measures

Primary Outcomes (1)

  • Lean Leg Mass

    DEXA scan of both legs pre/post bed rest

    At baseline prior to beginning bed rest and after 14 days of bed rest

Study Arms (2)

Leucine

EXPERIMENTAL

3-4 g Leucine added to daily meals during bed rest

Dietary Supplement: Leucine

Placebo

PLACEBO COMPARATOR

3-4 g Alanine added to daily meals during bed rest

Dietary Supplement: Alanine

Interventions

LeucineDIETARY_SUPPLEMENT

3-4g Leucine added to daily meals

Leucine
AlanineDIETARY_SUPPLEMENT

Powered amino acid

Placebo

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 45-60
  • Ability to sign informed consent

You may not qualify if:

  • Subjects with uncontrolled metabolic disease
  • A GFR \<65 mL/min/1.73m2 or evidence of kidney disease or failure
  • Subjects with vascular disease or risk factors of peripheral atherosclerosis
  • Any history of hypo- or hyper-coagulation disorders. (e.g., Coumadin use or history of DVT or PE)
  • Subjects with chronically elevated systolic pressure \>150 or a diastolic blood pressure \> 100
  • Subjects with implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)
  • Subjects with recently (6 months) treated cancer other than basal cell carcinoma
  • Any subject currently on a weight-loss diet or a body mass index \> 30 kg/m2
  • Inability to abstain from smoking for duration of study
  • A history of \> 20 pack per year smoking
  • Any subject that is HIV-seropositive or has active hepatitis
  • Recent anabolic or corticosteroids use (within 3 months)
  • Subjects with hemoglobin or hematocrit lower than accepted lab values
  • Agitation/aggression disorder
  • History of stroke with motor disability
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (1)

  • English KL, Mettler JA, Ellison JB, Mamerow MM, Arentson-Lantz E, Pattarini JM, Ploutz-Snyder R, Sheffield-Moore M, Paddon-Jones D. Leucine partially protects muscle mass and function during bed rest in middle-aged adults. Am J Clin Nutr. 2016 Feb;103(2):465-73. doi: 10.3945/ajcn.115.112359. Epub 2015 Dec 30.

    PMID: 26718415DERIVED

MeSH Terms

Conditions

Muscular Atrophy

Interventions

LeucineAlanine

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Results Point of Contact

Title
Douglas Paddon-Jones, Professor
Organization
University of Texas Medical Branch
djpaddon@utmb.edu
409-772-3073

Study Officials

  • Douglas Paddon-Jones, PhD

    The University of Texas Medical Branch at Galveston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Intervention: leucine
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2009

First Posted

August 31, 2009

Study Start

August 1, 2009

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

May 31, 2019

Results First Posted

May 31, 2019

Record last verified: 2017-12

Locations

US(1)