NCT00170144

Brief Summary

With aging, there is a decrease in muscle mass and function especially in the energy storehouses of cells called mitochondria. Amino acids, the building blocks of protein, and insulin have been shown to increase muscle mitochondrial protein synthesis and thereby function. Branched chain amino acids which can only be provided in the diet seem to be key in this process. Therefore in our study, our aim is to study the effect of branched chain amino acids on muscle mitochondrial protein synthesis in both the young and elderly. By doing so, we can then elucidate if branched chain amino acid supplementation has future potential in improving quality of life and performance in the elderly. The study will involve blood sampling and needle muscle biopsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Sep 2005

Typical duration for not_applicable healthy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

March 15, 2011

Status Verified

March 1, 2011

Enrollment Period

1.7 years

First QC Date

September 13, 2005

Last Update Submit

March 14, 2011

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Does branched chain amino acids stimulate muscle mitochondrial ATP production in young and elderly?

Secondary Outcomes (3)

  • Does branched chain amino acids increase abundance of mRNA of genes encoding mitochondrial proteins and transcription factors equally in young and old?

  • Does branched chain amino acids increase levels of phosphorylated signaling proteins through the mTOR pathways equally in the young and old?

  • Does branched chain amino acids increase fractional synthesis rates of specific mitochondrial proteins, mitochondrial protein concentrations and mitochondrial enzyme activities equally in the young and old?

Interventions

Branchamin 4%DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Young (age 18-30) or old (age 65-80) Body mass index \<30

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Amino Acids

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

  • K. Sreekumaran Nair, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

September 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

March 15, 2011

Record last verified: 2011-03

Locations

US(1)