Trial Outcomes & Findings for Muscle Mass During Space Exploration (NCT NCT00968344)

Results Overview

DEXA scan of both legs pre/post bed rest

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

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

Results posted on

2019-05-31

Participant Flow

2009-2014: we recruited and studied middle-aged men and women (45-60 years), representative of the ethnic makeup of the United States. Volunteers were recreationally active but athletically untrained.After providing written informed consent, volunteers were screened in the UTMB Institute for Translational Sciences-Clinical Research Center.

Participant milestones

Participant milestones
Measure	Leucine 3-4 g Leucine added to daily meals during bed rest Leucine: crystalline amino acid	Placebo 3-4 g Alanine added to daily meals during bed rest Alanine: crystalline amino acid
Overall Study STARTED	20	20
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	10	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Screen fails not included

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Leucine n=10 Participants 3-4 g Leucine added to daily meals during bed rest Leucine: 3-4g Leucine added to daily meals	Placebo n=9 Participants 3-4 g Alanine added to daily meals during bed rest Alanine: Powered amino acid	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=93 Participants	9 Participants n=4 Participants	19 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants • Screen fails not included	3 Participants n=4 Participants • Screen fails not included	7 Participants n=27 Participants • Screen fails not included
Sex: Female, Male Male	6 Participants n=93 Participants • Screen fails not included	6 Participants n=4 Participants • Screen fails not included	12 Participants n=27 Participants • Screen fails not included
Region of Enrollment United States	10 participants n=93 Participants	9 participants n=4 Participants	19 participants n=27 Participants

PRIMARY outcome

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

Population: Healthy community-dwelling men and women aged 45-60 y

DEXA scan of both legs pre/post bed rest

Outcome measures

Outcome measures
Measure	Control Group n=9 Participants Subjects in the control group consumed a 3-4 g of alanine at each meal (an isonitrogenous control)	Leucine (Intervention) Group n=10 Participants Subjects in the leucine group consumed 3-4 g of leucine at each meal during bed rest.
Lean Leg Mass	-1.2 g Standard Error 0.2	-0.9 g Standard Error 0.1

Adverse Events

Leucine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Douglas Paddon-Jones, Professor

University of Texas Medical Branch

Phone: 409-772-3073

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place