Evidence map›Paper›PMID 34278044›Full record

ArticleContemporary clinical trials communications2021

Effects of testosterone undecanoate on performance during multi-stressor military operations: A trial protocol for the Optimizing Performance for Soldiers II study.

Alyssa N Varanoske, Melissa N Harris, Callie Hebert, Emily E Howard, Neil M Johannsen, Steven B Heymsfield, Frank L Greenway, Lee M Margolis, Harris R Lieberman, David D Church and 3 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04120363 (A Randomized, Double-blind, Placebo Controlled Trial of Testosterone Undecanoate for Optimizing Physical and Cognitive Performance During Military Operations), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 37% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04120363 phase4completednot on this map

A Randomized, Double-blind, Placebo Controlled Trial of Testosterone Undecanoate for Optimizing Physical and Cognitive Performance During Military Operations (OPS II)

TypeinterventionalSponsorPennington Biomedical Research CenterRan2019 to 2021Enrolled34ConditionsCaloric Restriction, Exercise, SleepArmsTestosterone Undecanoate, Sesame Oil
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 3 institutions in 1 country.

Alyssa N VaranoskeMilitary Nutrition Division, U.S. Army Research Institute of Environmental Medicine, Natick, MA, USA.
Melissa N HarrisPennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.
Callie HebertPennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.
Emily E HowardMilitary Nutrition Division, U.S. Army Research Institute of Environmental Medicine, Natick, MA, USA.
Neil M JohannsenPennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.
Steven B HeymsfieldPennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.
Frank L GreenwayPennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.
Lee M MargolisMilitary Nutrition Division, U.S. Army Research Institute of Environmental Medicine, Natick, MA, USA.
Harris R LiebermanMilitary Nutrition Division, U.S. Army Research Institute of Environmental Medicine, Natick, MA, USA.
David D ChurchDepartment of Geriatrics, Donald W. Reynolds Institute on Aging, Center for Translational Research in Aging & Longevity, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Arny A FerrandoDepartment of Geriatrics, Donald W. Reynolds Institute on Aging, Center for Translational Research in Aging & Longevity, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Jennifer C RoodPennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.
Stefan M PasiakosMilitary Nutrition Division, U.S. Army Research Institute of Environmental Medicine, Natick, MA, USA.
Pennington Biomedical Research Center · USU.S. Army Research Institute of Environmental Medicine · USInstitute on Aging · US

Funding

Tracking & Evaluation CoreU54GM104940 · NIGMS · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · PI JUDD E SHELLITO · 2012 to 2026
$69.1M
Research BaseP30DK072476 · NIDDK · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · PI Sujoy Ghosh · 2005 to 2026
$26.5M
NIDDK NIH HHS P30 DK072476NIGMS NIH HHS U54 GM104940
6 · The paper itself

Abstract

backgroundPreviously, young males administered 200 mg/week of testosterone enanthate during 28 days of energy deficit (EDef) gained lean mass and lost less total mass than controls (Optimizing Performance for Soldiers I study, OPS I). Despite that benefit, physical performance deteriorated similarly in both groups. However, some experimental limitations may have precluded detection of performance benefits, as performance measures employed lacked military relevance, and the EDef employed did not elicit the magnitude of stress typically experienced by Soldiers conducting operations. Additionally, the testosterone administered required weekly injections, elicited supra-physiological concentrations, and marked suppression of endogenous testosterone upon cessation. Therefore, this follow-on study will address those limitations and examine testosterone's efficacy for preserving Solder performance during strenuous operations.

methodsIn OPS II, 32 males will participate in a randomized, placebo-controlled, double-blind trial. After baseline testing, participants will be administered either testosterone undecanoate (750 mg) or placebo before completing four consecutive, 5-day cycles simulating a multi-stressor, sustained military operation (SUSOPS). SUSOPS will consist of two low-stress days (1000 kcal/day exercise-induced EDef; 8 h/night sleep), followed by three high-stress days (3000 kcal/day and 4 h/night). A 23-day recovery period will follow SUSOPS. Military relevant physical performance is the primary outcome. Secondary outcomes include 4-comparment body composition, muscle and whole-body protein turnover, intramuscular mechanisms, biochemistries, and cognitive function/mood.

conclusionsOPS II will determine if testosterone undecanoate safely enhances performance, while attenuating muscle and total mass loss, without impairing cognitive function, during and in recovery from SUSOPS.

trial registrationClinicalTrials.gov Identifier: NCT04120363.

Indexed as

AnabolismAnd hypogonadismBIA, bioelectrical impedance analysisD2O, deuteriumDSMB, data and safety monitoring boardDXA, dual-energy x-ray absorptiometryECW, extracellular waterEDef, energy deficitEIEE, exercise-induced energy expenditureEnergy deficitExerciseFBR, fractional breakdown rateFFM, fat-free massFSR, fractional synthetic rateHR, heart rateHRR, heart rate reserveICW, intracellular waterID, identificationIRB, Institutional Review BoardMRE, MealOptimizing Performance for Soldiers Trial II, PAR-Q+Optimizing Performance for Soldiers Trial I, OPS IIPennington Biomedical Research Center, PLAPhysical Activity Readiness Questionnaire+, PBplacebo experimental group, PSprotein breakdown, PBRCprotein synthesis, Qratings of perceived exertion, SUSOPSReady-to-Eat, OPS Irepetition maximum, RNArespiratory exchange ratio, RMribonucleic acid, RPESkeletal muscleSleep deprivationsustained, multi-stressor military operationsTBW, total body waterTDEE, total daily energy expenditureTDEI, total daily energy intakeTEST, testosterone experimental groupVO2max, maximal cardiorespiratory fitnessVO2peak, peak oxygen uptakeWBGT, wet bulb globe temperaturewhole-body nitrogen flux, RER

Identifiers

PMID34278044
PMCPMC8264529
OpenAlexW3178995729

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.