RecruitingPhase 1NCT05366933

B-Complex: A Nutraceutical SANS Countermeasure


Sponsor

National Aeronautics and Space Administration (NASA)

Enrollment

16 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

In this project, the investigators propose to test effectiveness of a daily nutraceutical supplement containing bioactive B vitamins to mitigate optic disc edema in astronauts. The proposed countermeasure is intended to maximize functioning of the one-carbon metabolic pathway to provide enough substrate and cofactors to overcome any genetic differences that may impact the efficiency of enzyme function. By optimizing the pathway, this will 1) optimize endothelial function by increasing eNOS coupling and nitric oxide synthesis and 2) optimize collagen firmness and elasticity in the sclera and lamina cribrosa, and 3) minimize changes in total retinal thickness during and after flight. The protocol includes assessments of ocular health and function, along with determinants of vascular endothelial function, advanced glycation end products, and nutritional status and one carbon biochemistry. These additional measures will be critical for the further definition of the causes of optic disc edema in some astronauts after long-duration space flight, and in understanding the effect of the countermeasure. Finally, the supplemented subjects in this study will be compared against total retinal thickness data from previously flown astronauts known to have not taken supplements during their missions.


Eligibility

Min Age: 20 YearsMax Age: 100 Years

Inclusion Criteria1

  • Must be astronauts selected for 6-12 month missions on the International Space Station

Exclusion Criteria1

  • Subjects taking B-vitamin supplements

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGVitamin B-Complex Supplement

Vitamin B-Complex Supplement containing: 5-methyltetrahydrofolate, riboflavin 5 phosphate, pyridoxal phosphate, and methylcobalamin


Locations(1)

Johnson Space Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05366933


Related Trials