Actively Recruiting

Phase 1
Age: 20Years - 100Years
All Genders
Healthy Volunteers
NCT05366933

B-Complex: A Nutraceutical SANS Countermeasure

Led by National Aeronautics and Space Administration (NASA) · Updated on 2025-05-22

16

Participants Needed

1

Research Sites

530 weeks

Total Duration

On this page

Sponsors

N

National Aeronautics and Space Administration (NASA)

Lead Sponsor

M

Mayo Clinic

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

B-Complex: A Nutraceutical SANS Countermeasure

Who Can Participate

Age: 20Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Must be astronauts selected for 6-12 month missions on the International Space Station
Not Eligible

You will not qualify if you...

  • Subjects taking B-vitamin supplements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Johnson Space Center

Houston, Texas, United States, 77058

Actively Recruiting

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Research Team

S

Sara Zwart, PhD

CONTACT

E

Eden Fields

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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