Actively Recruiting

Phase 1
Age: 20Years - 100Years
All Genders
Healthy Volunteers
ID05366933

B-Complex: A Nutraceutical SANS Countermeasure to Reduce Optic Disc Edema in Astronauts During Long-Duration Spaceflight

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

16

Participants Needed

1

Research Sites

274 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

Researchers are evaluating a daily nutraceutical supplement containing bioactive B vitamins to reduce optic disc edema in astronauts during long-duration space missions. This study focuses on optimizing the one-carbon metabolic pathway to improve enzyme function, enhance blood vessel health, strengthen eye tissue elasticity, and reduce retinal thickness changes. The investigation aims to better understand causes of optic disc edema and the effects of this nutritional countermeasure compared to astronauts who did not use supplements. Participants will take a vitamin B-complex supplement before, during, and after a 6 to 12 month spaceflight on the International Space Station. This supplement includes 5-methyltetrahydrofolate, riboflavin 5 phosphate, pyridoxal phosphate, and methylcobalamin. Blood samples are collected multiple times before, during, and after flight to assess vitamin levels, biochemistry, and genetic markers. Eye scans using optical coherence tomography and blood flow measurements will monitor ocular and vascular health. Throughout the study, participants will undergo various tests including blood draws, skin scans for advanced glycation end products, and fingertip temperature assessments to evaluate vascular function. Dietary intake, exercise logs, and medication use will be reviewed. The main outcome is measuring optic disc edema over six months, along with secondary measures of endothelial function, vitamin statuses, oxidative stress markers, and other biochemical indicators. The study lasts throughout the flight and follow-up periods to monitor ongoing effects.

CONDITIONS

Brief 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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 6 to 12 months

Participants take a vitamin B-complex supplement before, during, and after their spaceflight mission on the International Space Station lasting 6 to 12 months.

Visits for blood sample collection and assessments occur approximately 180 days and 45 days before flight, on flight day 90, 30 days before landing, 0 to 2 days after return to Earth, and 30 days after landing.

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

E

Eden Fields

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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Published Research Related To This Trial

Association of Genetics and B Vitamin Status With the Magnitude of Optic Disc Edema During 30-Day Strict Head-Down Tilt Bed Rest.

Sara R Zwart, Steven S Laurie, John J Chen...

https://pubmed.ncbi.nlm.nih.gov/31415055

Effects of short-term mild hypercapnia during head-down tilt on intracranial pressure and ocular structures in healthy human subjects.

Steven S Laurie, Gianmarco Vizzeri, Giovanni Taibbi...

https://pubmed.ncbi.nlm.nih.gov/28611153