Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05366933

B-Complex: A Nutraceutical SANS Countermeasure

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johnson Space Center

Houston, Texas, 77058, United States

Location status: Recruiting

Location contact

Eden Fields

CONTACT

About this study

Fasting (8-h) blood samples (7.5 mL SST and 5 mL EDTA tubes, 12.5 mL total per session) will be collected approximately 180 days and 45 days before flight, on approximate flight day 90, and 30 days before landing, Return to Earth +0-2 days and 30 days after landing.

Blood samples will be analyzed for vitamin status and one-carbon biochemistry, as previously described. One blood sample (collected before flight) will be analyzed for approximately 511 SNPs matching the profile of testing from our ongoing research related to optic disc edema. Serum samples will be analyzed for biochemistry measures evaluating endothelial function, vitamin status, and oxidative damage.

Nutritional status assessment data, including inflight dietary intake and body mass data, completed for routine medical requirements will be requested for data sharing. Inflight medical exercise log data as well as available standard measures data will also be requested for data sharing. Medication use/Med Logs will also be requested for data sharing.

Vascular function VENDYS-II (Endothelix, Inc) will be used to assess reactive hyperaemia through changes in fingertip temperature. The test consists of an automated blood pressure measurement followed by cuff occlusion of the right arm for 2 to 5 min. During this time, the fingertip temperature in the right hand decreases because of the lack of circulation in the fingertip. After the cuff is released, blood flow resumes, causing a temperature rebound in the fingertip in a manner that is proportional to vascular reactivity.

Advanced Glycation End (AGE) Products Skin autofluorescence (SAF) will be analyzed non-invasively using an AGE reader (Diagnoptics Technologies, Groningen, the Netherlands). The AGE reader illuminates a skin surface of approximately 4 cm2, guarded against surrounding light, with an excitation light source with wavelength between 300 and 429 nm. This method is based on the fluorescent properties of certain AGEs accumulated in dermal tissue.

OCT and OCT-A Optical coherence tomography (OCT) and OCT-angiography (OCT-A) scans will be acquired using the Spectralis OCT2 (Heidelberg Engineering) before, during, and after flight. The scan pattern includes 24 B-scans centered in a radial pattern over the optic nerve head, as well as a 3.5 mm circle scan surrounding the optic nerve head for assessment of retinal nerve fiber layer thickness and choroid thickness. For OCT-A, five consecutive volume scans will be obtained in these regions, each containing 216 A-scans. These images will be registered, and the consecutive B-scans will be used to calculate the decorrelation among the images to provide split-spectrum amplitude decorrelation angiography (SSADA) images. This decorrelation between consecutive B-scan images will be used to highlight locations where there is blood flow. The density of the perfused peripapillary vessels within the various layers of the retina will be calculated to create a flow density map.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Subjects taking B-vitamin supplements

Treatment and study plan

Vitamin B-Complex Supplement

Drug

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

Primary outcomes

  1. Optic Disc Edema

    Time frame: 6 months

    Measure change in total retinal thickness during and after flight compared to preflight using OCT

Secondary outcomes

  1. Endothelial function

    Time frame: 6 months

    Assess reactive hyperemia through changes in fingertip temperature

  2. Advanced Glycation End Products (AGE)

    Time frame: 6 months

    Skin autofluorescence (SAF) will be analyzed non-invasively using an AGE reader

  3. Serum folate status

    Time frame: 6 months

    Vitamin status assessed from a fasting blood sample

  4. Red Blood Cell folate status

    Time frame: 6 months

    Vitamin status assessed from a fasting blood sample

  5. Vitamin B6 status

    Time frame: 6 months

    Vitamin status assessed from a fasting blood sample

  6. Vitamin B12 status

    Time frame: 6 months

    Vitamin status assessed from a fasting blood sample

  7. Glucose

    Time frame: 6 months

    Serum glucose from a fasting blood sample

  8. Nitric oxide

    Time frame: 6 months

    Serum nitric oxide from a fasting blood sample

  9. tetrahydrobiopterin

    Time frame: 6 months

    Serum biochemistry from a fasting blood sample

  10. Dihydrobiopterin

    Time frame: 6 months

    Serum biochemistry from a fasting blood sample

  11. Oxidized glutathione

    Time frame: 6 months

    Serum biochemistry from a fasting blood sample

  12. Total antioxidant capacity

    Time frame: 6 months

    Serum biochemistry from a fasting blood sample

  13. Advanced glycation end products

    Time frame: 6 months

    Serum biochemistry from a fasting blood sample

  14. Albumin

    Time frame: 6 months

    Serum biochemistry from a fasting blood sample

  15. Glycated albumin

    Time frame: 6 months

    Serum biochemistry from a fasting blood sample

  16. 3-nitrotyrosine

    Time frame: 6 months

    Serum biochemistry from a fasting blood sample

  17. Formate

    Time frame: 6 months

    Serum biochemistry from a fasting blood sample

  18. MMP-2

    Time frame: 6 months

    Serum biochemistry from a fasting blood sample

  19. MMP-9

    Time frame: 6 months

    Serum biochemistry from a fasting blood sample

  20. TIMP-1

    Time frame: 6 months

    Serum biochemistry from a fasting blood sample

  21. TIMP-2

    Time frame: 6 months

    Serum biochemistry from a fasting blood sample

  22. Heparan sulfate

    Time frame: 6 months

    Serum biochemistry from a fasting blood sample

  23. Syndecan-1

    Time frame: 6 months

    Serum biochemistry from a fasting blood sample

  24. Glypican

    Time frame: 6 months

    Serum biochemistry from a fasting blood sample

  25. Hyaluronan

    Time frame: 6 months

    Serum biochemistry from a fasting blood sample

  26. Total lipid peroxides

    Time frame: 6 months

    Serum biochemistry from a fasting blood sample

Study contacts

Contact information is provided by the study sponsor or research team.

Eden Fields

CONTACT

[email protected]

2814837864

Sara Zwart, PhD

CONTACT

[email protected]

2814833753

Sponsors and collaborators

Lead sponsor

National Aeronautics and Space Administration (NASA)

Fed

Collaborators

  • Mayo Clinic
  • Texas A&M University

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2032
First posted
May 9, 2022
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.