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OpenTrials
Completed

NCT Number: NCT01713634

Dietary Intake Modifications to Protect Against Changes in Bone Metabolism

Bone loss is not only a well-documented effect of spaceflight on astronauts, but also a condition that affects millions of men and women on Earth each year. Many countermeasures to bone loss have been proposed, and many have been evaluated to some degree. To date, those showing potential have focused on either exercise or pharmacological interventions, but none have targeted dietary intake alone as a factor to predict or minimize bone loss during spaceflight. The investigators proposed to document how the ratio of acid precursors to base precursors in the diet is related to directional changes in markers of bone resorption and formation during flight and recovery from flight. There is a high likelihood for success in predicting the extent of bone loss from dietary intake patterns of astronauts during spaceflight, given that this concept is strongly anchored in data obtained from ground-based experiments in our laboratory and others. The notion of manipulating diet to minimize bone loss could also have significant social and economic impacts for NASA and for the general public - especially given the increasing trends for diets that are high in animal protein and low in fruits and vegetables. The results of the proposed experiments will lead to development of a dietary countermeasure for bone loss consisting of a balanced diet with no associated risks for side effects that might be present with pharmaceuticals or supplements, no requirement for payload mass, and no additional crew time necessary during flight.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johnson Space Center

Houston, Texas, 77058, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Astronauts flying on long-duration (3-6 months) spaceflights

Exclusion criteria

  • Non-astronauts

Treatment and study plan

Preflight

Other

4-d controlled diet sessions will occur twice before flight.

In-flight

Other

4-d controlled diet sessions will take place on flight days 15, 60, 120, and 180. Flight day 30 will only be monitored intakes (subject consume nominal intake)

Primary outcomes

  1. Change in urinary n-telopeptide after 15 days of space flight compared to preflight

    Time frame: 15 days

    24-h NTX will be used as an indicator of bone resorption

  2. Change in urinary n-telopeptide after 30 days of space flight compared to preflight

    Time frame: 30 days

  3. Change in urinary n-telopeptide after 60 days of space flight compared to preflight

    Time frame: 60 days

  4. Change in urinary n-telopeptide after 120 days of space flight compared to preflight

    Time frame: 120 days

  5. Change in urinary n-telopeptide after 180 days of space flight compared to preflight

    Time frame: 180 days

  6. Change in urinary calcium after 15 days of space flight compared to preflight

    Time frame: 15 days

  7. Change in urinary calcium after 60 days of space flight compared to preflight

    Time frame: 60 days

  8. Change in urinary calcium after 120 days of space flight compared to preflight

    Time frame: 120 days

  9. Change in urinary calcium after 180 days of space flight compared to preflight

    Time frame: 180 days

Secondary outcomes

  1. Change in urinary calcium after 30 days of space flight compared to preflight

    Time frame: 30 days

    24-h urinary calcium

Sponsors and collaborators

Lead sponsor

National Aeronautics and Space Administration (NASA)

Fed

Registry information

Official study title

Dietary Intake Can Predict and Protect Against Changes in Bone Metabolism During Spaceflight and Recovery

Acronym: ProK

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Oct 25, 2012
Registry last updated
Nov 16, 2015

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.

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