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Dietary Intake Modifications to Protect Against Changes in Bone Metabolism

NCT01713634 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2015-11-16

No results posted yet for this study

Summary

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.

Conditions

  • Bone Resorption

Interventions

OTHER

Preflight

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

OTHER

In-flight

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)

Sponsors & Collaborators

  • National Aeronautics and Space Administration (NASA)

    lead FED

Principal Investigators

  • Scott M Smith, PhD · National Aeronautics and Space Administration (NASA)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01713634 on ClinicalTrials.gov