Dietary Intake Modifications to Protect Against Changes in Bone Metabolism

Bone Resorption Clinical Trial

— ProK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01713634
• Other study ID #: Pro0225
• Status: Completed
• Phase: N/A
• First received: October 19, 2012
• Last updated: November 13, 2015
• Start date: January 2009
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: National Aeronautics and Space Administration (NASA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Non-astronauts

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bone Resorption

Intervention

Other:
• Preflight
4-d controlled diet sessions will occur twice before flight.
• 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)

Locations

Country	Name	City	State
United States	Johnson Space Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Aeronautics and Space Administration (NASA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Zwart SR, Davis-Street JE, Paddon-Jones D, Ferrando AA, Wolfe RR, Smith SM. Amino acid supplementation alters bone metabolism during simulated weightlessness. J Appl Physiol (1985). 2005 Jul;99(1):134-40. Epub 2005 Feb 3. Erratum in: J Appl Physiol (1985). 2013 Sep;115(6):950. — View Citation

Zwart SR, Hargens AR, Smith SM. The ratio of animal protein intake to potassium intake is a predictor of bone resorption in space flight analogues and in ambulatory subjects. Am J Clin Nutr. 2004 Oct;80(4):1058-65. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in urinary n-telopeptide after 15 days of space flight compared to preflight	24-h NTX will be used as an indicator of bone resorption	15 days	No
Primary	Change in urinary n-telopeptide after 30 days of space flight compared to preflight		30 days	No
Primary	Change in urinary n-telopeptide after 60 days of space flight compared to preflight		60 days	No
Primary	Change in urinary n-telopeptide after 120 days of space flight compared to preflight		120 days	No
Primary	Change in urinary n-telopeptide after 180 days of space flight compared to preflight		180 days	No
Primary	Change in urinary calcium after 15 days of space flight compared to preflight		15 days	No
Primary	Change in urinary calcium after 60 days of space flight compared to preflight		60 days	No
Primary	Change in urinary calcium after 120 days of space flight compared to preflight		120 days	No
Primary	Change in urinary calcium after 180 days of space flight compared to preflight		180 days	No
Secondary	Change in urinary calcium after 30 days of space flight compared to preflight	24-h urinary calcium	30 days	No

External Links

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