Dietary Intake Modifications to Protect Against Changes in Bone Metabolism (ProK)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Bone Resorption |
Other: Preflight Other: In-flight |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Dietary Intake Can Predict and Protect Against Changes in Bone Metabolism During Spaceflight and Recovery |
- Change in urinary n-telopeptide after 15 days of space flight compared to preflight [ Time Frame: 15 days ] [ Designated as safety issue: No ]24-h NTX will be used as an indicator of bone resorption
- Change in urinary n-telopeptide after 30 days of space flight compared to preflight [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Change in urinary n-telopeptide after 60 days of space flight compared to preflight [ Time Frame: 60 days ] [ Designated as safety issue: No ]
- Change in urinary n-telopeptide after 120 days of space flight compared to preflight [ Time Frame: 120 days ] [ Designated as safety issue: No ]
- Change in urinary n-telopeptide after 180 days of space flight compared to preflight [ Time Frame: 180 days ] [ Designated as safety issue: No ]
- Change in urinary calcium after 15 days of space flight compared to preflight [ Time Frame: 15 days ] [ Designated as safety issue: No ]
- Change in urinary calcium after 60 days of space flight compared to preflight [ Time Frame: 60 days ] [ Designated as safety issue: No ]
- Change in urinary calcium after 120 days of space flight compared to preflight [ Time Frame: 120 days ] [ Designated as safety issue: No ]
- Change in urinary calcium after 180 days of space flight compared to preflight [ Time Frame: 180 days ] [ Designated as safety issue: No ]
- Change in urinary calcium after 30 days of space flight compared to preflight [ Time Frame: 30 days ] [ Designated as safety issue: No ]24-h urinary calcium
| Estimated Enrollment: | 16 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Low Apro/K Diet
Subjects consume a prescribed diet for 4 days with a low ratio of animal protein to potassium (0.3-0.6 g/mEq).
|
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)
|
|
Experimental: High Apro/K Diet
Subjects consume a prescribed diet that has a high ratio of animal protein to potassium (1.0-1.3 g/mEq) for 4 days.
|
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)
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Astronauts flying on long-duration (3-6 months) spaceflights
Exclusion Criteria:
- Non-astronauts
Contacts and Locations| United States, Texas | |
| Johnson Space Center | |
| Houston, Texas, United States, 77058 | |
| Principal Investigator: | Scott M Smith, PhD | National Aeronautics and Space Administration (NASA) |
More Information
Additional Information:
Publications:
| Responsible Party: | Scott M. Smith, Manager for Nutritional Biochemistry, National Aeronautics and Space Administration (NASA) |
| ClinicalTrials.gov Identifier: | NCT01713634 History of Changes |
| Other Study ID Numbers: | Pro0225 |
| Study First Received: | October 19, 2012 |
| Last Updated: | March 22, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by National Aeronautics and Space Administration (NASA):
|
Bone resorption Diet |
Additional relevant MeSH terms:
|
Bone Resorption Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013