- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01713634
Dietary Intake Modifications to Protect Against Changes in Bone Metabolism (ProK)
November 13, 2015 updated by: Scott M. Smith, National Aeronautics and Space Administration (NASA)
Dietary Intake Can Predict and Protect Against Changes in Bone Metabolism During Spaceflight and Recovery
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Houston, Texas, United States, 77058
- Johnson Space Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Astronauts flying on long-duration (3-6 months) spaceflights
Exclusion Criteria:
- Non-astronauts
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
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4-d controlled diet sessions will occur twice before 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)
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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.
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4-d controlled diet sessions will occur twice before 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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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15 days
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Change in urinary n-telopeptide after 30 days of space flight compared to preflight
Time Frame: 30 days
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30 days
|
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Change in urinary n-telopeptide after 60 days of space flight compared to preflight
Time Frame: 60 days
|
60 days
|
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Change in urinary n-telopeptide after 120 days of space flight compared to preflight
Time Frame: 120 days
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120 days
|
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Change in urinary n-telopeptide after 180 days of space flight compared to preflight
Time Frame: 180 days
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180 days
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Change in urinary calcium after 15 days of space flight compared to preflight
Time Frame: 15 days
|
15 days
|
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Change in urinary calcium after 60 days of space flight compared to preflight
Time Frame: 60 days
|
60 days
|
|
Change in urinary calcium after 120 days of space flight compared to preflight
Time Frame: 120 days
|
120 days
|
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Change in urinary calcium after 180 days of space flight compared to preflight
Time Frame: 180 days
|
180 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in urinary calcium after 30 days of space flight compared to preflight
Time Frame: 30 days
|
24-h urinary calcium
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30 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1093/ajcn/80.4.1058.
- 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. doi: 10.1152/japplphysiol.01406.2004. Epub 2005 Feb 3. Erratum In: J Appl Physiol (1985). 2013 Sep;115(6):950.
- Zwart SR, Rice BL, Dlouhy H, Shackelford LC, Heer M, Koslovsky MD, Smith SM. Dietary acid load and bone turnover during long-duration spaceflight and bed rest. Am J Clin Nutr. 2018 May 1;107(5):834-844. doi: 10.1093/ajcn/nqy029.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (ACTUAL)
November 1, 2015
Study Completion (ACTUAL)
November 1, 2015
Study Registration Dates
First Submitted
October 19, 2012
First Submitted That Met QC Criteria
October 24, 2012
First Posted (ESTIMATE)
October 25, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
November 16, 2015
Last Update Submitted That Met QC Criteria
November 13, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro0225
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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