Bone ResorptionProKNCT01713634
Dietary Intake Modifications to Protect Against Changes in Bone Metabolism
A study testing Preflight and In-flight in people with Bone Resorption, run by National Aeronautics and Space Administration (NASA) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption
- What is being tested?
- Preflight and In-flight
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Astronauts flying on long-duration (3-6 months) spaceflights
Who cannot join
- Non-astronauts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Bone Resorption
- Being tested
- Preflight, In-flight
- Keywords
- Bone resorption, Diet
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreflightOther
4-d controlled diet sessions will occur twice before flight.
In-flightOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Low Apro/K Diet | Experimental | Subjects consume a prescribed diet for 4 days with a low ratio of animal protein to potassium (0.3-0.6 g/mEq). Receives: Other: Preflight; Other: In-flight |
| High Apro/K Diet | Experimental | Subjects consume a prescribed diet that has a high ratio of animal protein to potassium (1.0-1.3 g/mEq) for 4 days. Receives: Other: Preflight; Other: In-flight |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 days
Change in urinary n-telopeptide after 30 days of space flight compared to preflight
Measured: 30 days
Change in urinary n-telopeptide after 60 days of space flight compared to preflight
Measured: 60 days
Change in urinary n-telopeptide after 120 days of space flight compared to preflight
Measured: 120 days
Change in urinary n-telopeptide after 180 days of space flight compared to preflight
Measured: 180 days
Change in urinary calcium after 15 days of space flight compared to preflight
Measured: 15 days
Change in urinary calcium after 60 days of space flight compared to preflight
Measured: 60 days
Change in urinary calcium after 120 days of space flight compared to preflight
Measured: 120 days
Change in urinary calcium after 180 days of space flight compared to preflight
Measured: 180 days
Secondary outcomes (1)
Change in urinary calcium after 30 days of space flight compared to preflight
24-h urinary calcium
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startJan 2009
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bone ResorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Aeronautics and Space Administration (NASA)
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Scott M. Smith, National Aeronautics and Space Administration (NASA)
- Investigators
- Scott M Smith, PhD, Principal investigator, National Aeronautics and Space Administration (NASA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713634
- Sponsor's protocol ID
- Pro0225
- Acronym
- ProK
- Status last verified
- Nov 2015
- First submitted
- 19 Oct 2012
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Zwart SR, Hargens AR, Smith SM; New Collective Author. 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.
PubMed 15447920Zwart SR, Davis-Street JE, Paddon-Jones D, Ferrando AA, Wolfe RR, Smith SM; New Collective Author. 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.
PubMed 15691900Zwart 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.
PubMed 29722847
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intake Can Predict and Protect Against Changes in Bone Metabolism During Spaceflight and Recovery
- ClinicalTrials.gov ID
- NCT01713634
- Acronym / sponsor ID
- ProK / Pro0225
- Conditions
- Bone Resorption
- Keywords
- Bone resorption, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- National Aeronautics and Space Administration (NASA)US federal agency
- Study start
- Jan 2009
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Apro/K Diet | Experimental | Other: Preflight, Other: In-flightSubjects consume a prescribed diet for 4 days with a low ratio of animal protein to potassium (0.3-0.6 g/mEq). |
| High Apro/K Diet | Experimental | Other: Preflight, Other: In-flightSubjects consume a prescribed diet that has a high ratio of animal protein to potassium (1.0-1.3 g/mEq) for 4 days. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Astronauts flying on long-duration (3-6 months) spaceflights
Key exclusion criteria (1 listed)
- Non-astronauts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preflight4-d controlled diet sessions will occur twice before flight. | Other | High Apro/K Diet, Low Apro/K Diet |
| In-flight4-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) | Other | High Apro/K Diet, Low Apro/K Diet |
Primary outcome
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
Change in urinary n-telopeptide after 30 days of space flight compared to preflight
Time frame: 30 days
Change in urinary n-telopeptide after 60 days of space flight compared to preflight
Time frame: 60 days
Change in urinary n-telopeptide after 120 days of space flight compared to preflight
Time frame: 120 days
Change in urinary n-telopeptide after 180 days of space flight compared to preflight
Time frame: 180 days
Change in urinary calcium after 15 days of space flight compared to preflight
Time frame: 15 days
Change in urinary calcium after 60 days of space flight compared to preflight
Time frame: 60 days
Change in urinary calcium after 120 days of space flight compared to preflight
Time frame: 120 days
Change in urinary calcium after 180 days of space flight compared to preflight
Time frame: 180 days
1 secondary outcome
Change in urinary calcium after 30 days of space flight compared to preflight
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
- Background: PubMed 15447920Zwart SR, Hargens AR, Smith SM; New Collective Author. 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.
- Background: PubMed 15691900Zwart SR, Davis-Street JE, Paddon-Jones D, Ferrando AA, Wolfe RR, Smith SM; New Collective Author. 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.
- Derived from this study: PubMed 29722847Zwart 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott M Smith, PhD principal investigator
National Aeronautics and Space Administration (NASA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preflight and In-flight in people with Bone Resorption, run by National Aeronautics and Space Administration (NASA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urinary n-telopeptide after 15 days of space flight compared to preflight (time frame: 15 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01713634, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2015; AzTrials last refreshed its copy on 1 Nov 2026.