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NCT01713634 · ClinicalTrials.gov registry record · NA

Dietary Intake Modifications to Protect Against Changes in Bone Metabolism

A NA study, sponsored by National Aeronautics and Space Administration (NASA).

Completed
Registry status
NA
Development phase
17
Enrollment target

NCT01713634: Completed NA study, sponsored by National Aeronautics and Space Administration (NASA).

NCT01713634 is a NA study that has completed, run by National Aeronautics and Space Administration (NASA). The registered enrollment target is 17 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01713634, a NA study, has completed, sponsored by National Aeronautics and Space Administration (NASA).

COMPLETED
Registry status
NA
Development phase
17 participants
Enrollment target

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.

Primary Outcome

24-h NTX will be used as an indicator of bone resorption

Interventions

  • OTHER Preflight
  • OTHER In-flight

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2009-01
Est. Completion 2015-11
Phase NA

What the finished NCT01713634 record still lists

NCT01713634 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Preflight is the first listed.

NCT01713634 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01713634 about?

NCT01713634 is a clinical study titled "Dietary Intake Modifications to Protect Against Changes in Bone Metabolism". 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 focuse...

What is the current status of trial NCT01713634?

This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2009-01. Estimated completion is 2015-11.

What interventions are being tested in trial NCT01713634?

The interventions under investigation include: Preflight (OTHER), In-flight (OTHER).

Who is sponsoring clinical trial NCT01713634?

This trial is sponsored by National Aeronautics and Space Administration (NASA), which has 8 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01713634's enrollment target sits among peer trials

17 1871st of 2000 higher than 130 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01713634, the US trial registry maintained by the National Library of Medicine. NCT01713634 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.