Dietary Intake Modifications to Protect Against Changes in Bone Metabolism

NCT01713634 | Completed

• 1 other identifier: Pro0225
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bone Resorption

Keywords

Bone resorption; Diet

Outcome Measures

Primary Outcomes (9)

• 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

• Change in urinary n-telopeptide after 30 days of space flight compared to preflight

  30 days

• Change in urinary n-telopeptide after 60 days of space flight compared to preflight

  60 days

• Change in urinary n-telopeptide after 120 days of space flight compared to preflight

  120 days

• Change in urinary n-telopeptide after 180 days of space flight compared to preflight

  180 days

• Change in urinary calcium after 15 days of space flight compared to preflight

  15 days

• Change in urinary calcium after 60 days of space flight compared to preflight

  60 days

• Change in urinary calcium after 120 days of space flight compared to preflight

  120 days

• Change in urinary calcium after 180 days of space flight compared to preflight

  180 days

Secondary Outcomes (1)

• Change in urinary calcium after 30 days of space flight compared to preflight

  30 days

Study Arms (2)

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).

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.

Other: Preflight; Other: In-flight

Interventions

Preflight OTHER

4-d controlled diet sessions will occur twice before flight.

High Apro/K Diet; Low Apro/K Diet

In-flight OTHER

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)

High Apro/K Diet; Low Apro/K Diet

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Non-astronauts

Sponsors & Collaborators

• National Aeronautics and Space Administration (NASA): lead

Study Sites (1)

Johnson Space Center

Houston, Texas, 77058, United States

Location

Related Publications (3)

• 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.

  PMID: 15447920 BACKGROUND

• 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.

  PMID: 15691900 BACKGROUND

• 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.

  PMID: 29722847 DERIVED

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• Scott M Smith, PhD

  National Aeronautics and Space Administration (NASA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager for Nutritional Biochemistry

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: October 25, 2012
• Study Start: January 1, 2009
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 16, 2015

Record last verified: 2015-11

Locations

US (1)