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The Effect of Weight Loss and Dietary Protein Intake on Bone

StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Publications: 8 to 9

    Show what changed: Publications
    Ogilvie AR, Watford M, Wu G, Sukumar D, Kwon J, Shapses SA. Decreased fasting serum glucogenic amino acids with a higher compared to normal protein diet during energy restriction in women: a randomized controlled trial. Amino Acids. 2021 Sep;53(9):1467-1472. doi: 10.1007/s00726-021-03053-0. Epub 202 [...]

    Study Status, Referencesv11

  2. Minor

    Enrollment target: 48 to 60

    Study Status, Study Designv10

  3. Minor

    2 amendments

    2 re-verifications since 2019-03-09, no change to tracked fields

    v8-v9

  4. Minor

    Secondary endpoints: 1 to 2

    Study description expanded, about 5 words

    Show what changed: Secondary endpoints
    Nutrient Adequacy & Diet Quality with normal & higher protein intake
    Show what changed: Study description
    [...] l be reduced on the HP compared to the HC weight loss diet. BoneIn lossa secondary aim, we will beexamine partiallybone explainedmarkers, by changes in fat masshormones and estrogenthe levelsimpact of protein intake on diet quality. Participants will be randomly assigned to one of 2 groups: [...]

    Study Identification, Study Status, Study Description, Outcome Measuresv7

  5. Notable

    Lead sponsor: National Institute on Aging (NIA) to Rutgers University

    Trial status: Recruiting to Completed; Primary and study completion dates changed from estimate of May 2011 to Jun 2010; Site details revised; and 2 more

    Show all 6 changes in this update
    • Notable Lead sponsor: National Institute on Aging (NIA) to Rutgers University
    • Minor Trial status: Recruiting to Completed
    • Minor Primary and study completion dates changed from estimate of May 2011 to Jun 2010
    • Minor Site details revised
    • Minor Collaborator revised
      Show what changed
      RutgersNational UniversityInstitute on Aging (NIA)
    • Minor Publications: 7 to 8
      Show what changed
      Sukumar D, Ambia-Sobhan H, Zurfluh R, Schlussel Y, Stahl TJ, Gordon CL, Shapses SA. Areal and volumetric bone mineral density and geometry at two levels of protein intake during caloric restriction: a randomized, controlled trial. J Bone Miner Res. 2011 Jun;26(6):1339-48. doi: 10.1002/jbmr.318.

    Study Identification, Study Status, Sponsor/Collaborators, Study Design, Contacts/Locations, Referencesv6

Show 4 earlier versions

  1. Minor

    2 amendments

    2 re-verifications since 2009-06-30, no change to tracked fields

    v4-v5

  2. Minor

    Primary completion date: May 2011

    Interventions: Caloric restriction, high protein (Behavioral) to Caloric restriction, high protein (Behavioral), Caloric restriction; normal protein (Behavioral), Counseling (Behavioral); Study arms: 0 to 2

    Study Status, Sponsor/Collaborators, Arms and Interventionsv3

  3. Minor

    Eligibility criteria expanded, about 9 words

    Show what changed: Eligibility criteria
    Inclusion Criteria: Postmenopausal women who are more than 2 years since last menses Obese or overweight Must live in the geographic vicinity of Rutgers University Exclusion Criteria: Currently on any medication known to inf [...]

    Study Status, Eligibilityv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to learn how the amount of protein during moderate weight loss influences bone health. We will also examine how two levels of protein intake affects diet quality.
Trial Details
NCT Number NCT00473031
Lead Sponsor Rutgers University
Collaborators: National Institute on Aging (NIA)
Conditions Weight Loss, Bone Density
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov