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Caloric Restriction and Body Weight in Adults

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dietary calcium
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring dietary calcium, weight loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 -65 years old
  • Healthy

Exclusion Criteria:

  • Body weight more than 300 lbs (body composition measurement instrument limit) diabetes
  • Heart disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Dairy calcium

    Non-dairy calcium

    Arm Description

    Diet with dairy calcium sources

    Diet with non-dairy calcium sources

    Outcomes

    Primary Outcome Measures

    Fat in stool as a percentage of fat intake

    Secondary Outcome Measures

    Weight change

    Full Information

    First Posted
    December 12, 2008
    Last Updated
    December 2, 2011
    Sponsor
    Vanderbilt University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00808275
    Brief Title
    Caloric Restriction and Body Weight in Adults
    Official Title
    Effect of Dietary Calcium on Body Weight Regulation in Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2004 (undefined)
    Primary Completion Date
    September 2006 (Actual)
    Study Completion Date
    October 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vanderbilt University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the role of dietary calcium in fecal fat loss and the association between lactose maldigestion, dietary calcium level and source, and weight loss induced by caloric restriction. caloric restriction on biomarkers of inflammation and oxidative stress

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight
    Keywords
    dietary calcium, weight loss

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    79 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dairy calcium
    Arm Type
    Experimental
    Arm Description
    Diet with dairy calcium sources
    Arm Title
    Non-dairy calcium
    Arm Type
    Experimental
    Arm Description
    Diet with non-dairy calcium sources
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Dietary calcium
    Intervention Description
    Dairy and non-dairy calcium provided as a part of diet in the amounts of 500 mg/day and 1500 mg/day. Diet contained 70% of daily caloric requirements.
    Primary Outcome Measure Information:
    Title
    Fat in stool as a percentage of fat intake
    Time Frame
    3 months of diet
    Secondary Outcome Measure Information:
    Title
    Weight change
    Time Frame
    3 months of diet

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18 -65 years old Healthy Exclusion Criteria: Body weight more than 300 lbs (body composition measurement instrument limit) diabetes Heart disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maciej Buchowski, Ph.D.
    Organizational Affiliation
    Vanderbilt University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23071718
    Citation
    Buchowski MS, Hongu N, Acra S, Wang L, Warolin J, Roberts LJ 2nd. Effect of modest caloric restriction on oxidative stress in women, a randomized trial. PLoS One. 2012;7(10):e47079. doi: 10.1371/journal.pone.0047079. Epub 2012 Oct 5.
    Results Reference
    derived
    PubMed Identifier
    19823185
    Citation
    Buchowski MS, Aslam M, Dossett C, Dorminy C, Choi L, Acra S. Effect of dairy and non-dairy calcium on fecal fat excretion in lactose digester and maldigester obese adults. Int J Obes (Lond). 2010 Jan;34(1):127-35. doi: 10.1038/ijo.2009.212. Epub 2009 Oct 13.
    Results Reference
    derived

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    Caloric Restriction and Body Weight in Adults

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