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Effect of Wheat Dextrin on Calcium and Magnesium Absorption (Benefiber)

Primary Purpose

Colonic Inertia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
wheat dextrin
placebo
Sponsored by
Creighton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Inertia focused on measuring fiber, calcium, magnesium

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

- Subjects will be generally healthy Caucasian females aged 19 and older with no known abnormalities of gastrointestinal function, and taking no medications that might alter absorptive performance. BMI will be between 19 and 31 kg/m2

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    placebo

    wheat dextrin

    Arm Description

    Control cookies will contain no wheat dextrin and will be taken 3 times daily for 2 weeks.

    wheat dextrin (formulated according to the supporter's established method), will be baked in cookies providing three doses per day (≈5 gram of wheat dextrin in each dose)for 2 weeks.

    Outcomes

    Primary Outcome Measures

    Calcium Absorption
    The calcium load to be tested will be 300 mg calcium from calcium and vitamin D fortified TropicanaTM orange juice extrinsically labeled with ≈3-7 μCi of 45Ca. The labeled orange juice will be ingested as part of a light meal, served as breakfast, after an overnight fast.

    Secondary Outcome Measures

    Magnesium absorption
    The magnesium load to be tested will be from calcium and vitamin D fortified TropicanaTM orange juice extrinsically labeled with 30 mg 26Mg. The labeled orange juice will be ingested as part of a light meal, served as breakfast, after an overnight fast.

    Full Information

    First Posted
    October 28, 2010
    Last Updated
    October 28, 2010
    Sponsor
    Creighton University
    Collaborators
    Novartis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01230840
    Brief Title
    Effect of Wheat Dextrin on Calcium and Magnesium Absorption
    Acronym
    Benefiber
    Official Title
    Effect of Wheat Dextrin on Calcium and Magnesium Absorption
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2009 (undefined)
    Primary Completion Date
    June 2010 (Actual)
    Study Completion Date
    October 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Creighton University
    Collaborators
    Novartis

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To compare calcium and magnesium absorption within subjects with and without chronic consumption of wheat dextrin.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colonic Inertia
    Keywords
    fiber, calcium, magnesium

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Control cookies will contain no wheat dextrin and will be taken 3 times daily for 2 weeks.
    Arm Title
    wheat dextrin
    Arm Type
    Experimental
    Arm Description
    wheat dextrin (formulated according to the supporter's established method), will be baked in cookies providing three doses per day (≈5 gram of wheat dextrin in each dose)for 2 weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    wheat dextrin
    Intervention Description
    5 grams of wheat dextrin baked in cookies will be taken 3 times a day for 2 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    placebo
    Intervention Description
    cookies not containing wheat dextrin will be taken 3 times a day for 2 weeks
    Primary Outcome Measure Information:
    Title
    Calcium Absorption
    Description
    The calcium load to be tested will be 300 mg calcium from calcium and vitamin D fortified TropicanaTM orange juice extrinsically labeled with ≈3-7 μCi of 45Ca. The labeled orange juice will be ingested as part of a light meal, served as breakfast, after an overnight fast.
    Time Frame
    within 2-4 weeks
    Secondary Outcome Measure Information:
    Title
    Magnesium absorption
    Description
    The magnesium load to be tested will be from calcium and vitamin D fortified TropicanaTM orange juice extrinsically labeled with 30 mg 26Mg. The labeled orange juice will be ingested as part of a light meal, served as breakfast, after an overnight fast.
    Time Frame
    within 2-4 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - Subjects will be generally healthy Caucasian females aged 19 and older with no known abnormalities of gastrointestinal function, and taking no medications that might alter absorptive performance. BMI will be between 19 and 31 kg/m2 -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Laura Armas, MD
    Organizational Affiliation
    Creighton University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Wheat Dextrin on Calcium and Magnesium Absorption

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