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

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ClinicalTrials.gov Identifier: NCT01230840
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : October 29, 2010
Sponsor:
Collaborator:
Novartis
Information provided by:
Creighton University

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

Condition or disease Intervention/treatment Phase
Colonic Inertia Dietary Supplement: wheat dextrin Dietary Supplement: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Wheat Dextrin on Calcium and Magnesium Absorption
Study Start Date : October 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Placebo Comparator: placebo
Control cookies will contain no wheat dextrin and will be taken 3 times daily for 2 weeks.
Dietary Supplement: placebo
cookies not containing wheat dextrin will be taken 3 times a day for 2 weeks

Experimental: wheat dextrin
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.
Dietary Supplement: wheat dextrin
5 grams of wheat dextrin baked in cookies will be taken 3 times a day for 2 weeks




Primary Outcome Measures :
  1. Calcium Absorption [ Time Frame: within 2-4 weeks ]
    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 :
  1. Magnesium absorption [ Time Frame: within 2-4 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230840


Sponsors and Collaborators
Creighton University
Novartis
Investigators
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Principal Investigator: Laura Armas, MD Creighton University
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Responsible Party: Laura Armas MD, Creighton University
ClinicalTrials.gov Identifier: NCT01230840    
Other Study ID Numbers: 09-15249
First Posted: October 29, 2010    Key Record Dates
Last Update Posted: October 29, 2010
Last Verified: October 2010
Keywords provided by Creighton University:
fiber
calcium
magnesium
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms