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Effect of Wheat Dextrin on Calcium and Magnesium Absorption

NCT ID: NCT01230840

Last Updated: 2010-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-10-31

Brief Summary

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

Detailed Description

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Conditions

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Colonic Inertia

Keywords

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fiber calcium magnesium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

cookies not containing wheat dextrin will be taken 3 times a day for 2 weeks

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.

Group Type EXPERIMENTAL

wheat dextrin

Intervention Type DIETARY_SUPPLEMENT

5 grams of wheat dextrin baked in cookies will be taken 3 times a day for 2 weeks

Interventions

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wheat dextrin

5 grams of wheat dextrin baked in cookies will be taken 3 times a day for 2 weeks

Intervention Type DIETARY_SUPPLEMENT

placebo

cookies not containing wheat dextrin will be taken 3 times a day for 2 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

\-
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Creighton University

Principal Investigators

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Laura Armas, MD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Other Identifiers

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09-15249

Identifier Type: -

Identifier Source: org_study_id