Effect of Wheat Dextrin on Calcium and Magnesium Absorption

Phase 4

Completed

• Conditions: Colonic Inertia
• Interventions: Dietary Supplement: wheat dextrin; Dietary Supplement: placebo

• Registration Number: NCT01230840
• Lead Sponsor: Creighton University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-06
• Status Verified: 2010-10
• Study Completion: 2010-10
• Study First Submitted: 2010-10-28
• Study First Submitted QC: 2010-10-28
• Last Update Submitted: 2010-10-28
• Study First Posted: 2010-10-29
• Last Update Posted: 2010-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Calcium Absorption	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

Name	Time	Method
Magnesium absorption	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.