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Clinical Trials/NCT01230840
NCT01230840CompletedPhase 4

Effect of Wheat Dextrin on Calcium and Magnesium Absorption

Creighton University0 sites40 target enrollmentStarted: October 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
40
Primary Endpoint
Calcium Absorption

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

placebo

Placebo Comparator

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

Intervention: placebo (Dietary Supplement)

wheat dextrin

Experimental

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: wheat dextrin (Dietary Supplement)

Outcomes

Primary Outcomes

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 Outcomes

  • Magnesium absorption(within 2-4 weeks)

Investigators

Sponsor Class
Other

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