NCT01230840

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2010

Completed
Last Updated

October 29, 2010

Status Verified

October 1, 2010

Enrollment Period

8 months

First QC Date

October 28, 2010

Last Update Submit

October 28, 2010

Conditions

Colonic Inertia

Keywords

fibercalciummagnesium

Outcome Measures

Primary Outcomes (1)

  • 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.

    within 2-4 weeks

Secondary Outcomes (1)

  • Magnesium absorption

    within 2-4 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

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

Dietary Supplement: placebo

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.

Dietary Supplement: wheat dextrin

Interventions

wheat dextrinDIETARY_SUPPLEMENT

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

wheat dextrin
placeboDIETARY_SUPPLEMENT

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

placebo

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Laura Armas, MD

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 28, 2010

First Posted

October 29, 2010

Study Start

October 1, 2009

Primary Completion

June 1, 2010

Study Completion

October 1, 2010

Last Updated

October 29, 2010

Record last verified: 2010-10