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

October 28, 2010 updated by: Creighton University
To compare calcium and magnesium absorption within subjects with and without chronic consumption of wheat dextrin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 2-4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 2-4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Collaborators

Novartis

Investigators

  • Principal Investigator: Laura Armas, MD, Creighton University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

October 28, 2010

First Submitted That Met QC Criteria

October 28, 2010

First Posted (Estimate)

October 29, 2010

Study Record Updates

Last Update Posted (Estimate)

October 29, 2010

Last Update Submitted That Met QC Criteria

October 28, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-15249

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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