Effect of Wheat Dextrin on Calcium and Magnesium Absorption

Colonic Inertia Clinical Trial

— Benefiber  

Official title:

Effect of Wheat Dextrin on Calcium and Magnesium Absorption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01230840
• Other study ID #: 09-15249
• Status: Completed
• Phase: Phase 4
• First received: October 28, 2010
• Last updated: October 28, 2010
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: October 2010
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Inertia

Intervention

Dietary Supplement:
• wheat dextrin
5 grams of wheat dextrin baked in cookies will be taken 3 times a day for 2 weeks
• placebo
cookies not containing wheat dextrin will be taken 3 times a day for 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Creighton University	Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Magnesium absorption	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	No