NCT02416947

Soluble Corn Fiber Effect on Bone Resorption in Post Menopausal Women

The Effect of Soluble Corn Fiber (SCF) on Bone Resorption in Post-Menopausal Women Using 41Calcium Technology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Purdue University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

This study is designed to study the dose response effect of continuous Soluble Corn Fiber (SCF) intake over a 50 day period on bone resorption in healthy post menopausal women using the 41Calcium methodology. To further understand the dose response effect of SCF bone biomarkers will be studied. Our hypothesis is that soluble corn fiber will reduce bone resorption in a dose dependent manner in comparison to placebo when estimated by urinary 41Calcium excretion as well as bone biomarkers of resorption.

Detailed description

Subjects will be dosed with 41Calcium , a long-lived radio isotope, which will become deposited in the skeleton after about 100 days. During this time subjects will collect 24 h urine monthly to monitor the decrease in 41Calcium urinary excretion. Subsequently, the baseline level of 41Calcium urinary excretion will be evaluated over a 50 day baseline period with 24 h urine collections every 10 days. Participants will then be randomized to one of three doses of soluble corn fiber (0,10,20 g/d) to be consumed in two equivalent doses per day for 50 days. Women will collect 24 h urine every 10 days. Each 50 day period will be followed by a 50 day washout period during which the subjects will continue to collect urine every 10 days.

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	0 g SCF	0 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.
DIETARY_SUPPLEMENT	10g SCF	10 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.
DIETARY_SUPPLEMENT	20g SCF	20 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2015-04-15
• Last updated: 2015-04-15