Soluble Corn Fiber Effect on Bone Resorption in Post Menopausal Women

Not Applicable

Completed

• Conditions: Osteoporosis, Postmenopausal
• Interventions: Dietary Supplement: 20g SCF; Dietary Supplement: 0 g SCF; Dietary Supplement: 10g SCF

• Registration Number: NCT02416947
• Lead Sponsor: Purdue University

Brief 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.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-04
• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-04-14
• Last Update Submitted: 2015-04-14
• Study First Posted: 2015-04-15
• Last Update Posted: 2015-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

Inclusion Criteria

• Women at least 4 years Postmenopausal

Exclusion Criteria

• Medications affecting bone resorption

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
20g SCF	20g SCF	Subjects will consume 20 g of SCF in two equal doses as a muffin and a drink, daily for 50 days.
0g SCF	0 g SCF	Subjects will consume 0 g of SCF in two equal doses as a muffin and a drink, daily for 50 days.
10 g SCF	10g SCF	Subjects will consume 10 g of SCF in two equal doses as a muffin and a drink, daily for 50 days.

Primary Outcome Measures

Name	Time	Method
Change in 41Ca/Ca ratio in five 24 h urine collections during intervention periods compared to urinary 41Ca/Ca ratios during non-intervention periods	24 h urine collections on days 10, 20, 30, 40, and 50 of each of three intervention periods and 4 non intervention periods	41Ca/Ca ratio will be determined by Accelerator Mass Spectrometry. A linear regression model including the data from the non-intervention ratios will determine the predicted 41Ca/Ca ratios over the course of the 350 day study. The percent change of 41Ca/Ca ratios in the 50 day intervention periods from the predicted values will determine the effect of the intervention.

Secondary Outcome Measures

Name	Time	Method
Fasting serum bone specific alkaline phosphatase (BSAP), a biochemical bone formation marker	Fasting serum drawn at the end of each 50 day intervention period
Fasting urine N-terminal telopeptide, a biochemical bone resorption marker	Fasting urine collected at the end of each 50 day intervention period
Fasting serum osteocalcin (OC), a biochemical bone turnover marker	Fasting serum drawn at the end of each 50 day intervention period