Soluble Corn Fiber Effect on Bone Resorption in Post Menopausal Women

Osteoporosis, Postmenopausal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02416947
• Other study ID #: TateLyle Ca41
• Status: Completed
• Phase: N/A
• First received: April 8, 2015
• Last updated: April 14, 2015
• Start date: March 2012
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Women at least 4 years Postmenopausal

Exclusion Criteria:

• Medications affecting bone resorption

Study Design

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

Related Conditions & MeSH terms

• Bone Resorption
• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

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.
• 10g SCF
10 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.
• 20g SCF
20 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	Tate & Lyle Health & Nutrition Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 41Ca/Ca ratio in five 24 h urine collections during intervention periods compared to urinary 41Ca/Ca ratios during 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.	24 h urine collections on days 10, 20, 30, 40, and 50 of each of three intervention periods and 4 non intervention periods	No
Secondary	Fasting serum bone specific alkaline phosphatase (BSAP), a biochemical bone formation marker		Fasting serum drawn at the end of each 50 day intervention period	No
Secondary	Fasting serum osteocalcin (OC), a biochemical bone turnover marker		Fasting serum drawn at the end of each 50 day intervention period	No
Secondary	Fasting urine N-terminal telopeptide, a biochemical bone resorption marker		Fasting urine collected at the end of each 50 day intervention period	No