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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02416947
Other study ID # TateLyle Ca41
Secondary ID
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


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
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