Soluble Corn Fiber Effect on Bone Resorption in Post Menopausal Women

April 14, 2015 updated by: Berdine Martin, Purdue University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women at least 4 years Postmenopausal

Exclusion Criteria:

  • Medications affecting bone resorption

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 0g SCF
Subjects will consume 0 g of SCF in two equal doses as a muffin and a drink, daily for 50 days.
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.
Other Names:
  • 0 g Soluble Corn Fiber
Active Comparator: 10 g SCF
Subjects will consume 10 g of SCF in two equal doses as a muffin and a drink, daily for 50 days.
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.
Other Names:
  • 10 g Soluble Corn Fiber
Active Comparator: 20g SCF
Subjects will consume 20 g of SCF in two equal doses as a muffin and a drink, daily for 50 days.
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.
Other Names:
  • 20 g Soluble Corn Fiber

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 41Ca/Ca ratio in five 24 h urine collections during intervention periods compared to urinary 41Ca/Ca ratios during non-intervention periods
Time Frame: 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.
24 h urine collections on days 10, 20, 30, 40, and 50 of each of three intervention periods and 4 non intervention periods

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Collaborators

Tate & Lyle Health & Nutrition Sciences

Investigators

  • Principal Investigator: Connie M Weaver, Ph.D, Purdue University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

April 8, 2015

First Submitted That Met QC Criteria

April 14, 2015

First Posted (Estimate)

April 15, 2015

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TateLyle Ca41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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