Skip to main content
OpenTrials
Completed

NCT Number: NCT02416947

Soluble Corn Fiber Effect on Bone Resorption in Post Menopausal Women

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoporosis, Postmenopausal Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women at least 4 years Postmenopausal

Exclusion criteria

  • Medications affecting bone resorption

Treatment and study plan

0 g SCF

Dietary Supplement

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

10g SCF

Dietary Supplement

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

20g SCF

Dietary Supplement

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Fasting serum osteocalcin (OC), a biochemical bone turnover marker

    Time frame: Fasting serum drawn at the end of each 50 day intervention period

  3. Fasting urine N-terminal telopeptide, a biochemical bone resorption marker

    Time frame: Fasting urine collected at the end of each 50 day intervention period

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • Tate & Lyle Health & Nutrition Sciences

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 15, 2015
Registry last updated
Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.