Soluble Corn Fiber Effect on Bone Resorption in Post Menopausal Women

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoporosis, Postmenopausal

Intervention / Treatment
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* Dietary Supplement: 0 g SCF
* Dietary Supplement: 10g SCF
* Dietary Supplement: 20g SCF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women at least 4 years Postmenopausal Exclusion Criteria: Medications affecting bone resorption
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 0g SCF<br>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<br>* 0 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.<br>* Other names: 0 g Soluble Corn Fiber;|
| Active Comparator: 10 g SCF<br>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<br>* 10 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.<br>* Other names: 10 g Soluble Corn Fiber;|
| Active Comparator: 20g SCF<br>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<br>* 20 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.<br>* Other names: 20 g Soluble Corn Fiber;|

What is the study measuring?
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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 | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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 serum osteocalcin (OC), a biochemical bone turnover 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Soluble Corn Fiber, Osteoporosis, Bone Loss