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Soluble Corn Fiber Effect on Bone Resorption in Post Menopausal Women

Primary Purpose

Osteoporosis, Postmenopausal

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
0 g SCF
10g SCF
20g SCF
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis, Postmenopausal focused on measuring Soluble Corn Fiber, Osteoporosis, Bone Loss

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women at least 4 years Postmenopausal

Exclusion Criteria:

  • Medications affecting bone resorption

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    0g SCF

    10 g SCF

    20g SCF

    Arm Description

    Subjects will consume 0 g of SCF in two equal doses as a muffin and a drink, daily for 50 days.

    Subjects will consume 10 g of SCF in two equal doses as a muffin and a drink, daily for 50 days.

    Subjects will consume 20 g of SCF in two equal doses as a muffin and a drink, daily for 50 days.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Fasting serum bone specific alkaline phosphatase (BSAP), a biochemical bone formation marker
    Fasting serum osteocalcin (OC), a biochemical bone turnover marker
    Fasting urine N-terminal telopeptide, a biochemical bone resorption marker

    Full Information

    First Posted
    April 8, 2015
    Last Updated
    April 14, 2015
    Sponsor
    Purdue University
    Collaborators
    Tate & Lyle Health & Nutrition Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02416947
    Brief Title
    Soluble Corn Fiber Effect on Bone Resorption in Post Menopausal Women
    Official Title
    The Effect of Soluble Corn Fiber (SCF) on Bone Resorption in Post-Menopausal Women Using 41Calcium Technology
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2012 (undefined)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Purdue University
    Collaborators
    Tate & Lyle Health & Nutrition Sciences

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis, Postmenopausal
    Keywords
    Soluble Corn Fiber, Osteoporosis, Bone Loss

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    0g SCF
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects will consume 0 g of SCF in two equal doses as a muffin and a drink, daily for 50 days.
    Arm Title
    10 g SCF
    Arm Type
    Active Comparator
    Arm Description
    Subjects will consume 10 g of SCF in two equal doses as a muffin and a drink, daily for 50 days.
    Arm Title
    20g SCF
    Arm Type
    Active Comparator
    Arm Description
    Subjects will consume 20 g of SCF in two equal doses as a muffin and a drink, daily for 50 days.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    0 g SCF
    Other Intervention Name(s)
    0 g Soluble Corn Fiber
    Intervention Description
    0 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    10g SCF
    Other Intervention Name(s)
    10 g Soluble Corn Fiber
    Intervention Description
    10 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    20g SCF
    Other Intervention Name(s)
    20 g Soluble Corn Fiber
    Intervention Description
    20 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.
    Primary Outcome Measure Information:
    Title
    Change in 41Ca/Ca ratio in five 24 h urine collections during intervention periods compared to urinary 41Ca/Ca ratios during non-intervention periods
    Description
    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.
    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
    Secondary Outcome Measure Information:
    Title
    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
    Title
    Fasting serum osteocalcin (OC), a biochemical bone turnover marker
    Time Frame
    Fasting serum drawn at the end of each 50 day intervention period
    Title
    Fasting urine N-terminal telopeptide, a biochemical bone resorption marker
    Time Frame
    Fasting urine collected at the end of each 50 day intervention period

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Women at least 4 years Postmenopausal Exclusion Criteria: Medications affecting bone resorption
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Connie M Weaver, Ph.D
    Organizational Affiliation
    Purdue University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27465372
    Citation
    Jakeman SA, Henry CN, Martin BR, McCabe GP, McCabe LD, Jackson GS, Peacock M, Weaver CM. Soluble corn fiber increases bone calcium retention in postmenopausal women in a dose-dependent manner: a randomized crossover trial. Am J Clin Nutr. 2016 Sep;104(3):837-43. doi: 10.3945/ajcn.116.132761. Epub 2016 Jul 27. Erratum In: Am J Clin Nutr. 2017 Mar;105(3):772.
    Results Reference
    derived

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    Soluble Corn Fiber Effect on Bone Resorption in Post Menopausal Women

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