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
About this trial
This is an interventional prevention trial for Osteoporosis, Postmenopausal focused on measuring Soluble Corn Fiber, Osteoporosis, Bone Loss
Eligibility Criteria
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
NCT ID
NCT02416947
First Posted
April 8, 2015
Last Updated
April 14, 2015
Sponsor
Purdue University
Collaborators
Tate & Lyle Health & Nutrition Sciences
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
Learn more about this trial
Soluble Corn Fiber Effect on Bone Resorption in Post Menopausal Women
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