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Soluble Corn Fiber Effect on Bone Resorption in Post Menopausal Women

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ClinicalTrials.gov Identifier: NCT02416947
Recruitment Status : Completed
First Posted : April 15, 2015
Last Update Posted : April 15, 2015
Sponsor:
Collaborator:
Tate & Lyle Health & Nutrition Sciences
Information provided by (Responsible Party):
Berdine Martin, Purdue University

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.


Condition or disease Intervention/treatment Phase
Osteoporosis, Postmenopausal Dietary Supplement: 0 g SCF Dietary Supplement: 10g SCF Dietary Supplement: 20g SCF Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Soluble Corn Fiber (SCF) on Bone Resorption in Post-Menopausal Women Using 41Calcium Technology
Study Start Date : March 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 20 g Soluble Corn Fiber




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women at least 4 years Postmenopausal

Exclusion Criteria:

  • Medications affecting bone resorption

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416947


Sponsors and Collaborators
Purdue University
Tate & Lyle Health & Nutrition Sciences
Investigators
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Principal Investigator: Connie M Weaver, Ph.D Purdue University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Berdine Martin, Research Scientist, Nutrition Science, Purdue University
ClinicalTrials.gov Identifier: NCT02416947    
Other Study ID Numbers: TateLyle Ca41
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015
Keywords provided by Berdine Martin, Purdue University:
Soluble Corn Fiber
Osteoporosis
Bone Loss
Additional relevant MeSH terms:
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Osteoporosis
Bone Resorption
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases