NCT02416947

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

2.8 years

First QC Date

April 8, 2015

Last Update Submit

April 14, 2015

Conditions

Osteoporosis, Postmenopausal

Keywords

Soluble Corn FiberOsteoporosisBone Loss

Outcome Measures

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

    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 Outcomes (3)

  • 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

Study Arms (3)

0g SCF

PLACEBO COMPARATOR

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

10 g SCF

ACTIVE COMPARATOR

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

20g SCF

ACTIVE COMPARATOR

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

Interventions

0 g SCFDIETARY_SUPPLEMENT

0 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.

Also known as: 0 g Soluble Corn Fiber
0g SCF
10g SCFDIETARY_SUPPLEMENT

10 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.

Also known as: 10 g Soluble Corn Fiber
10 g SCF
20g SCFDIETARY_SUPPLEMENT

20 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.

Also known as: 20 g Soluble Corn Fiber
20g SCF

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women at least 4 years Postmenopausal

You may not qualify if:

  • Medications affecting bone resorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27465372DERIVED

MeSH Terms

Conditions

Osteoporosis, PostmenopausalOsteoporosisBone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Connie M Weaver, Ph.D

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist, Nutrition Science

Study Record Dates

First Submitted

April 8, 2015

First Posted

April 15, 2015

Study Start

March 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

April 15, 2015

Record last verified: 2015-04