NCT01660503

Brief Summary

Soluble corn fiber (SCF) has been shown to enhance calcium utilization and bone properties in rats and in adolescent boys and girls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2014

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

1.9 years

First QC Date

August 6, 2012

Last Update Submit

May 2, 2018

Conditions

Osteoporosis

Keywords

Calcium absorptionOsteoporosisBone HealthAdolescent

Outcome Measures

Primary Outcomes (1)

  • Calcium Absorption

    The subject will be asked to consume one snack item in the morning and one snack in the evening for four consecutive weeks. After consuming the SCF product for four weeks the teen will come to Purdue University campus for 3 nights and days (e.g. Thursday noon - Sunday noon). They will reside in university residence hall or hotel near campus. Calcium Absorption testing will be done utilizing 43Ca and 44Ca.

    4 Weeks

Secondary Outcomes (1)

  • GI microbial changes

    4 weeks

Study Arms (3)

No SCF

PLACEBO COMPARATOR

Twice daily consumption of snack foods containing no SCF.

Dietary Supplement: 0 grams SCF

10 grams SCF

EXPERIMENTAL

Twice daily consumption of snack foods, each containing 5 grams SCF

Dietary Supplement: 10 grams SCF

20 grams SCF

EXPERIMENTAL

Twice daily consumption of snack foods, each containing 10 grams SCF

Dietary Supplement: 20 grams SCF

Interventions

0 grams SCFDIETARY_SUPPLEMENT

Given in snack foods (muffins and flavored beverage)

No SCF
10 grams SCFDIETARY_SUPPLEMENT

Given in snack foods (muffins and flavored beverage)

10 grams SCF
20 grams SCFDIETARY_SUPPLEMENT

Given in snack foods (muffins and flavored beverage)

20 grams SCF

Eligibility Criteria

Age9 Years - 13 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy adolescent Caucasian girls between the ages of 12-14. This population has been chosen because they exhibit higher risk for osteoporosis later in life.

You may not qualify if:

  • Habitual dietary patterns including less than 550 and greater than 1500 mg Ca per day. This represents the 5th and 95th percentile of usual intake of girls 9-13 y in the US.
  • History of smoking, alcohol use, illegal or non-prescription drug use
  • History of disordered calcium or bone metabolism e.g. Paget's disease, hyper or hypo-calcemia
  • History of gastrointestinal diseases (Crohn's, celiac, inflammatory bowel disease)
  • History of diseases that affect kidney or liver function.
  • Body Mass Index (BMI) less than 5th percentile for age or greater than the 90th percentile for age
  • Having a broken bone within the last 6 months.
  • Regular consumption of foods or supplements containing prebiotics or probiotics
  • History of pregnancy or use of contraceptives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (1)

  • Whisner CM, Martin BR, Nakatsu CH, Story JA, MacDonald-Clarke CJ, McCabe LD, McCabe GP, Weaver CM. Soluble Corn Fiber Increases Calcium Absorption Associated with Shifts in the Gut Microbiome: A Randomized Dose-Response Trial in Free-Living Pubertal Females. J Nutr. 2016 Jul;146(7):1298-306. doi: 10.3945/jn.115.227256. Epub 2016 Jun 8.

    PMID: 27281813DERIVED

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Connie M Weaver, Ph.D.

    Purdue University

    PRINCIPAL INVESTIGATOR

  • Berdine R Martin, PhD

    Purdue University

    STUDY DIRECTOR

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

August 6, 2012

First Posted

August 8, 2012

Study Start

June 1, 2012

Primary Completion

April 30, 2014

Study Completion

April 30, 2014

Last Updated

May 4, 2018

Record last verified: 2018-05

Locations

US(1)