NCT01571440

Brief Summary

The purpose of this study was to determine the effect of soluble corn fiber on calcium absorption and retention and gut microflora in adolescent boys and girls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Shorter than P25 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

February 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2011

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
Last Updated

February 10, 2014

Status Verified

February 1, 2014

Enrollment Period

5 months

First QC Date

January 12, 2011

Last Update Submit

February 7, 2014

Conditions

Osteoporosis

Keywords

Boneadolescentsfiberhealthyboysgirlscampcalcium

Outcome Measures

Primary Outcomes (2)

  • Calcium absorption and retention

    up to three weeks

  • Gut microbial profile

    up to three weeks

Secondary Outcomes (1)

  • Bone mineral content and density

    up to three weeks

Study Arms (2)

No Soluble Corn Fiber

PLACEBO COMPARATOR

Each teen will receive a package of fruit snacks containing 0 g soluble corn fiber two times daily.

Dietary Supplement: No soluble corn fiber

12 g Soluble Corn Fiber

ACTIVE COMPARATOR

Each teen will receive a package of fruit snacks containing 6 g soluble corn fiber two times daily

Dietary Supplement: 12 g soluble corn fiber

Interventions

No soluble corn fiberDIETARY_SUPPLEMENT

Each teen will receive a package of fruit snacks containing 0 g soluble corn fiber two times per day

Also known as: soluble corn fiber
No Soluble Corn Fiber
12 g soluble corn fiberDIETARY_SUPPLEMENT

Each teen will receive a package of fruit snacks containing 6 g soluble corn fiber two times per day.

Also known as: soluble corn fiber
12 g Soluble Corn Fiber

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Normal, healthy, white adolescents (Hispanic or non-Hispanic)
  • Boys age 13-15
  • Girls age 12-14

You may not qualify if:

  • Abnormal kidney or liver function
  • Malabsorptive disorders
  • Anemia
  • Smoking
  • History of medications that affect calcium metabolism
  • Body weight outside 5-95 percentile body mass index (BMI) for age
  • Regular consumption of illegal drugs
  • Contraceptive use
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

OsteoporosisMuscle Cramp

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesMuscular DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Berdine Martin, PhD

    Purdue University

    STUDY DIRECTOR

  • Connie Weaver, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 12, 2011

First Posted

April 5, 2012

Study Start

February 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

February 10, 2014

Record last verified: 2014-02

Locations

US(1)