Soluble Corn Fiber and Calcium Utilization in Adolescents

This study has been completed.

Sponsor:

Collaborator:

Tate and Lyle Ingredients Americas LLC

Information provided by (Responsible Party):

Purdue University

ClinicalTrials.gov Identifier:

NCT01571440

First received: January 12, 2011

Last updated: April 4, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 12, 2011

Last Updated Date

April 4, 2012

Start Date ^ICMJE

February 2010

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Calcium absorption and retention [ Time Frame: up to three weeks ] [ Designated as safety issue: No ]
Gut microbial profile [ Time Frame: up to three weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01571440 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Bone mineral content and density [ Time Frame: up to three weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Soluble Corn Fiber and Calcium Utilization in Adolescents

Official Title ^ICMJE

The Effect of Soluble Corn Fiber on Calcium Utilization and Retention and Gut Microflora in Adolescents

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.

Detailed Description

In a previous study, soluble corn fiber (SCF) was found to greatly enhance calcium utilization and bone properties in a growing rat model. Because factors that enhance bone density and mineral content can potentially result in a skeleton that will resist fracture later in life, it is important to investigate this potential in adolescents. Therefore, the objective of this study was to determine the effect of SCF on calcium absorption and retention in adolescent boys and girls. A second objective of this study was to assess whether additional dietary fiber leads to changes in gut microflora which may influence calcium absorption. During this two-phase metabolic camp participants consumed packages of fruit snacks supplemented with either 0 or 6 grams of soluble corn fiber twice a day during the first phase of the study, and switch to the opposite treatment during the second phase, with a 2-week washout period in between. Subjects collected all excreta during both phases and calcium absorption, gut microbiota, height, weight, and bone density were evaluated throughout the 6-week period of the study.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Osteoporosis

Intervention ^ICMJE

Dietary Supplement: No soluble corn fiber
Each teen will receive a package of fruit snacks containing 0 g soluble corn fiber two times per day

Other Name: soluble corn fiber
Dietary Supplement: 12 g soluble corn fiber
Each teen will receive a package of fruit snacks containing 6 g soluble corn fiber two times per day.

Other Name: soluble corn fiber

Study Arm (s)

Placebo Comparator: No Soluble Corn Fiber
Each teen will receive a package of fruit snacks containing 0 g soluble corn fiber two times daily.

Intervention: Dietary Supplement: No soluble corn fiber
Active Comparator: 12 g Soluble Corn Fiber
Each teen will receive a package of fruit snacks containing 6 g soluble corn fiber two times daily

Intervention: Dietary Supplement: 12 g soluble corn fiber

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2010

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

12 Years to 15 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01571440

Other Study ID Numbers ^ICMJE

Camp Calcium 11-Tate and Lyle

Has Data Monitoring Committee

Responsible Party

Purdue University

Study Sponsor ^ICMJE

Purdue University

Collaborators ^ICMJE

Tate and Lyle Ingredients Americas LLC

Investigators ^ICMJE

Study Director:	Berdine Martin, PhD	Purdue University
Principal Investigator:	Connie Weaver, PhD	Purdue University

Information Provided By

Purdue University

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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