Soluble Corn Fiber and Calcium Utilization in Adolescents

February 7, 2014 updated by: Berdine Martin, Purdue University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • West Lafayette, Indiana, United States, 47907
        • Purdue University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: No Soluble Corn Fiber
Each teen will receive a package of fruit snacks containing 0 g soluble corn fiber two times daily.
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 Names:
  • 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
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 Names:
  • soluble corn fiber

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Calcium absorption and retention
Time Frame: up to three weeks
up to three weeks
Gut microbial profile
Time Frame: up to three weeks
up to three weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Bone mineral content and density
Time Frame: up to three weeks
up to three weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Collaborators

Tate and Lyle Ingredients Americas LLC

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

January 12, 2011

First Submitted That Met QC Criteria

April 4, 2012

First Posted (Estimate)

April 5, 2012

Study Record Updates

Last Update Posted (Estimate)

February 10, 2014

Last Update Submitted That Met QC Criteria

February 7, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Camp Calcium 11-Tate and Lyle

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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