Soluble Corn Fiber and Calcium Utilization in Adolescents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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No Soluble Corn Fiber

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

Group Type PLACEBO_COMPARATOR

No soluble corn fiber

Intervention Type DIETARY_SUPPLEMENT

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

12 g Soluble Corn Fiber

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

Group Type ACTIVE_COMPARATOR

12 g soluble corn fiber

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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No soluble corn fiber

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

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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soluble corn fiber soluble corn fiber

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes