Soluble Corn Fiber and Calcium Utilization in Adolescents

Study Overview
=================
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.

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

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Dietary Supplement: No soluble corn fiber
* Dietary Supplement: 12 g soluble corn fiber


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No Soluble Corn Fiber<br>Each teen will receive a package of fruit snacks containing 0 g soluble corn fiber two times daily. | Dietary Supplement: No soluble corn fiber<br>* Each teen will receive a package of fruit snacks containing 0 g soluble corn fiber two times per day<br>* Other names: soluble corn fiber;|
| Active Comparator: 12 g Soluble Corn Fiber<br>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<br>* Each teen will receive a package of fruit snacks containing 6 g soluble corn fiber two times per day.<br>* Other names: soluble corn fiber;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcium absorption and retention |  | up to three weeks | 
| Gut microbial profile |  | up to three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral content and density |  | up to three weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fiber, adolescents, healthy, boys, girls, camp, calcium, Bone