Soluble Corn Fiber and Calcium Utilization in Adolescents
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No soluble corn fiber
12 g soluble corn fiber
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring Bone, adolescents, fiber, healthy, boys, girls, camp, calcium
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
Sites / Locations
- Purdue University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
No Soluble Corn Fiber
12 g Soluble Corn Fiber
Arm Description
Each teen will receive a package of fruit snacks containing 0 g soluble corn fiber two times daily.
Each teen will receive a package of fruit snacks containing 6 g soluble corn fiber two times daily
Outcomes
Primary Outcome Measures
Calcium absorption and retention
Gut microbial profile
Secondary Outcome Measures
Bone mineral content and density
Full Information
NCT ID
NCT01571440
First Posted
January 12, 2011
Last Updated
February 7, 2014
Sponsor
Purdue University
Collaborators
Tate and Lyle Ingredients Americas LLC
1. Study Identification
Unique Protocol Identification Number
NCT01571440
Brief Title
Soluble Corn Fiber and Calcium Utilization in Adolescents
Official Title
The Effect of Soluble Corn Fiber on Calcium Utilization and Retention and Gut Microflora in Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
Tate and Lyle Ingredients Americas LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Bone, adolescents, fiber, healthy, boys, girls, camp, calcium
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Soluble Corn Fiber
Arm Type
Placebo Comparator
Arm Description
Each teen will receive a package of fruit snacks containing 0 g soluble corn fiber two times daily.
Arm Title
12 g Soluble Corn Fiber
Arm Type
Active Comparator
Arm Description
Each teen will receive a package of fruit snacks containing 6 g soluble corn fiber two times daily
Intervention Type
Dietary Supplement
Intervention Name(s)
No soluble corn fiber
Other Intervention Name(s)
soluble corn fiber
Intervention Description
Each teen will receive a package of fruit snacks containing 0 g soluble corn fiber two times per day
Intervention Type
Dietary Supplement
Intervention Name(s)
12 g soluble corn fiber
Other Intervention Name(s)
soluble corn fiber
Intervention Description
Each teen will receive a package of fruit snacks containing 6 g soluble corn fiber two times per day.
Primary Outcome Measure Information:
Title
Calcium absorption and retention
Time Frame
up to three weeks
Title
Gut microbial profile
Time Frame
up to three weeks
Secondary Outcome Measure Information:
Title
Bone mineral content and density
Time Frame
up to three weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berdine Martin, PhD
Organizational Affiliation
Purdue University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Connie Weaver, PhD
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States
12. IPD Sharing Statement
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Soluble Corn Fiber and Calcium Utilization in Adolescents
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