Soluble Corn Fiber and Calcium Utilization in Adolescents

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571440
• Other study ID #: Camp Calcium 11-Tate and Lyle
• Status: Completed
• Phase: N/A
• First received: January 12, 2011
• Last updated: February 7, 2014
• Start date: February 2010
• Est. completion date: July 2010

Study information

• Verified date: February 2014
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 15 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	Tate and Lyle Ingredients Americas LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calcium absorption and retention		up to three weeks	No
Primary	Gut microbial profile		up to three weeks	No
Secondary	Bone mineral content and density		up to three weeks	No