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Soluble Corn Fiber and Calcium Utilization in Adolescents

This study has been completed.
Sponsor:
Collaborator:
Tate and Lyle Ingredients Americas LLC
Information provided by (Responsible Party):
Purdue University
ClinicalTrials.gov Identifier:
NCT01571440
First received: January 12, 2011
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Osteoporosis
 Dietary Supplement: No soluble corn fiber
Dietary Supplement: 12 g soluble corn fiber

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Soluble Corn Fiber on Calcium Utilization and Retention and Gut Microflora in Adolescents

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Purdue University:

Primary Outcome Measures:
  • Calcium absorption and retention [ Time Frame: up to three weeks ] [ Designated as safety issue: No ]
  • Gut microbial profile [ Time Frame: up to three weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone mineral content and density [ Time Frame: up to three weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: February 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: soluble corn fiber

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.

  Eligibility

Ages Eligible for Study:   12 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571440

Locations
United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Tate and Lyle Ingredients Americas LLC
Investigators
Study Director: Berdine Martin, PhD Purdue University
Principal Investigator: Connie Weaver, PhD Purdue University
  More Information

No publications provided

Responsible Party: Purdue University
ClinicalTrials.gov Identifier: NCT01571440     History of Changes
Other Study ID Numbers: Camp Calcium 11-Tate and Lyle
Study First Received: January 12, 2011
Last Updated: April 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Purdue University:
Bone
adolescents
fiber
healthy
 boys
girls
camp
calcium

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 16, 2013