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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):
Berdine Martin, Purdue University
ClinicalTrials.gov Identifier:
NCT01571440
First received: January 12, 2011
Last updated: February 7, 2014
Last verified: February 2014

January 12, 2011
February 7, 2014
February 2010
July 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01571440 on ClinicalTrials.gov Archive Site
Bone mineral content and density [ Time Frame: up to three weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Soluble Corn Fiber and Calcium Utilization in Adolescents
The Effect of Soluble Corn Fiber on Calcium Utilization and Retention and Gut Microflora in Adolescents

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Osteoporosis
  • 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
  • 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
  • Placebo Comparator: No Soluble Corn Fiber
    Each teen will receive a package of fruit snacks containing 0 g soluble corn fiber two times daily.
    Intervention: Dietary Supplement: No 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
    Intervention: Dietary Supplement: 12 g soluble corn fiber
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
12 Years to 15 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01571440
Camp Calcium 11-Tate and Lyle
No
Berdine Martin, Purdue University
Purdue University
Tate and Lyle Ingredients Americas LLC
Study Director: Berdine Martin, PhD Purdue University
Principal Investigator: Connie Weaver, PhD Purdue University
Purdue University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP