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Soluble Corn Fiber and Calcium Utilization in Adolescents

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01571440
First Posted: April 5, 2012
Last Update Posted: February 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Tate and Lyle Ingredients Americas LLC
Information provided by (Responsible Party):
Berdine Martin, Purdue University
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Berdine Martin, Purdue University:

Primary Outcome Measures:
  • Calcium absorption and retention [ Time Frame: up to three weeks ]
  • Gut microbial profile [ Time Frame: up to three weeks ]

Secondary Outcome Measures:
  • Bone mineral content and density [ Time Frame: up to three weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Berdine Martin, Research Scientist, Nutrition Science, Purdue University
ClinicalTrials.gov Identifier: NCT01571440     History of Changes
Other Study ID Numbers: Camp Calcium 11-Tate and Lyle
First Submitted: January 12, 2011
First Posted: April 5, 2012
Last Update Posted: February 10, 2014
Last Verified: February 2014

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

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs