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Completed

NCT Number: NCT01571440

Soluble Corn Fiber and Calcium Utilization 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.

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Key information

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47907, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No soluble corn fiber

Dietary Supplement

Each teen will receive a package of fruit snacks containing 0 g soluble corn fiber two times per day

Other names: soluble corn fiber

12 g soluble corn fiber

Dietary Supplement

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

Other names: soluble corn fiber

Primary outcomes

  1. Calcium absorption and retention

    Time frame: up to three weeks

  2. Gut microbial profile

    Time frame: up to three weeks

Secondary outcomes

  1. Bone mineral content and density

    Time frame: up to three weeks

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • Tate and Lyle Ingredients Americas LLC

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 5, 2012
Registry last updated
Feb 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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