Soluble Corn Fiber and Calcium Utilization in Adolescents

Purdue University

Status: Completed

Conditions: Osteoporosis

Treatments: Dietary Supplement: No soluble corn fiber; Dietary Supplement: 12 g soluble corn fiber

Study type: Interventional

Funder types: Other

Identifiers

NCT01571440

Camp Calcium 11-Tate and Lyle

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 12 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

No Soluble Corn Fiber

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: No soluble corn fiber

12 g Soluble Corn Fiber

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: 12 g soluble corn fiber