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Soluble Corn Fiber and Calcium Utilization in Adolescents

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01571440
Enrollment
24
Registered
2012-04-05
Start date
2010-02-28
Completion date
2010-07-31
Last updated
2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

Bone, adolescents, fiber, healthy, boys, girls, camp, calcium

Brief summary

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.

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.

Interventions

DIETARY_SUPPLEMENTNo soluble corn fiber

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

DIETARY_SUPPLEMENT12 g soluble corn fiber

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

Sponsors

Tate and Lyle Ingredients Americas LLC
CollaboratorUNKNOWN
Purdue University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 15 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Calcium absorption and retentionup to three weeks
Gut microbial profileup to three weeks

Secondary

MeasureTime frame
Bone mineral content and densityup to three weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026