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Clinical Trials/NCT01005927
NCT01005927CompletedPhase 1

Fructooligosaccharide and Calcium Absorption in Adolescent Girls

Purdue University2 sites in 1 country26 target enrollmentStarted: January 2009Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
26
Locations
2
Primary Endpoint
Fractional Calcium Absorption

Study Overview

Brief Summary

Fructooligosaccharides (FOS) are believed to have positive effects on calcium absorption and bone accrual during growth. This study aims to see whether the addition of fiber in the form of FOS to a calcium-containing beverage will increase calcium absorption. During two clinical visits, participants will receive a beverage containing a small amount of calcium, supplemented with either no dietary fiber or a small amount of fiber. Height, weight, bone density and geometry, calcium absorption, and physical fitness will be measured. The effects of this fiber intervention may provide support for improving bone health with minimal fiber supplementation.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
10 Years to 12 Years (Child)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Calcium intake of 900-1300 mg/d
  • Generally healthy

Exclusion Criteria

  • BMI > 90th percentile for age
  • Takes medication that influences calcium metabolism
  • Any disorder of calcium or bone homeostasis (hypercalcemia, Paget's Disease)
  • Smoking, illegal drug consumption
  • Any gastrointestinal disease (Crohn's Disease, Celiac Disease, Inflammatory Bowel Disease)

Outcomes

Primary Outcomes

Fractional Calcium Absorption

Time Frame: 24 h urine and 3 h blood

Secondary Outcomes

  • Bone density and geometry measured with peripheral quantitative computed tomography (pQCT)(Initial visit)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Berdine Martin

Research Scientist, Nutrition Science

Purdue University

Study Sites (2)

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