Fructooligosaccharide and Calcium Absorption in Adolescent Girls

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01005927

Enrollment

Registered

2009-11-02

Start date

2009-01-31

Completion date

2009-06-30

Last updated

2018-05-07

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

Conditions

Osteoporosis

Keywords

Calcium, Bone and Bones, Girls, Bone Mineralization, Fiber, Fructooligosaccharide, Female, Healthy, Adolescents

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.

Interventions

DIETARY_SUPPLEMENTFructooligosaccharide

Zero or 3 g of a fructooligosaccharide will be administered in a beverage containing 300 mg total calcium as well as 15 mg 44Ca (calcium carbonate). Participants will be given one of the above beverages in addition to intravenously receiving 5 mg 43Ca (calcium chloride)in 10 ml saline.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

10 Years to 12 Years

Healthy volunteers

Yes

Inclusion criteria

* Female * Calcium intake of 900-1300 mg/d * Generally healthy

Exclusion criteria

* Male * 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)

Design outcomes

Primary

Measure	Time frame
Fractional Calcium Absorption	24 h urine and 3 h blood

Secondary

Measure	Time frame
Bone density and geometry measured with peripheral quantitative computed tomography (pQCT)	Initial visit

Countries

United States

Outcome results

None listed

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