Fructooligosaccharide and Calcium Absorption in Adolescent Girls

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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No Fructooligosaccharide

0 g fructooligosaccharide added to calcium-containing beverage

Group Type PLACEBO_COMPARATOR

Fructooligosaccharide

Intervention Type DIETARY_SUPPLEMENT

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.

3 g Fructooligosaccharide

3 g fructooligosaccharide added to calcium-containing beverage

Group Type ACTIVE_COMPARATOR

Fructooligosaccharide

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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Fructooligosaccharide

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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Fiber and Calcium

Eligibility Criteria

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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)

Minimum Eligible Age

10 Years

Maximum Eligible Age

12 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes