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Fructooligosaccharide and Calcium Absorption in Adolescent Girls

Purdue University logo

Purdue University

Status and phase

Completed
Phase 2
Phase 1

Conditions

Osteoporosis

Treatments

Dietary Supplement: Fructooligosaccharide

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01005927
GTC Study

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

Female

Ages

10 to 12 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

26 participants in 2 patient groups, including a placebo group

No Fructooligosaccharide
Placebo Comparator group
Description:
0 g fructooligosaccharide added to calcium-containing beverage
Treatment:
Dietary Supplement: Fructooligosaccharide
3 g Fructooligosaccharide
Active Comparator group
Description:
3 g fructooligosaccharide added to calcium-containing beverage
Treatment:
Dietary Supplement: Fructooligosaccharide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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