Fructooligosaccharide and Calcium Absorption in Adolescent Girls

Osteoporosis Clinical Trial

Official title:

Fructooligosaccharide and Calcium Absorption in Adolescent Girls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01005927
• Other study ID #: GTC Study
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2009
• Est. completion date: June 2009

Study information

• Verified date: May 2018
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Purdue University	Abbott Nutrition, GTC Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional Calcium Absorption		24 h urine and 3 h blood
Secondary	Bone density and geometry measured with peripheral quantitative computed tomography (pQCT)		Initial visit