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Fructooligosaccharide and Calcium Absorption in Adolescent Girls

This study has been completed.
Sponsor:
Collaborators:
Abbott Nutrition
GTC Nutrition
Information provided by:
Purdue University
ClinicalTrials.gov Identifier:
NCT01005927
First received: October 30, 2009
Last updated: July 27, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Osteoporosis
 Dietary Supplement: Fructooligosaccharide
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Fructooligosaccharide and Calcium Absorption in Adolescent Girls

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Purdue University:

Primary Outcome Measures:
  • Fractional Calcium Absorption [ Time Frame: 24 h urine and 3 h blood ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone density and geometry measured with peripheral quantitative computed tomography (pQCT) [ Time Frame: Initial visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: January 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: No Fructooligosaccharide
0 g fructooligosaccharide added to calcium-containing beverage
 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.
Other Name: Fiber and Calcium
Active Comparator: 3 g Fructooligosaccharide
3 g fructooligosaccharide added to calcium-containing beverage
 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.
Other Name: Fiber and Calcium

  Eligibility

Ages Eligible for Study:   10 Years to 12 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005927

Locations
United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Abbott Nutrition
GTC Nutrition
Investigators
Principal Investigator: Connie M Weaver, PhD Purdue University
Study Director: Berdine R Martin, PhD Purdue University
  More Information

No publications provided

Responsible Party: Connie M Weaver, PhD, Purdue University
ClinicalTrials.gov Identifier: NCT01005927     History of Changes
Other Study ID Numbers: GTC Study
Study First Received: October 30, 2009
Last Updated: July 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Purdue University:
Calcium
Bone and Bones
Girls
Bone Mineralization
Fiber
 Fructooligosaccharide
Female
Healthy
Adolescents

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013