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Fructooligosaccharide and Calcium Absorption in Adolescent Girls

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ClinicalTrials.gov Identifier: NCT01005927
Recruitment Status : Completed
First Posted : November 2, 2009
Last Update Posted : May 7, 2018
Sponsor:
Collaborators:
Abbott Nutrition
GTC Nutrition
Information provided by (Responsible Party):
Berdine Martin, Purdue University

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Dietary Supplement: Fructooligosaccharide Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Fructooligosaccharide and Calcium Absorption in Adolescent Girls
Study Start Date : January 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Fractional Calcium Absorption [ Time Frame: 24 h urine and 3 h blood ]

Secondary Outcome Measures :
  1. Bone density and geometry measured with peripheral quantitative computed tomography (pQCT) [ Time Frame: Initial visit ]


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Ages Eligible for Study:   10 Years to 12 Years   (Child)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Berdine Martin, Research Scientist, Nutrition Science, Purdue University
ClinicalTrials.gov Identifier: NCT01005927     History of Changes
Other Study ID Numbers: GTC Study
First Posted: November 2, 2009    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018

Keywords provided by Berdine Martin, 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
Metabolic Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs