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OpenTrials
Completed

NCT Number: NCT01005927

Fructooligosaccharide and Calcium Absorption in Adolescent Girls

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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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

10 year–12 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Purdue University

West Lafayette, Indiana, 47907, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fructooligosaccharide

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.

Other names: Fiber and Calcium

Primary outcomes

  1. Fractional Calcium Absorption

    Time frame: 24 h urine and 3 h blood

Secondary outcomes

  1. Bone density and geometry measured with peripheral quantitative computed tomography (pQCT)

    Time frame: Initial visit

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • Abbott Nutrition
  • GTC Nutrition

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Nov 2, 2009
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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