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Galactooligosaccharide (GOS) Supplementation and Calcium Absorption in Girls (Friesland)

This study has been completed.
Sponsor:
Collaborator:
Friesland Foods
Information provided by:
Purdue University
ClinicalTrials.gov Identifier:
NCT01263847
First received: March 29, 2010
Last updated: January 12, 2011
Last verified: January 2011
History of Changes

March 29, 2010
January 12, 2011
June 2009
July 2010   (final data collection date for primary outcome measure)
Calcium Absorption [ Time Frame: baseline and 48 h urine and blood ] [ Designated as safety issue: No ]
Calcium absorption will be measured using dual isotope methods. Calcium-44(Ca-44) as calcium chloride will be administered in a yogurt drink provided at breakfast along with a roll, butter, jam and juice. A second isotope, Calcium-43 (Ca-43) as calcium chloride will be administered intravenously, one hour after consumption of breakfast. Urine and blood samples will be collected over a period of 48 hours and levels of Ca-44 and Ca-43 will be measured in urine and blood. Levels of Ca-44 and Ca-43 will be expressed as a ratio (Ca-44/Ca-43).
Calcium Absorption [ Time Frame: 48 h urine and blood ] [ Designated as safety issue: No ]
Calcium absorption will be measured using dual isotope methods. 44Ca as calcium chloride will be administered in a yogurt smoothie provided at breakfast along with a role, butter, jam and juice. A second isotope, 43Ca as calcium chloride will be administered intravenously, one hour after consumption of breakfast. Urine and blood samples will be collected over a period of 48 hours and levels of 44Ca and 43Ca will be measured in urine and blood. Levels of 44Ca and 43Ca will be expressed as a ratio representative of calcium absorption.
Complete list of historical versions of study NCT01263847 on ClinicalTrials.gov Archive Site
Change in fecal microbiota [ Time Frame: after 3 weeks of product consumption ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Galactooligosaccharide (GOS) Supplementation and Calcium Absorption in Girls
The Effect of Galactooligosaccharide (GOS) Supplementation on Calcium Absorption and Retention in Female Adolescent Girls

The purpose of this study is to determine the effects of galactooligosaccharide (GOS) supplementation on calcium absorption and and gut microbe profiles.

Galactooligosaccharides (GOS) have been shown to have positive effects on calcium absorption in animals and postmenopausal women. This study aims to see whether the addition of fiber in the form of GOS to a calcium-containing yogurt drink will increase calcium absorption compared to placebo in a group of girls near menarche. Secondary outcomes are to assess physical fitness and determine the relationship between physical fitness and calcium absorption in adolescent girls as well as assess changes in gut microbiota. During this three phase, randomized, controlled crossover study, participants will consume yogurt drinks supplemented with 0, 2.5 or 5 grams of GOS twice daily for three weeks. Following each three week period, participants will complete a weekend clinical visit to measure calcium absorption. Height, weight, bone density and geometry, calcium absorption, gut microbiota and physical fitness will be measured. Effects of this GOS fiber intervention may help elucidate a mechanism of action for improving bone health with fiber supplementation.
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Osteoporosis
Dietary Supplement: Galactooligosaccharide
Zero, 5 or 10 g/day of galactooligosaccharide will be administered in two yogurt drinks containing about 300 mg total calcium each per day for three weeks. During a clinical visit following three weeks of consumption, zero, 2.5 or 5 g of galactooligosaccharide will be administered in the same yogurt with the addition of 15 mg Ca-44 (calcium chloride). Participants will be given one of the above yogurts at breakfast in addition to intravenously receiving 3.5 mg Ca-43 (calcium chloride) in 4 ml saline one hour after breakfast consumption.
Other Name: Friesland
  • Placebo Comparator: No Galactooligosaccharide
    0 g galactooligosaccharide added to calcium-containing yogurt beverage
    Intervention: Dietary Supplement: Galactooligosaccharide
  • Active Comparator: 5 g Galactooligosaccharide
    5 g galactooligosaccharide provided in two calcium-containing yogurt beverage (2.5 g in each drink) per day
    Intervention: Dietary Supplement: Galactooligosaccharide
  • Active Comparator: 10 g Galactooligosaccharide
    10 g galactooligosaccharide added to two calcium-containing yogurt beverage (5 g in each drink) per day
    Intervention: Dietary Supplement: Galactooligosaccharide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female between ages of 10 and 12
  • Calcium intake of 900-1300 mg/d

Exclusion Criteria:

  • Take medication that influences calcium metabolism
  • Any disorder of calcium or bone homeostasis
  • BMI>90th percentile for age
  • Smoking, illegal drug consumption
  • Any gastrointestinal disease (crohn's disease, celiac disease, inflammatory bowel disease)
  • Any disease affecting kidney function
  • Broken bone within last 6 months
  • Dislike of yogurt or yogurt drinks
  • Regular use of foods containing probiotics or prebiotics
Female
10 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01263847
Friesland
No
Connie M Weaver, PhD, Purdue University
Purdue University
Friesland Foods
Principal Investigator: Connie M Weaver, PhD Purdue University
Purdue University
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP