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

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ClinicalTrials.gov Identifier: NCT01263847
Recruitment Status : Completed
First Posted : December 21, 2010
Last Update Posted : January 14, 2011
Sponsor:
Collaborator:
Friesland Foods
Information provided by:
Purdue University

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

Condition or disease Intervention/treatment Phase
Osteoporosis Dietary Supplement: Galactooligosaccharide Early Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Galactooligosaccharide (GOS) Supplementation on Calcium Absorption and Retention in Female Adolescent Girls
Study Start Date : June 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: No Galactooligosaccharide
0 g galactooligosaccharide added to calcium-containing yogurt beverage
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
Active Comparator: 5 g Galactooligosaccharide
5 g galactooligosaccharide provided in two calcium-containing yogurt beverage (2.5 g in each drink) per day
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
Active Comparator: 10 g Galactooligosaccharide
10 g galactooligosaccharide added to two calcium-containing yogurt beverage (5 g in each drink) per day
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



Primary Outcome Measures :
  1. Calcium Absorption [ Time Frame: baseline and 48 h urine and blood ]
    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).


Secondary Outcome Measures :
  1. Change in fecal microbiota [ Time Frame: after 3 weeks of product consumption ]


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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 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

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): NCT01263847


Locations
United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Friesland Foods
Investigators
Principal Investigator: Connie M Weaver, PhD Purdue University

Responsible Party: Connie M Weaver, PhD, Purdue University
ClinicalTrials.gov Identifier: NCT01263847     History of Changes
Other Study ID Numbers: Friesland
First Posted: December 21, 2010    Key Record Dates
Last Update Posted: January 14, 2011
Last Verified: January 2011

Keywords provided by Purdue University:
Dietary Supplement: Galactooligosaccharide

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