Galactooligosaccharide (GOS) Supplementation and Calcium Absorption in Girls (Friesland)
Primary Purpose
Osteoporosis
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Galactooligosaccharide
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring Dietary Supplement: Galactooligosaccharide
Eligibility 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
Sites / Locations
- Purdue University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
No Galactooligosaccharide
5 g Galactooligosaccharide
10 g Galactooligosaccharide
Arm Description
0 g galactooligosaccharide added to calcium-containing yogurt beverage
5 g galactooligosaccharide provided in two calcium-containing yogurt beverage (2.5 g in each drink) per day
10 g galactooligosaccharide added to two calcium-containing yogurt beverage (5 g in each drink) per day
Outcomes
Primary Outcome Measures
Calcium Absorption
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
Change in fecal microbiota
Full Information
NCT ID
NCT01263847
First Posted
March 29, 2010
Last Updated
May 3, 2018
Sponsor
Purdue University
Collaborators
Friesland Foods
1. Study Identification
Unique Protocol Identification Number
NCT01263847
Brief Title
Galactooligosaccharide (GOS) Supplementation and Calcium Absorption in Girls
Acronym
Friesland
Official Title
The Effect of Galactooligosaccharide (GOS) Supplementation on Calcium Absorption and Retention in Female Adolescent Girls
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2009 (Actual)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
Friesland Foods
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the effects of galactooligosaccharide (GOS) supplementation on calcium absorption and and gut microbe profiles.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Dietary Supplement: Galactooligosaccharide
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Galactooligosaccharide
Arm Type
Placebo Comparator
Arm Description
0 g galactooligosaccharide added to calcium-containing yogurt beverage
Arm Title
5 g Galactooligosaccharide
Arm Type
Active Comparator
Arm Description
5 g galactooligosaccharide provided in two calcium-containing yogurt beverage (2.5 g in each drink) per day
Arm Title
10 g Galactooligosaccharide
Arm Type
Active Comparator
Arm Description
10 g galactooligosaccharide added to two calcium-containing yogurt beverage (5 g in each drink) per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Galactooligosaccharide
Other Intervention Name(s)
Friesland
Intervention Description
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.
Primary Outcome Measure Information:
Title
Calcium Absorption
Description
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).
Time Frame
baseline and 48 h urine and blood
Secondary Outcome Measure Information:
Title
Change in fecal microbiota
Time Frame
after 3 weeks of product consumption
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie M Weaver, PhD
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Galactooligosaccharide (GOS) Supplementation and Calcium Absorption in Girls
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