Galactooligosaccharide (GOS) Supplementation and Calcium Absorption in Girls

Early Phase 1

Completed

• Conditions: Osteoporosis
• Interventions: Dietary Supplement: Galactooligosaccharide

• Registration Number: NCT01263847
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-03-29
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Submitted QC: 2010-12-17
• Study First Posted: 2010-12-21
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
5 g Galactooligosaccharide	Galactooligosaccharide	5 g galactooligosaccharide provided in two calcium-containing yogurt beverage (2.5 g in each drink) per day
No Galactooligosaccharide	Galactooligosaccharide	0 g galactooligosaccharide added to calcium-containing yogurt beverage
10 g Galactooligosaccharide	Galactooligosaccharide	10 g galactooligosaccharide added to two calcium-containing yogurt beverage (5 g in each drink) per day

Primary Outcome Measures

Name	Time	Method
Calcium Absorption	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

Name	Time	Method
Change in fecal microbiota	after 3 weeks of product consumption

Trial Locations

Locations (1)

Purdue University; 🇺🇸 West Lafayette, Indiana, United States