Trial | NCT01263847  Report issue

Title

Galactooligosaccharide (GOS) Supplementation and Calcium Absorption in Girls
The Effect of Galactooligosaccharide (GOS) Supplementation on Calcium Absorption and Retention in Female Adolescent Girls

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    31
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.
Study Started
Jun 30
2009
Primary Completion
Jul 31
2010
Study Completion
Jul 31
2010
Last Update
May 09
2018

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 names: Friesland

No Galactooligosaccharide Placebo Comparator

0 g galactooligosaccharide added to calcium-containing yogurt beverage

5 g Galactooligosaccharide Active Comparator

5 g galactooligosaccharide provided in two calcium-containing yogurt beverage (2.5 g in each drink) per day

10 g Galactooligosaccharide Active Comparator

10 g galactooligosaccharide added to two calcium-containing yogurt beverage (5 g in each drink) per day

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
No Results Posted