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

May 3, 2018 updated by: Berdine Martin, Purdue University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

31

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • West Lafayette, Indiana, United States, 47907
        • Purdue University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Friesland

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
baseline and 48 h urine and blood

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in fecal microbiota
Time Frame: after 3 weeks of product consumption
after 3 weeks of product consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Collaborators

Friesland Foods

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2009

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

March 29, 2010

First Submitted That Met QC Criteria

December 17, 2010

First Posted (ESTIMATE)

December 21, 2010

Study Record Updates

Last Update Posted (ACTUAL)

May 9, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Friesland

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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