Galactooligosaccharide (GOS) Supplementation and Calcium Absorption in Girls

NCT ID: NCT01263847

Last Updated: 2018-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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No Galactooligosaccharide

0 g galactooligosaccharide added to calcium-containing yogurt beverage

Group Type PLACEBO_COMPARATOR

Galactooligosaccharide

Intervention Type DIETARY_SUPPLEMENT

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.

5 g Galactooligosaccharide

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

Group Type ACTIVE_COMPARATOR

Galactooligosaccharide

Intervention Type DIETARY_SUPPLEMENT

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.

10 g Galactooligosaccharide

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

Group Type ACTIVE_COMPARATOR

Galactooligosaccharide

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Friesland

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

12 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Friesland Foods

UNKNOWN

Sponsor Role collaborator

Purdue University

OTHER

Sponsor Role lead

Responsible Party

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Berdine Martin

Research Scientist, Nutrition Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Connie M Weaver, PhD

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

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Purdue University

West Lafayette, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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Friesland

Identifier Type: -

Identifier Source: org_study_id

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