Galactooligosaccharide (GOS) Supplementation and Calcium Absorption in Girls

NCT01263847 | Completed Early Phase 1

• 1 other identifier: Friesland
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoporosis

Keywords

Dietary Supplement: Galactooligosaccharide

Outcome Measures

Primary Outcomes (1)

• 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).

  baseline and 48 h urine and blood

Secondary Outcomes (1)

• Change in fecal microbiota

  after 3 weeks of product consumption

Study Arms (3)

No Galactooligosaccharide

PLACEBO COMPARATOR

0 g galactooligosaccharide added to calcium-containing yogurt beverage

Dietary Supplement: Galactooligosaccharide

5 g Galactooligosaccharide

ACTIVE COMPARATOR

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

Dietary Supplement: Galactooligosaccharide

10 g Galactooligosaccharide

ACTIVE COMPARATOR

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

Dietary Supplement: Galactooligosaccharide

Interventions

Galactooligosaccharide 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.

Also known as: Friesland

10 g Galactooligosaccharide; 5 g Galactooligosaccharide; No Galactooligosaccharide

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Female between ages of 10 and 12
• Calcium intake of 900-1300 mg/d

You may not qualify if:

• 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

Sponsors & Collaborators

• Purdue University: lead
• Friesland Foods: collaborator

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

4'-galactooligosaccharide

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Connie M Weaver, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist, Nutrition Science

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: December 21, 2010
• Study Start: June 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: May 9, 2018

Record last verified: 2018-05

Locations

US (1)