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Fructooligosaccharide and Calcium Absorption in Adolescent Girls

Primary Purpose

Osteoporosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Fructooligosaccharide

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring Calcium, Bone and Bones, Girls, Bone Mineralization, Fiber, Fructooligosaccharide, Female, Healthy, Adolescents

Eligibility Criteria

10 Years - 12 Years (Child)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Female
Calcium intake of 900-1300 mg/d
Generally healthy

Exclusion Criteria:

Male
BMI > 90th percentile for age
Takes medication that influences calcium metabolism
Any disorder of calcium or bone homeostasis (hypercalcemia, Paget's Disease)
Smoking, illegal drug consumption
Any gastrointestinal disease (Crohn's Disease, Celiac Disease, Inflammatory Bowel Disease)

Sites / Locations

Purdue University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

No Fructooligosaccharide

3 g Fructooligosaccharide

Arm Description

0 g fructooligosaccharide added to calcium-containing beverage

3 g fructooligosaccharide added to calcium-containing beverage

Outcomes

Primary Outcome Measures

Fractional Calcium Absorption

Secondary Outcome Measures

Bone density and geometry measured with peripheral quantitative computed tomography (pQCT)

Full Information

NCT ID

NCT01005927

First Posted

October 30, 2009

Last Updated

May 2, 2018

Sponsor

Purdue University

Collaborators

Abbott Nutrition, GTC Nutrition

1. Study Identification

Unique Protocol Identification Number

NCT01005927

Brief Title

Fructooligosaccharide and Calcium Absorption in Adolescent Girls

Official Title

Fructooligosaccharide and Calcium Absorption in Adolescent Girls

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Purdue University

Collaborators

Abbott Nutrition, GTC Nutrition

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Fructooligosaccharides (FOS) are believed to have positive effects on calcium absorption and bone accrual during growth. This study aims to see whether the addition of fiber in the form of FOS to a calcium-containing beverage will increase calcium absorption. During two clinical visits, participants will receive a beverage containing a small amount of calcium, supplemented with either no dietary fiber or a small amount of fiber. Height, weight, bone density and geometry, calcium absorption, and physical fitness will be measured. The effects of this fiber intervention may provide support for improving bone health with minimal fiber supplementation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

Keywords

Calcium, Bone and Bones, Girls, Bone Mineralization, Fiber, Fructooligosaccharide, Female, Healthy, Adolescents

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

No Fructooligosaccharide

Arm Type

Placebo Comparator

Arm Description

0 g fructooligosaccharide added to calcium-containing beverage

Arm Title

3 g Fructooligosaccharide

Arm Type

Active Comparator

Arm Description

3 g fructooligosaccharide added to calcium-containing beverage

Intervention Type

Dietary Supplement

Intervention Name(s)

Fructooligosaccharide

Other Intervention Name(s)

Fiber and Calcium

Intervention Description

Zero or 3 g of a fructooligosaccharide will be administered in a beverage containing 300 mg total calcium as well as 15 mg 44Ca (calcium carbonate). Participants will be given one of the above beverages in addition to intravenously receiving 5 mg 43Ca (calcium chloride)in 10 ml saline.

Primary Outcome Measure Information:

Title

Fractional Calcium Absorption

Time Frame

24 h urine and 3 h blood

Secondary Outcome Measure Information:

Title

Bone density and geometry measured with peripheral quantitative computed tomography (pQCT)

Time Frame

Initial visit

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female Calcium intake of 900-1300 mg/d Generally healthy Exclusion Criteria: Male BMI > 90th percentile for age Takes medication that influences calcium metabolism Any disorder of calcium or bone homeostasis (hypercalcemia, Paget's Disease) Smoking, illegal drug consumption Any gastrointestinal disease (Crohn's Disease, Celiac Disease, Inflammatory Bowel Disease)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Connie M Weaver, PhD

Organizational Affiliation

Purdue University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Berdine R Martin, PhD

Organizational Affiliation

Purdue University

Official's Role

Study Director

Facility Information:

Facility Name

Purdue University

City

West Lafayette

State/Province

Indiana

ZIP/Postal Code

47907

Country

United States

12. IPD Sharing Statement

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Fructooligosaccharide and Calcium Absorption in Adolescent Girls

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