NCT01005927

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
Last Updated

May 7, 2018

Status Verified

May 1, 2018

Enrollment Period

5 months

First QC Date

October 30, 2009

Last Update Submit

May 2, 2018

Conditions

Osteoporosis

Keywords

CalciumBone and BonesGirlsBone MineralizationFiberFructooligosaccharideFemaleHealthyAdolescents

Outcome Measures

Primary Outcomes (1)

  • Fractional Calcium Absorption

    24 h urine and 3 h blood

Secondary Outcomes (1)

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

    Initial visit

Study Arms (2)

No Fructooligosaccharide

PLACEBO COMPARATOR

0 g fructooligosaccharide added to calcium-containing beverage

Dietary Supplement: Fructooligosaccharide

3 g Fructooligosaccharide

ACTIVE COMPARATOR

3 g fructooligosaccharide added to calcium-containing beverage

Dietary Supplement: Fructooligosaccharide

Interventions

FructooligosaccharideDIETARY_SUPPLEMENT

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.

Also known as: Fiber and Calcium
3 g FructooligosaccharideNo Fructooligosaccharide

Eligibility Criteria

Age10 Years - 12 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

fructooligosaccharideDietary FiberCalcium

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Connie M Weaver, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

  • Berdine R Martin, PhD

    Purdue University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 30, 2009

First Posted

November 2, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

May 7, 2018

Record last verified: 2018-05

Locations

US(1)