OsteoporosisPhase 1/2NCT01005927
Fructooligosaccharide and Calcium Absorption in Adolescent Girls
A Phase 1/2 study testing Fructooligosaccharide in people with Osteoporosis, run by Purdue University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 12 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Fructooligosaccharide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jun 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Female
- Calcium intake of 900-1300 mg/d
- Generally healthy
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Osteoporosis
- Being tested
- Fructooligosaccharide
- Keywords
- Calcium, Bone and Bones, Girls, Bone Mineralization, Fiber, Fructooligosaccharide, Female, Healthy, Adolescents
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FructooligosaccharideDietary supplement
Also called Fiber and Calcium
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.
| Study group | Role | What they receive |
|---|---|---|
| No Fructooligosaccharide | Placebo comparator | 0 g fructooligosaccharide added to calcium-containing beverage Receives: Dietary Supplement: Fructooligosaccharide |
| 3 g Fructooligosaccharide | Active comparator | 3 g fructooligosaccharide added to calcium-containing beverage Receives: Dietary Supplement: Fructooligosaccharide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional Calcium Absorption
Measured: 24 h urine and 3 h blood
Secondary outcomes (1)
Bone density and geometry measured with peripheral quantitative computed tomography (pQCT)
Measured: Initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Nutrition, GTC Nutrition
- Responsible party
- Principal investigator, Berdine Martin, Purdue University
- Investigators
- Connie M Weaver, PhD, Principal investigator, Purdue UniversityBerdine R Martin, PhD, Study director, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005927
- Sponsor's protocol ID
- GTC Study
- Status last verified
- May 2018
- First submitted
- 30 Oct 2009
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fructooligosaccharide and Calcium Absorption in Adolescent Girls
- ClinicalTrials.gov ID
- NCT01005927
- Acronym / sponsor ID
- GTC Study
- Conditions
- Osteoporosis
- Keywords
- Calcium, Bone and Bones, Girls, Bone Mineralization, Fiber, Fructooligosaccharide, Female, Healthy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Abbott Nutrition, GTC Nutrition
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 2 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Fructooligosaccharide | Placebo comparator | Dietary Supplement: Fructooligosaccharide0 g fructooligosaccharide added to calcium-containing beverage |
| 3 g Fructooligosaccharide | Active comparator | Dietary Supplement: Fructooligosaccharide3 g fructooligosaccharide added to calcium-containing beverage |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Female
- Calcium intake of 900-1300 mg/d
- Generally healthy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FructooligosaccharideAlso: Fiber and CalciumZero 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. | Dietary supplement | 3 g Fructooligosaccharide, No Fructooligosaccharide |
Primary outcome
Fractional Calcium Absorption
Time frame: 24 h urine and 3 h blood
1 secondary outcome
Bone density and geometry measured with peripheral quantitative computed tomography (pQCT)
Time frame: Initial visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Connie M Weaver, PhD principal investigator
Purdue University
Berdine R Martin, PhD study director
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fructooligosaccharide in people with Osteoporosis, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional Calcium Absorption (time frame: 24 h urine and 3 h blood). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.