OsteoporosisNCT01571440
Soluble Corn Fiber and Calcium Utilization in Adolescents
A study testing No soluble corn fiber and 12 g soluble corn fiber in people with Osteoporosis, run by Purdue University at 1 site in United States.
Trial summary
The purpose of this study was to determine the effect of soluble corn fiber on calcium absorption and retention and gut microflora in adolescent boys and girls. Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- No soluble corn fiber and 12 g soluble corn fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jul 2010
- Phase
- Interventional
- 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 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Normal, healthy, white adolescents (Hispanic or non-Hispanic)
- Boys age 13-15
- Girls age 12-14
Who cannot join
- Abnormal kidney or liver function
- Malabsorptive disorders
- Anemia
- Smoking
- History of medications that affect calcium metabolism
- Body weight outside 5-95 percentile body mass index (BMI) for age
Show all 9Show fewer
- Regular consumption of illegal drugs
- Contraceptive use
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Soluble Corn Fiber on Calcium Utilization and Retention and Gut Microflora in Adolescents
The purpose of this study was to determine the effect of soluble corn fiber on calcium absorption and retention and gut microflora in adolescent boys and girls.
Read the detailed description
In a previous study, soluble corn fiber (SCF) was found to greatly enhance calcium utilization and bone properties in a growing rat model. Because factors that enhance bone density and mineral content can potentially result in a skeleton that will resist fracture later in life, it is important to investigate this potential in adolescents. Therefore, the objective of this study was to determine the effect of SCF on calcium absorption and retention in adolescent boys and girls. A second objective of this study was to assess whether additional dietary fiber leads to changes in gut microflora which may influence calcium absorption. During this two-phase metabolic camp participants consumed packages of fruit snacks supplemented with either 0 or 6 grams of soluble corn fiber twice a day during the first phase of the study, and switch to the opposite treatment during the second phase, with a 2-week washout period in between. Subjects collected all excreta during both phases and calcium absorption, gut microbiota, height, weight, and bone density were evaluated throughout the 6-week period of the study.
- Conditions
- Osteoporosis
- Being tested
- No soluble corn fiber, 12 g soluble corn fiber
- Keywords
- Bone, adolescents, fiber, healthy, boys, girls, camp, calcium
- Medical subject headings
- Osteoporosis, Muscle Cramp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No soluble corn fiberDietary supplement
Also called soluble corn fiber
Each teen will receive a package of fruit snacks containing 0 g soluble corn fiber two times per day
12 g soluble corn fiberDietary supplement
Also called soluble corn fiber
Each teen will receive a package of fruit snacks containing 6 g soluble corn fiber two times per day.
| Study group | Role | What they receive |
|---|---|---|
| No Soluble Corn Fiber | Placebo comparator | Each teen will receive a package of fruit snacks containing 0 g soluble corn fiber two times daily. Receives: Dietary Supplement: No soluble corn fiber |
| 12 g Soluble Corn Fiber | Active comparator | Each teen will receive a package of fruit snacks containing 6 g soluble corn fiber two times daily Receives: Dietary Supplement: 12 g soluble corn fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium absorption and retention
Measured: up to three weeks
Gut microbial profile
Measured: up to three weeks
Secondary outcomes (1)
Bone mineral content and density
Measured: up to three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startFeb 2010
- Primary completionJul 2010
- Study completionJul 2010
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Tate and Lyle Ingredients Americas LLC
- Responsible party
- Principal investigator, Berdine Martin, Purdue University
- Investigators
- Berdine Martin, PhD, Study director, Purdue UniversityConnie Weaver, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571440
- Sponsor's protocol ID
- Camp Calcium 11-Tate and Lyle
- Status last verified
- Feb 2014
- First submitted
- 12 Jan 2011
- Last updated
- 10 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Soluble Corn Fiber on Calcium Utilization and Retention and Gut Microflora in Adolescents
- ClinicalTrials.gov ID
- NCT01571440
- Acronym / sponsor ID
- Camp Calcium 11-Tate and Lyle
- Conditions
- Osteoporosis
- Keywords
- Bone, adolescents, fiber, healthy, boys, girls, camp, calcium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Tate and Lyle Ingredients Americas LLC
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 5 Apr 2012 (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.
The purpose of this study was to determine the effect of soluble corn fiber on calcium absorption and retention and gut microflora in adolescent boys and girls.
Detailed description
In a previous study, soluble corn fiber (SCF) was found to greatly enhance calcium utilization and bone properties in a growing rat model. Because factors that enhance bone density and mineral content can potentially result in a skeleton that will resist fracture later in life, it is important to investigate this potential in adolescents. Therefore, the objective of this study was to determine the effect of SCF on calcium absorption and retention in adolescent boys and girls. A second objective of this study was to assess whether additional dietary fiber leads to changes in gut microflora which may influence calcium absorption. During this two-phase metabolic camp participants consumed packages of fruit snacks supplemented with either 0 or 6 grams of soluble corn fiber twice a day during the first phase of the study, and switch to the opposite treatment during the second phase, with a 2-week washout period in between. Subjects collected all excreta during both phases and calcium absorption, gut microbiota, height, weight, and bone density were evaluated throughout the 6-week period of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Soluble Corn Fiber | Placebo comparator | Dietary Supplement: No soluble corn fiberEach teen will receive a package of fruit snacks containing 0 g soluble corn fiber two times daily. |
| 12 g Soluble Corn Fiber | Active comparator | Dietary Supplement: 12 g soluble corn fiberEach teen will receive a package of fruit snacks containing 6 g soluble corn fiber two times daily |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Normal, healthy, white adolescents (Hispanic or non-Hispanic)
- Boys age 13-15
- Girls age 12-14
Key exclusion criteria (9 listed)
- Abnormal kidney or liver function
- Malabsorptive disorders
- Anemia
- Smoking
- History of medications that affect calcium metabolism
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 |
|---|---|---|
| No soluble corn fiberAlso: soluble corn fiberEach teen will receive a package of fruit snacks containing 0 g soluble corn fiber two times per day | Dietary supplement | No Soluble Corn Fiber |
| 12 g soluble corn fiberAlso: soluble corn fiberEach teen will receive a package of fruit snacks containing 6 g soluble corn fiber two times per day. | Dietary supplement | 12 g Soluble Corn Fiber |
Primary outcome
Calcium absorption and retention
Time frame: up to three weeks
Gut microbial profile
Time frame: up to three weeks
1 secondary outcome
Bone mineral content and density
Time frame: up to three weeks
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 10 Feb 2014.
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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.
Berdine Martin, PhD study director
Purdue University
Connie Weaver, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No soluble corn fiber and 12 g soluble corn fiber 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 9 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 10 Feb 2014. 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.
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?
Calcium absorption and retention (time frame: up to three weeks). The study lists 2 primary outcomes in all. 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 10 Feb 2014.