OsteoporosisNCT01660503
Dose Effects of SCF on Calcium Metabolism and GI Microflora in Adolescents
A study testing 0 grams SCF, 10 grams SCF and 20 grams SCF in people with Osteoporosis, run by Purdue University at 1 site in United States.
Trial summary
Soluble corn fiber (SCF) has been shown to enhance calcium utilization and bone properties in rats and in adolescent boys and girls. Read more about this study
- Who is it for?
- Ages 9 to 13 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- 0 grams SCF, 10 grams SCF and 20 grams SCF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2012to 30 Apr 2014
- 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 9 to 13 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy adolescent Caucasian girls between the ages of 12-14. This population has been chosen because they exhibit higher risk for osteoporosis later in life.
Who cannot join
- Habitual dietary patterns including less than 550 and greater than 1500 mg Ca per day. This represents the 5th and 95th percentile of usual intake of girls 9-13 y in the US.
- History of smoking, alcohol use, illegal or non-prescription drug use
- History of disordered calcium or bone metabolism e.g. Paget's disease, hyper or hypo-calcemia
- History of gastrointestinal diseases (Crohn's, celiac, inflammatory bowel disease)
- History of diseases that affect kidney or liver function.
- Body Mass Index (BMI) less than 5th percentile for age or greater than the 90th percentile for age
Show all 9Show fewer
- Having a broken bone within the last 6 months.
- Regular consumption of foods or supplements containing prebiotics or probiotics
- History of pregnancy or use of contraceptives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Response Effects of Soluble Corn Fiber (SCF) on Calcium Metabolism and Gastrointestinal Microflora in Adolescents
Soluble corn fiber (SCF) has been shown to enhance calcium utilization and bone properties in rats and in adolescent boys and girls.
Read the detailed description
The growing knowledge of non-digestible oligosaccharide (NDO)-related health benefits has led to the identification of other fermentable carbohydrates which may improve bone balance and bone health parameters. One such carbohydrate is the corn derivative, soluble corn fiber (SCF). Already known for its association with improved intestinal health and influence on colonic microflora content, we have been studying the effects of SCF on calcium absorption and bone health. First we found that soluble corn fiber (SCF) greatly enhanced calcium utilization and bone properties in a growing rat model. Results from this study demonstrated that SCF was capable of increasing bone mineral content, density and bone strength parameters in 4-week old, male rats. Our study in adolescent boys and girls showed a 12% increase in calcium absorption after consuming 12 g SCF for 21 days compared to a control period in a crossover design using a controlled feeding metabolic balance approach. Given these profound changes on calcium absorption and in bone, a logical next step is to study a dose-response effect of SCF on calcium absorption, bone turnover, and gut microflora in free-living adolescents.
- Conditions
- Osteoporosis
- Being tested
- 0 grams SCF, 10 grams SCF, 20 grams SCF
- Keywords
- Calcium absorption, Osteoporosis, Bone Health, Adolescent
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0 grams SCFDietary supplement
Given in snack foods (muffins and flavored beverage)
10 grams SCFDietary supplement
Given in snack foods (muffins and flavored beverage)
20 grams SCFDietary supplement
Given in snack foods (muffins and flavored beverage)
| Study group | Role | What they receive |
|---|---|---|
| No SCF | Placebo comparator | Twice daily consumption of snack foods containing no SCF. Receives: Dietary Supplement: 0 grams SCF |
| 10 grams SCF | Experimental | Twice daily consumption of snack foods, each containing 5 grams SCF Receives: Dietary Supplement: 10 grams SCF |
| 20 grams SCF | Experimental | Twice daily consumption of snack foods, each containing 10 grams SCF Receives: Dietary Supplement: 20 grams SCF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium Absorption
The subject will be asked to consume one snack item in the morning and one snack in the evening for four consecutive weeks.
After consuming the SCF product for four weeks the teen will come to Purdue University campus for 3 nights and days (e.g. Thursday noon - Sunday noon). They will reside in university residence hall or hotel near campus. Calcium Absorption testing will be done utilizing 43Ca and 44Ca.
Measured: 4 Weeks
Secondary outcomes (1)
GI microbial changes
Fecal microbial analyses will be performed on a baseline sample collected before each 4 week consumption period to establish basal microbial profiles. Additional analyses will be performed on fecal samples collected during the 3 day clinical visit to compare microbial changes in response to SCF treatments.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study start1 Jun 2012
- Primary completion30 Apr 2014
- Study completion30 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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
- Connie M Weaver, Ph.D., Principal investigator, Purdue UniversityBerdine R Martin, PhD, Study director, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660503
- Sponsor's protocol ID
- Tate & Lyle Teen Study
- Status last verified
- May 2018
- First submitted
- 6 Aug 2012
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Whisner CM, Martin BR, Nakatsu CH, Story JA, MacDonald-Clarke CJ, McCabe LD, McCabe GP, Weaver CM. Soluble Corn Fiber Increases Calcium Absorption Associated with Shifts in the Gut Microbiome: A Randomized Dose-Response Trial in Free-Living Pubertal Females. J Nutr. 2016 Jul;146(7):1298-306. doi: 10.3945/jn.115.227256. Epub 2016 Jun 8.
PubMed 27281813
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response Effects of Soluble Corn Fiber (SCF) on Calcium Metabolism and Gastrointestinal Microflora in Adolescents
- ClinicalTrials.gov ID
- NCT01660503
- Acronym / sponsor ID
- Tate & Lyle Teen Study
- Conditions
- Osteoporosis
- Keywords
- Calcium absorption, Osteoporosis, Bone Health, Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Tate and Lyle Ingredients Americas LLC
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 30 Apr 2014 (actual)
- Study completion
- 30 Apr 2014 (actual)
- First posted
- 8 Aug 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.
Soluble corn fiber (SCF) has been shown to enhance calcium utilization and bone properties in rats and in adolescent boys and girls.
Detailed description
The growing knowledge of non-digestible oligosaccharide (NDO)-related health benefits has led to the identification of other fermentable carbohydrates which may improve bone balance and bone health parameters. One such carbohydrate is the corn derivative, soluble corn fiber (SCF). Already known for its association with improved intestinal health and influence on colonic microflora content, we have been studying the effects of SCF on calcium absorption and bone health. First we found that soluble corn fiber (SCF) greatly enhanced calcium utilization and bone properties in a growing rat model. Results from this study demonstrated that SCF was capable of increasing bone mineral content, density and bone strength parameters in 4-week old, male rats. Our study in adolescent boys and girls showed a 12% increase in calcium absorption after consuming 12 g SCF for 21 days compared to a control period in a crossover design using a controlled feeding metabolic balance approach. Given these profound changes on calcium absorption and in bone, a logical next step is to study a dose-response effect of SCF on calcium absorption, bone turnover, and gut microflora in free-living adolescents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No SCF | Placebo comparator | Dietary Supplement: 0 grams SCFTwice daily consumption of snack foods containing no SCF. |
| 10 grams SCF | Experimental | Dietary Supplement: 10 grams SCFTwice daily consumption of snack foods, each containing 5 grams SCF |
| 20 grams SCF | Experimental | Dietary Supplement: 20 grams SCFTwice daily consumption of snack foods, each containing 10 grams SCF |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy adolescent Caucasian girls between the ages of 12-14. This population has been chosen because they exhibit higher risk for osteoporosis later in life.
Key exclusion criteria (9 listed)
- Habitual dietary patterns including less than 550 and greater than 1500 mg Ca per day. This represents the 5th and 95th percentile of usual intake of girls 9-13 y in the US.
- History of smoking, alcohol use, illegal or non-prescription drug use
- History of disordered calcium or bone metabolism e.g. Paget's disease, hyper or hypo-calcemia
- History of gastrointestinal diseases (Crohn's, celiac, inflammatory bowel disease)
- History of diseases that affect kidney or liver function.
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 |
|---|---|---|
| 0 grams SCFGiven in snack foods (muffins and flavored beverage) | Dietary supplement | No SCF |
| 10 grams SCFGiven in snack foods (muffins and flavored beverage) | Dietary supplement | 10 grams SCF |
| 20 grams SCFGiven in snack foods (muffins and flavored beverage) | Dietary supplement | 20 grams SCF |
Primary outcome
Calcium Absorption
Time frame: 4 Weeks
The subject will be asked to consume one snack item in the morning and one snack in the evening for four consecutive weeks. After consuming the SCF product for four weeks the teen will come to Purdue University campus for 3 nights and days (e.g. Thursday noon - Sunday noon). They will reside in university residence hall or hotel near campus. Calcium Absorption testing will be done utilizing 43Ca and 44Ca.
1 secondary outcome
GI microbial changes
Time frame: 4 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 4 May 2018.
- Derived from this study: PubMed 27281813Whisner CM, Martin BR, Nakatsu CH, Story JA, MacDonald-Clarke CJ, McCabe LD, McCabe GP, Weaver CM. Soluble Corn Fiber Increases Calcium Absorption Associated with Shifts in the Gut Microbiome: A Randomized Dose-Response Trial in Free-Living Pubertal Females. J Nutr. 2016 Jul;146(7):1298-306. doi: 10.3945/jn.115.227256. Epub 2016 Jun 8.
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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, Ph.D. 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 study testing 0 grams SCF, 10 grams SCF and 20 grams SCF 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 1 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 4 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.
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 (time frame: 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01660503, which also lists 1 linked publication.
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 4 May 2018.