Osteoporosis, PostmenopausalNCT02416947
Soluble Corn Fiber Effect on Bone Resorption in Post Menopausal Women
A study testing 0 g SCF, 10g SCF and 20g SCF in people with Osteoporosis, Postmenopausal, run by Purdue University.
Trial summary
This study is designed to study the dose response effect of continuous Soluble Corn Fiber (SCF) intake over a 50 day period on bone resorption in healthy post menopausal women using the 41Calcium methodology. To further understand the dose response effect of SCF bone biomarkers will be studied. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- 0 g SCF, 10g SCF and 20g SCF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Jan 2015
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women at least 4 years Postmenopausal
Who cannot join
- Medications affecting bone resorption
About this study
Official title: The Effect of Soluble Corn Fiber (SCF) on Bone Resorption in Post-Menopausal Women Using 41Calcium Technology
This study is designed to study the dose response effect of continuous Soluble Corn Fiber (SCF) intake over a 50 day period on bone resorption in healthy post menopausal women using the 41Calcium methodology. To further understand the dose response effect of SCF bone biomarkers will be studied.
Our hypothesis is that soluble corn fiber will reduce bone resorption in a dose dependent manner in comparison to placebo when estimated by urinary 41Calcium excretion as well as bone biomarkers of resorption.
Read the detailed description
Subjects will be dosed with 41Calcium , a long-lived radio isotope, which will become deposited in the skeleton after about 100 days. During this time subjects will collect 24 h urine monthly to monitor the decrease in 41Calcium urinary excretion. Subsequently, the baseline level of 41Calcium urinary excretion will be evaluated over a 50 day baseline period with 24 h urine collections every 10 days. Participants will then be randomized to one of three doses of soluble corn fiber (0,10,20 g/d) to be consumed in two equivalent doses per day for 50 days. Women will collect 24 h urine every 10 days. Each 50 day period will be followed by a 50 day washout period during which the subjects will continue to collect urine every 10 days.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- 0 g SCF, 10g SCF, 20g SCF
- Keywords
- Soluble Corn Fiber, Osteoporosis, Bone Loss
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0 g SCFDietary supplement
Also called 0 g Soluble Corn Fiber
0 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.
10g SCFDietary supplement
Also called 10 g Soluble Corn Fiber
10 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.
20g SCFDietary supplement
Also called 20 g Soluble Corn Fiber
20 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.
| Study group | Role | What they receive |
|---|---|---|
| 0g SCF | Placebo comparator | Subjects will consume 0 g of SCF in two equal doses as a muffin and a drink, daily for 50 days. Receives: Dietary Supplement: 0 g SCF |
| 10 g SCF | Active comparator | Subjects will consume 10 g of SCF in two equal doses as a muffin and a drink, daily for 50 days. Receives: Dietary Supplement: 10g SCF |
| 20g SCF | Active comparator | Subjects will consume 20 g of SCF in two equal doses as a muffin and a drink, daily for 50 days. Receives: Dietary Supplement: 20g SCF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 41Ca/Ca ratio in five 24 h urine collections during intervention periods compared to urinary 41Ca/Ca ratios during non-intervention periods
41Ca/Ca ratio will be determined by Accelerator Mass Spectrometry. A linear regression model including the data from the non-intervention ratios will determine the predicted 41Ca/Ca ratios over the course of the 350 day study. The percent change of 41Ca/Ca ratios in the 50 day intervention periods from the predicted values will determine the effect of the intervention.
Measured: 24 h urine collections on days 10, 20, 30, 40, and 50 of each of three intervention periods and 4 non intervention periods
Secondary outcomes (3)
Fasting serum bone specific alkaline phosphatase (BSAP), a biochemical bone formation marker
Measured: Fasting serum drawn at the end of each 50 day intervention period
Fasting serum osteocalcin (OC), a biochemical bone turnover marker
Measured: Fasting serum drawn at the end of each 50 day intervention period
Fasting urine N-terminal telopeptide, a biochemical bone resorption marker
Measured: Fasting urine collected at the end of each 50 day intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startMar 2012
- Primary completionJan 2015
- Study completionJan 2015
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 Osteoporosis, PostmenopausalStudies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Tate & Lyle Health & Nutrition Sciences
- Responsible party
- Principal investigator, Berdine Martin, Purdue University
- Investigators
- Connie M Weaver, Ph.D, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416947
- Sponsor's protocol ID
- TateLyle Ca41
- Status last verified
- Apr 2015
- First submitted
- 8 Apr 2015
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Jakeman SA, Henry CN, Martin BR, McCabe GP, McCabe LD, Jackson GS, Peacock M, Weaver CM. Soluble corn fiber increases bone calcium retention in postmenopausal women in a dose-dependent manner: a randomized crossover trial. Am J Clin Nutr. 2016 Sep;104(3):837-43. doi: 10.3945/ajcn.116.132761. Epub 2016 Jul 27.
PubMed 27465372
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Soluble Corn Fiber (SCF) on Bone Resorption in Post-Menopausal Women Using 41Calcium Technology
- ClinicalTrials.gov ID
- NCT02416947
- Acronym / sponsor ID
- TateLyle Ca41
- Conditions
- Osteoporosis, Postmenopausal
- Keywords
- Soluble Corn Fiber, Osteoporosis, Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Tate & Lyle Health & Nutrition Sciences
- Study start
- Mar 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Apr 2015 (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.
This study is designed to study the dose response effect of continuous Soluble Corn Fiber (SCF) intake over a 50 day period on bone resorption in healthy post menopausal women using the 41Calcium methodology. To further understand the dose response effect of SCF bone biomarkers will be studied.
Our hypothesis is that soluble corn fiber will reduce bone resorption in a dose dependent manner in comparison to placebo when estimated by urinary 41Calcium excretion as well as bone biomarkers of resorption.
Detailed description
Subjects will be dosed with 41Calcium , a long-lived radio isotope, which will become deposited in the skeleton after about 100 days. During this time subjects will collect 24 h urine monthly to monitor the decrease in 41Calcium urinary excretion. Subsequently, the baseline level of 41Calcium urinary excretion will be evaluated over a 50 day baseline period with 24 h urine collections every 10 days. Participants will then be randomized to one of three doses of soluble corn fiber (0,10,20 g/d) to be consumed in two equivalent doses per day for 50 days. Women will collect 24 h urine every 10 days. Each 50 day period will be followed by a 50 day washout period during which the subjects will continue to collect urine every 10 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0g SCF | Placebo comparator | Dietary Supplement: 0 g SCFSubjects will consume 0 g of SCF in two equal doses as a muffin and a drink, daily for 50 days. |
| 10 g SCF | Active comparator | Dietary Supplement: 10g SCFSubjects will consume 10 g of SCF in two equal doses as a muffin and a drink, daily for 50 days. |
| 20g SCF | Active comparator | Dietary Supplement: 20g SCFSubjects will consume 20 g of SCF in two equal doses as a muffin and a drink, daily for 50 days. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women at least 4 years Postmenopausal
Key exclusion criteria (1 listed)
- Medications affecting bone resorption
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 g SCFAlso: 0 g Soluble Corn Fiber0 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink. | Dietary supplement | 0g SCF |
| 10g SCFAlso: 10 g Soluble Corn Fiber10 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink. | Dietary supplement | 10 g SCF |
| 20g SCFAlso: 20 g Soluble Corn Fiber20 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink. | Dietary supplement | 20g SCF |
Primary outcome
Change in 41Ca/Ca ratio in five 24 h urine collections during intervention periods compared to urinary 41Ca/Ca ratios during non-intervention periods
Time frame: 24 h urine collections on days 10, 20, 30, 40, and 50 of each of three intervention periods and 4 non intervention periods
41Ca/Ca ratio will be determined by Accelerator Mass Spectrometry. A linear regression model including the data from the non-intervention ratios will determine the predicted 41Ca/Ca ratios over the course of the 350 day study. The percent change of 41Ca/Ca ratios in the 50 day intervention periods from the predicted values will determine the effect of the intervention.
3 secondary outcomes
Fasting serum bone specific alkaline phosphatase (BSAP), a biochemical bone formation marker
Time frame: Fasting serum drawn at the end of each 50 day intervention period
Fasting serum osteocalcin (OC), a biochemical bone turnover marker
Time frame: Fasting serum drawn at the end of each 50 day intervention period
Fasting urine N-terminal telopeptide, a biochemical bone resorption marker
Time frame: Fasting urine collected at the end of each 50 day intervention period
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 15 Apr 2015.
- Derived from this study: PubMed 27465372Jakeman SA, Henry CN, Martin BR, McCabe GP, McCabe LD, Jackson GS, Peacock M, Weaver CM. Soluble corn fiber increases bone calcium retention in postmenopausal women in a dose-dependent manner: a randomized crossover trial. Am J Clin Nutr. 2016 Sep;104(3):837-43. doi: 10.3945/ajcn.116.132761. Epub 2016 Jul 27.
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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
Questions about this trial
What is this clinical trial studying?
A study testing 0 g SCF, 10g SCF and 20g SCF in people with Osteoporosis, Postmenopausal, run by Purdue University.
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 1 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 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in 41Ca/Ca ratio in five 24 h urine collections during intervention periods compared to urinary 41Ca/Ca ratios during non-intervention periods (time frame: 24 h urine collections on days 10, 20, 30, 40, and 50 of each of three intervention periods and 4 non intervention periods). 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 NCT02416947, 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 15 Apr 2015.