Osteoporosis, PostmenopausalHesperidinNCT01881204
Hesperidin and Bone Health in Postmenopausal Women
A study testing Hesperidin and Calcilock and Hesperidin in people with Osteoporosis, Postmenopausal, run by Purdue University at 1 site in United States.
Trial summary
The primary objective of this clinical trial is to test hesperidin with and without CALCILOCK® for bone resorption suppressing effect in postmenopausal women. The secondary objective is the comparison between 41Ca technology and classical biomarker to evaluate bone resorption. 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?
- Hesperidin and Calcilock and Hesperidin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Oct 2012
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this clinical trial is to test hesperidin with and without CALCILOCK® for bone resorption suppressing effect in postmenopausal women. The secondary objective is the comparison between 41Ca technology and classical biomarker to evaluate bone resorption.
Read the detailed description
Subjects will participate in four phases of the study: Baseline of 50 days and three intervention phases which include 50 days receiving product followed by 50 days of recovery. The total duration of the study will be 350 days. If participant has not been previously labeled with 41Ca, a 150 day period is added to the study.
Hesperidin (552mg) and Calcilock® (amount per day: Calcium: 684 mg; Phosphorus: 282mg; Magnesium: 102mg; Zinc: 2.86mg; Vitamin C: 20 mg; Vitamin K1: 28µg; Vitamin D: 1.86µg) will be administered in the form of cookies (biscuit).
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- Hesperidin and Calcilock, Hesperidin, Control
- Keywords
- Hesperidin, 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.
Hesperidin and CalcilockDietary supplement
Hesperidin (552mg) and Calcilock® (amount per day: Calcium: 684 mg; Phosphorus: 282mg; Magnesium: 102mg; Zinc: 2.86mg; Vitamin C: 20 mg; Vitamin K1: 28µg; Vitamin D: 1.86µg) will be administered in the form of cookies (biscuit).
HesperidinDietary supplement
Hesperidin (552mg) will be administered in the form of cookies (biscuit).
ControlDietary supplement
Cookies without Hesperidin or Calcilock added.
| Study group | Role | What they receive |
|---|---|---|
| Hesperidin and Calcilock | Experimental | Subjects will consume 4 cookies containing Hesperidin and Calcilock. Receives: Dietary Supplement: Hesperidin and Calcilock |
| Hesperidin | Experimental | Subjects will consume 4 cookies containing Hesperidin, 552mg, daily Receives: Dietary Supplement: Hesperidin |
| Control | Placebo comparator | Subjects will consume 4 cookies daily without Hesperidin or Calcilock. Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elimination of 41Calcium in Urine.
Appearance of Ca41 in urine will be measured by Accelerator Mass Spectrometry to represent calcium that is being lost from the skeleton.
Measured: 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startApr 2011
- Primary completionOct 2012
- Study completionOct 2012
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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Nestec Ltd.
- 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
- NCT01881204
- Sponsor's protocol ID
- 10.21.NRC
- Acronym
- Hesperidin
- Status last verified
- May 2018
- First submitted
- 17 Jun 2013
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Martin BR, McCabe GP, McCabe L, Jackson GS, Horcajada MN, Offord-Cavin E, Peacock M, Weaver CM. Effect of Hesperidin With and Without a Calcium (Calcilock) Supplement on Bone Health in Postmenopausal Women. J Clin Endocrinol Metab. 2016 Mar;101(3):923-7. doi: 10.1210/jc.2015-3767. Epub 2016 Jan 11.
PubMed 26751193
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hesperidin and Bone Health in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01881204
- Acronym / sponsor ID
- Hesperidin / 10.21.NRC
- Conditions
- Osteoporosis, Postmenopausal
- Keywords
- Hesperidin, Osteoporosis, Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Nestec Ltd.
- Study start
- Apr 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 19 Jun 2013 (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 primary objective of this clinical trial is to test hesperidin with and without CALCILOCK® for bone resorption suppressing effect in postmenopausal women. The secondary objective is the comparison between 41Ca technology and classical biomarker to evaluate bone resorption.
Detailed description
Subjects will participate in four phases of the study: Baseline of 50 days and three intervention phases which include 50 days receiving product followed by 50 days of recovery. The total duration of the study will be 350 days. If participant has not been previously labeled with 41Ca, a 150 day period is added to the study.
Hesperidin (552mg) and Calcilock® (amount per day: Calcium: 684 mg; Phosphorus: 282mg; Magnesium: 102mg; Zinc: 2.86mg; Vitamin C: 20 mg; Vitamin K1: 28µg; Vitamin D: 1.86µg) will be administered in the form of cookies (biscuit).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hesperidin and Calcilock | Experimental | Dietary Supplement: Hesperidin and CalcilockSubjects will consume 4 cookies containing Hesperidin and Calcilock. |
| Hesperidin | Experimental | Dietary Supplement: HesperidinSubjects will consume 4 cookies containing Hesperidin, 552mg, daily |
| Control | Placebo comparator | Dietary Supplement: ControlSubjects will consume 4 cookies daily without Hesperidin or Calcilock. |
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 |
|---|---|---|
| Hesperidin and CalcilockHesperidin (552mg) and Calcilock® (amount per day: Calcium: 684 mg; Phosphorus: 282mg; Magnesium: 102mg; Zinc: 2.86mg; Vitamin C: 20 mg; Vitamin K1: 28µg; Vitamin D: 1.86µg) will be administered in the form of cookies (biscuit). | Dietary supplement | Hesperidin and Calcilock |
| HesperidinHesperidin (552mg) will be administered in the form of cookies (biscuit). | Dietary supplement | Hesperidin |
| ControlCookies without Hesperidin or Calcilock added. | Dietary supplement | Control |
Primary outcome
Elimination of 41Calcium in Urine.
Time frame: 50 days
Appearance of Ca41 in urine will be measured by Accelerator Mass Spectrometry to represent calcium that is being lost from the skeleton.
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 17 May 2018.
- Derived from this study: PubMed 26751193Martin BR, McCabe GP, McCabe L, Jackson GS, Horcajada MN, Offord-Cavin E, Peacock M, Weaver CM. Effect of Hesperidin With and Without a Calcium (Calcilock) Supplement on Bone Health in Postmenopausal Women. J Clin Endocrinol Metab. 2016 Mar;101(3):923-7. doi: 10.1210/jc.2015-3767. Epub 2016 Jan 11.
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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 Hesperidin and Calcilock and Hesperidin in people with Osteoporosis, Postmenopausal, 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 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 17 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?
Elimination of 41Calcium in Urine. (time frame: 50 days). 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 NCT01881204, 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 17 May 2018.