OsteopeniaPhase 2NCT00545116
Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women
A Phase 2 study testing Hesperidin in people with Osteopenia and Osteoporosis, run by Société des Produits Nestlé (SPN) at 1 site in Malaysia.
Trial summary
The primary objective of this clinical trial is to determine the effects of hesperidin on biochemical markers of bone in post-menopausal women. The secondary objectives are: To investigate changes in bone formation and bone resorption markers in response to hesperidin intake To compare the efficacy of hesperidin in a… Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteopenia, Osteoporosis
- What is being tested?
- Hesperidin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteMalaysia
- Study dates
- Oct 2007to Jan 2012
- Phase
- Phase 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 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community dwelling women
- More than 4 years post-menopause (natural or surgical)
- Generally healthy as determined by standard medical assessment on physical and mental health
- Willing to comply with the study procedures
- Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data
- Having received both oral and written explanations about the study
- Having provided her written informed consent
Who cannot join
- Intestinal or severe metabolic diseases / disorders such as diabetes, renal, hepatic or pancreatic diseases / disorders, ulcer, hyperthyroidism, malignance, chronic malnutrition
- Have had major gastrointestinal surgery
- On therapy with drugs known to interfere with bone metabolism such as steroids, vitamin D or its derivatives, bisphosphonates, strontium ranelate, PTH, calcitonin, raloxifene, etc.
- Had sustained a fracture in the preceding 12 months
- On hormone replacement therapy (HRT) in the previous 3 months before entering the study
- Taking medications containing hesperidin (e.g.Daflon) or known to interfere with hesperidin (statins, therapy for circulatory disorders, anti-depressants)
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- Known to have allergic reactions to citrus-containing foods
- Baseline calcium intake less than 500 mg/day
- Have an alcohol intake > 2 glasses of wine per day (3dL/day), or > 2 beers (3dL/d) or > 1 shot glass of hard alcohol
- Heavy smoker (more than 10 cigs a day)
- Special dietary habits (vegetarians)
- Phytoestrogens or antioxidants (dietary supplements) consumption
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital of UKM, National University of Malaysia
Kuala Lumpur, 56000
About this study
Official title: Short-term Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women: a Randomized Placebo-controlled Trial
The primary objective of this clinical trial is to determine the effects of hesperidin on biochemical markers of bone in post-menopausal women.
The secondary objectives are:
- To investigate changes in bone formation and bone resorption markers in response to hesperidin intake
- To compare the efficacy of hesperidin in a milk versus biscuit
- To collect safety information of hesperidin consumption in a human trial
- Conditions
- Osteopenia, Osteoporosis
- Being tested
- Hesperidin
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HesperidinOther
250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months
| Study group | Role | What they receive |
|---|---|---|
| a | Experimental | Active carrier 1: biscuit providing 250 mg hesperidin per piece(6g) Receives: Other: Hesperidin |
| b | Experimental | Active carrier 2: liquid skim milk providing 250 mg hesperidin/serve (200 ml) and containing around 300 mg calcium/serving Receives: Other: Hesperidin |
| c | Placebo comparator | Placebo carrier 1: biscuit with the same nutrient composition and appearance as the active biscuit carrier but minus hesperidin Receives: Other: Hesperidin |
| d | Placebo comparator | Placebo carrier 2: liquid skim milk with the same nutrient composition and appearance as the active milk carrier but minus hesperidin Receives: Other: Hesperidin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline for bone formation (serum P1NP & osteocalcin) and bone resorption (urinary NTX & serum CTX) markers
Measured: Six months
Secondary outcomes (2)
Full blood biochemistry analyses including lipid profile
Measured: 6 months
Percentage change from baseline for osteoarthritis markers (CTX2 and others)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National University of Malaysia
- Responsible party
- Sponsor
- Investigators
- Winnie Chee, PhD, Principal investigator, Faculty of Allied Health Sciences, UKM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545116
- Sponsor's protocol ID
- Nestec 06.34
- Status last verified
- Jan 2014
- First submitted
- 16 Oct 2007
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women: a Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT00545116
- Acronym / sponsor ID
- Nestec 06.34
- Conditions
- Osteopenia, Osteoporosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- National University of Malaysia
- Study start
- Oct 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 17 Oct 2007 (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 determine the effects of hesperidin on biochemical markers of bone in post-menopausal women.
The secondary objectives are:
- To investigate changes in bone formation and bone resorption markers in response to hesperidin intake
- To compare the efficacy of hesperidin in a milk versus biscuit
- To collect safety information of hesperidin consumption in a human trial
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| a | Experimental | Other: HesperidinActive carrier 1: biscuit providing 250 mg hesperidin per piece(6g) |
| b | Experimental | Other: HesperidinActive carrier 2: liquid skim milk providing 250 mg hesperidin/serve (200 ml) and containing around 300 mg calcium/serving |
| c | Placebo comparator | Other: HesperidinPlacebo carrier 1: biscuit with the same nutrient composition and appearance as the active biscuit carrier but minus hesperidin |
| d | Placebo comparator | Other: HesperidinPlacebo carrier 2: liquid skim milk with the same nutrient composition and appearance as the active milk carrier but minus hesperidin |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Community dwelling women
- More than 4 years post-menopause (natural or surgical)
- Generally healthy as determined by standard medical assessment on physical and mental health
- Willing to comply with the study procedures
- Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data
Key exclusion criteria (12 listed)
- Intestinal or severe metabolic diseases / disorders such as diabetes, renal, hepatic or pancreatic diseases / disorders, ulcer, hyperthyroidism, malignance, chronic malnutrition
- Have had major gastrointestinal surgery
- On therapy with drugs known to interfere with bone metabolism such as steroids, vitamin D or its derivatives, bisphosphonates, strontium ranelate, PTH, calcitonin, raloxifene, etc.
- Had sustained a fracture in the preceding 12 months
- On hormone replacement therapy (HRT) in the previous 3 months before entering the study
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 |
|---|---|---|
| Hesperidin250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months | Other | a, b, c, d |
Primary outcome
Percentage change from baseline for bone formation (serum P1NP & osteocalcin) and bone resorption (urinary NTX & serum CTX) markers
Time frame: Six months
2 secondary outcomes
Full blood biochemistry analyses including lipid profile
Time frame: 6 months
Percentage change from baseline for osteoarthritis markers (CTX2 and others)
Time frame: 6 months
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 6 Oct 2015.
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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.
Winnie Chee, PhD principal investigator
Faculty of Allied Health Sciences, UKM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hesperidin in people with Osteopenia and Osteoporosis, run by Société des Produits Nestlé (SPN) at 1 site in Malaysia.
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 7 inclusion and 12 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 6 Oct 2015. 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 Malaysia. 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 phase mean?
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?
Percentage change from baseline for bone formation (serum P1NP & osteocalcin) and bone resorption (urinary NTX & serum CTX) markers (time frame: Six months). 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 6 Oct 2015.