OsteopeniaPolivD3NCT01828944
Olive Oil Polyphenols, Vitamin D, Docosahexaenoic Acid (DHA) and Locomotor Function (PolivD3)
A study testing olive oil in people with Osteopenia and Sarcopenia, run by Lesieur at 2 sites in France.
Trial summary
The present project hypothesizes that the potential protective effect of olive oil relies on its polyphenols profile (quality and quantity) and that it may be synergistic to other food components. Read more about this study
- Who is it for?
- Ages 57 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteopenia, Sarcopenia
- What is being tested?
- olive oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2012to Apr 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 57 to 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasian female
- Within at least 7 years post-menopause
- Generally healthy as determined by standard medical assessment on physical and mental health
- Normal weight as determined by BMI (20≤ BMI ≤30)
- Affiliated to National Health Insurance
- Willing to comply with the study procedures
Show all 9Show fewer
- 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, malignancy, chronic malnutrition
- Osteoporosis (defined by T-score of -2.5 standard deviation (SD) at hip and/or spine)
- On therapy with drugs known to interfere with bone and muscle metabolism
- Taking regular calcium and vitamin D supplements
- Currently participating or having participated in another clinical trial during past 1 year prior to the beginning of this study, this depending on the type of previous study•
- Intense Physical activity
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre de Recherche en Nutrition Humaine
Clermont-Ferrand, Auvergne, 63000
Centre d'investigation clinique
Marseille, Bouche Du Rhône, 13005
About this study
Official title: Olive Oil Polyphenols, Vitamin D and Docosahexaenoic Acid (DHA) Synergistic Effects on Locomotor Function
The present project hypothesizes that the potential protective effect of olive oil relies on its polyphenols profile (quality and quantity) and that it may be synergistic to other food components. Among the nutrients that may be of interest for bone and muscle tissues, unsaturated fatty acids and vitamins are the most described.
Consequently, based on the promising available preliminary data, the present project aims to investigate the possible preventive effect of olive oil polyphenols and eventually the synergistic effects of fatty acids and vitamin D on bone, muscle and adipose tissue, in order to prevent any locomotor dysfunction.
Volunteers will be supplemented during 9 months. The primary and secondary outcome measures will be performed at baseline, 3 and 9 months.
- Conditions
- Osteopenia, Sarcopenia
- Being tested
- olive oil
- Keywords
- Vitamin D, bone loss
- Medical subject headings
- Bone Diseases, Metabolic, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olive oilDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Extra virgin olive oil | Active comparator | Extra virgin olive oil Receives: Dietary Supplement: olive oil |
| Enriched extra virgin olive oil | Experimental | Enriched extra virgin olive oil Receives: Dietary Supplement: olive oil |
| refined olive oil | Placebo comparator | refined olive oil Receives: Dietary Supplement: olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bone mineral density
Measured: at baseline and after 9 months of supplementation
Secondary outcomes (2)
Changes in serum markers of bone resorption
Measured: At baseline, 3 and 9 months
changes in serum markers of bone formation
Measured: At baseline, 3 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startDec 2012
- Primary completionApr 2015
- Study completionApr 2015
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.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lesieur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Centre de Recherche en Nutrition Humaine d'Auvergne
- Responsible party
- Sponsor
- Investigators
- Véronique Coxam, PhD, Study director, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828944
- Sponsor's protocol ID
- AU961
- Other IDs
- 2012-A00344-39 [N°IDRCB]
- Acronym
- PolivD3
- Status last verified
- Jan 2015
- First submitted
- 2 Apr 2013
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olive Oil Polyphenols, Vitamin D and Docosahexaenoic Acid (DHA) Synergistic Effects on Locomotor Function
- ClinicalTrials.gov ID
- NCT01828944
- Acronym / sponsor ID
- PolivD3 / AU961
- Conditions
- Osteopenia, Sarcopenia
- Keywords
- Vitamin D, bone loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- LesieurIndustry (pharma, biotech, devices)
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Centre de Recherche en Nutrition Humaine d'Auvergne
- Study start
- Dec 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 11 Apr 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 present project hypothesizes that the potential protective effect of olive oil relies on its polyphenols profile (quality and quantity) and that it may be synergistic to other food components. Among the nutrients that may be of interest for bone and muscle tissues, unsaturated fatty acids and vitamins are the most described.
Consequently, based on the promising available preliminary data, the present project aims to investigate the possible preventive effect of olive oil polyphenols and eventually the synergistic effects of fatty acids and vitamin D on bone, muscle and adipose tissue, in order to prevent any locomotor dysfunction.
Volunteers will be supplemented during 9 months. The primary and secondary outcome measures will be performed at baseline, 3 and 9 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Extra virgin olive oil | Active comparator | Dietary Supplement: olive oilExtra virgin olive oil |
| Enriched extra virgin olive oil | Experimental | Dietary Supplement: olive oilEnriched extra virgin olive oil |
| refined olive oil | Placebo comparator | Dietary Supplement: olive oilrefined olive oil |
Who may qualify
- Ages
- 57 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Caucasian female
- Within at least 7 years post-menopause
- Generally healthy as determined by standard medical assessment on physical and mental health
- Normal weight as determined by BMI (20≤ BMI ≤30)
- Affiliated to National Health Insurance
Key exclusion criteria (6 listed)
- Intestinal or severe metabolic diseases / disorders such as diabetes, renal, hepatic or pancreatic diseases / disorders, ulcer, hyperthyroidism, malignancy, chronic malnutrition
- Osteoporosis (defined by T-score of -2.5 standard deviation (SD) at hip and/or spine)
- On therapy with drugs known to interfere with bone and muscle metabolism
- Taking regular calcium and vitamin D supplements
- Currently participating or having participated in another clinical trial during past 1 year prior to the beginning of this study, this depending on the type of previous 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 |
|---|---|---|
| olive oil | Dietary supplement | Enriched extra virgin olive oil, Extra virgin olive oil, refined olive oil |
Primary outcome
Changes in bone mineral density
Time frame: at baseline and after 9 months of supplementation
2 secondary outcomes
Changes in serum markers of bone resorption
Time frame: At baseline, 3 and 9 months
changes in serum markers of bone formation
Time frame: At baseline, 3 and 9 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 29 Apr 2015.
- Related InfoLink provided by the sponsor.
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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.
Véronique Coxam, PhD study director
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing olive oil in people with Osteopenia and Sarcopenia, run by Lesieur at 2 sites in France.
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 9 inclusion and 6 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 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Changes in bone mineral density (time frame: at baseline and after 9 months of supplementation). 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 29 Apr 2015.