OsteoporosisMedSDNCT01653275
Mediterranean Diet for Post-menopausal Women: Effects on Bone Turnover
A study testing Mediterranean Diet in people with Osteoporosis and Postmenopausal Bone Loss, run by UConn Health at 1 site in United States.
Trial summary
The investigators propose a 24 week clinical research trial (12 week observational period followed by 12 week MedSD intervention) with feasibility of diet adoption and markers of bone turnover as the primary outcomes. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal Bone Loss
- What is being tested?
- Mediterranean Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 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 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- postmenopausal women > 65 years
- BMI<30 kg/m2
- able to travel to clinical sites for follow-up visits
- willing to make no changes to habitual physical activity or calcium and vitamin D intake for the study duration
Who cannot join
- any disease that may affect bone metabolism, (i.e Paget's disease, primary hyperparathyroidism)
- cancers of any kind (except basal or squamous cell of skin) in past 5 years
- use of medication known to affect bone metabolism
- extreme dietary behaviors or supplementation in excess of DRI upper limits
- following a medically prescribed diet or dietary pattern similar to the MedSD
- history of chronic renal or liver disease
- history of hip fracture or known vertebral fracture within the past year
- persons with an allergy to fish or nuts.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators propose a 24 week clinical research trial (12 week observational period followed by 12 week MedSD intervention) with feasibility of diet adoption and markers of bone turnover as the primary outcomes.
Read the detailed description
Postmenopausal women are at increased risk of osteoporosis and fracture. Components of a Mediterranean style diet (MedSD) are associated with reduced bone loss and fracture risk; however, the MedSD has not been tested in this population in the U.S. Therefore, fhe investigators propose a 24 week clinical research trial (12 week observational period followed by 12 week MedSD intervention) with feasibility of diet adoption and markers of bone turnover as the primary outcomes. The 12 week intervention will include provision of olive oil, walnuts and high n-3 polyunsaturated fatty acids (PUFA) fish to replace other fats and oils, processed snacks and red meat, respectively; accompanied with fruit, vegetable, whole grain and legumes intake recommendations. The investigators hypothesize the MedSD intervention will increase serum n-3 PUFA and decrease saturated fatty acids and n-6 PUFA and this will result in an improvement in bone turnover markers. The outcomes of the proposed intervention trial will promote further study of the benefits of a MedSD in the US. the investigators envision the research team to expand to other systems such as cardiovascular, metabolic, and inflammatory mechanisms in which less risk of disease is associated with a MedSD.
- Conditions
- Osteoporosis, Postmenopausal Bone Loss
- Being tested
- Mediterranean Diet
- Keywords
- Mediterranean Diet, Bone turnover, postmenopausal women
- Medical subject headings
- Osteoporosis, Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean DietOther
Subjects will receive key foods (olive oil, walnuts, frozen portions of high n-3 LCPUFA fish) and instructed in the quantity to consume each week. Olive oil : minimum of 3 tablespoons per day. Walnuts:10.5 oz/week (1.5 oz/day). High n-3 LCPUFA fish: 3 or more fish meals per week. Additional guidelines for altering diet include incorporation of fruits, vegetables, legumes, and whole grains to replace sweets, white bread and starches, red meat and highly processed foods.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet | Experimental | Subjects will receive key foods (olive oil, walnuts, frozen portions of high n-3 LCPUFA fish) and instructed in the quantity to consume each week. Olive oil : minimum of 3 tablespoons per day. Walnuts:10.5 oz/week (1.5 oz/day). High n-3 LCPUFA fish: 3 or more fish meals per week. Additional guidelines for altering diet include incorporation of fruits, vegetables, legumes, and whole grains to replace sweets, white bread and starches, red meat and highly processed foods. Receives: Other: Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
study adherence
Determine the extent to which postmenopausal women in the US can adhere to the MedSD intervention.
Measured: 8 months
Secondary outcomes (1)
Bone turnover markers
Determine if adherence to the MedSD will result in a reduction in bone resorption markers and enhance formation markers
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2014
- Study completionDec 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Connecticut
- Responsible party
- Principal investigator, Anne Kenny, UConn Health
- Investigators
- Anne Kenny, MD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653275
- Sponsor's protocol ID
- 12-136S-1
- Acronym
- MedSD
- Status last verified
- May 2017
- First submitted
- 26 Jul 2012
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: only deidentified data will be available to share
Publications
Bihuniak JD, Ramos A, Huedo-Medina T, Hutchins-Wiese H, Kerstetter JE, Kenny AM. Adherence to a Mediterranean-Style Diet and Its Influence on Cardiovascular Risk Factors in Postmenopausal Women. J Acad Nutr Diet. 2016 Nov;116(11):1767-1775. doi: 10.1016/j.jand.2016.06.377. Epub 2016 Aug 25.
PubMed 27568885
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean Diet for Post-menopausal Women: Effects on Bone Turnover
- ClinicalTrials.gov ID
- NCT01653275
- Acronym / sponsor ID
- MedSD / 12-136S-1
- Conditions
- Osteoporosis, Postmenopausal Bone Loss
- Keywords
- Mediterranean Diet, Bone turnover, postmenopausal women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- University of Connecticut
- Study start
- Apr 2012 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Jul 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.
The investigators propose a 24 week clinical research trial (12 week observational period followed by 12 week MedSD intervention) with feasibility of diet adoption and markers of bone turnover as the primary outcomes.
Detailed description
Postmenopausal women are at increased risk of osteoporosis and fracture. Components of a Mediterranean style diet (MedSD) are associated with reduced bone loss and fracture risk; however, the MedSD has not been tested in this population in the U.S. Therefore, fhe investigators propose a 24 week clinical research trial (12 week observational period followed by 12 week MedSD intervention) with feasibility of diet adoption and markers of bone turnover as the primary outcomes. The 12 week intervention will include provision of olive oil, walnuts and high n-3 polyunsaturated fatty acids (PUFA) fish to replace other fats and oils, processed snacks and red meat, respectively; accompanied with fruit, vegetable, whole grain and legumes intake recommendations. The investigators hypothesize the MedSD intervention will increase serum n-3 PUFA and decrease saturated fatty acids and n-6 PUFA and this will result in an improvement in bone turnover markers. The outcomes of the proposed intervention trial will promote further study of the benefits of a MedSD in the US. the investigators envision the research team to expand to other systems such as cardiovascular, metabolic, and inflammatory mechanisms in which less risk of disease is associated with a MedSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet | Experimental | Other: Mediterranean DietSubjects will receive key foods (olive oil, walnuts, frozen portions of high n-3 LCPUFA fish) and instructed in the quantity to consume each week. Olive oil : minimum of 3 tablespoons per day. Walnuts:10.5 oz/week (1.5 oz/day). High n-3 LCPUFA fish: 3 or more fish meals per week. Additional guidelines for altering diet include incorporation of fruits, vegetables, legumes, and whole grains to replace sweets, white bread and starches, red meat and highly processed foods. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- postmenopausal women > 65 years
- BMI<30 kg/m2
- able to travel to clinical sites for follow-up visits
- willing to make no changes to habitual physical activity or calcium and vitamin D intake for the study duration
Key exclusion criteria (8 listed)
- any disease that may affect bone metabolism, (i.e Paget's disease, primary hyperparathyroidism)
- cancers of any kind (except basal or squamous cell of skin) in past 5 years
- use of medication known to affect bone metabolism
- extreme dietary behaviors or supplementation in excess of DRI upper limits
- following a medically prescribed diet or dietary pattern similar to the MedSD
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 |
|---|---|---|
| Mediterranean DietSubjects will receive key foods (olive oil, walnuts, frozen portions of high n-3 LCPUFA fish) and instructed in the quantity to consume each week. Olive oil : minimum of 3 tablespoons per day. Walnuts:10.5 oz/week (1.5 oz/day). High n-3 LCPUFA fish: 3 or more fish meals per week. Additional guidelines for altering diet include incorporation of fruits, vegetables, legumes, and whole grains to replace sweets, white bread and starches, red meat and highly processed foods. | Other | Mediterranean Diet |
Primary outcome
study adherence
Time frame: 8 months
Determine the extent to which postmenopausal women in the US can adhere to the MedSD intervention.
1 secondary outcome
Bone turnover markers
Time frame: 8 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 10 May 2017.
- Results publication: PubMed 27568885Bihuniak JD, Ramos A, Huedo-Medina T, Hutchins-Wiese H, Kerstetter JE, Kenny AM. Adherence to a Mediterranean-Style Diet and Its Influence on Cardiovascular Risk Factors in Postmenopausal Women. J Acad Nutr Diet. 2016 Nov;116(11):1767-1775. doi: 10.1016/j.jand.2016.06.377. Epub 2016 Aug 25.
- Individual participant dataSharing planned: Undecided. only deidentified data will be available to share
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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.
Anne Kenny, MD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet in people with Osteoporosis and Postmenopausal Bone Loss, run by UConn Health 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 4 inclusion and 8 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 10 May 2017. 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. 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?
study adherence (time frame: 8 months). 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 NCT01653275, 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 10 May 2017.