Mediterranean Diet for Post-menopausal Women: Effects on Bone Turnover (MedSD)
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Purpose
We 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.
| Condition | Intervention |
|---|---|
|
Osteoporosis Postmenopausal Bone Loss |
Other: Mediterranean Diet |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Mediterranean Diet for Post-menopausal Women: Effects on Bone Turnover |
- study adherence [ Time Frame: 8 months ] [ Designated as safety issue: No ]Determine the extent to which postmenopausal women in the US can adhere to the MedSD intervention.
- Bone turnover markers [ Time Frame: 8 months ] [ Designated as safety issue: No ]Determine if adherence to the MedSD will result in a reduction in bone resorption markers and enhance formation markers
| Estimated Enrollment: | 20 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Mediterranean Diet
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.
|
Other: Mediterranean Diet
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.
|
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, we 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. We 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. We 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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- postmenopausal women > 65 years; 2) BMI<30 kg/m2; 3) able to travel to clinical sites for follow-up visits; 4) willing to make no changes to habitual physical activity or calcium and vitamin D intake for the study duration
Exclusion Criteria:
- 1) any disease that may affect bone metabolism, (i.e Paget's disease, primary hyperparathyroidism); 2) cancers of any kind (except basal or squamous cell of skin) in past 5 years; 3) use of medication known to affect bone metabolism; 6) extreme dietary behaviors or supplementation in excess of DRI upper limits; 7) following a medically prescribed diet or dietary pattern similar to the MedSD; 9) history of chronic renal or liver disease; 10) history of hip fracture or known vertebral fracture within the past year; 11) persons with an allergy to fish or nuts.
Contacts and Locations| Contact: Nancy Dean | 860-679-8865 | NDEAN@NSO1.UCHC.EDU |
| Contact: Anne Kenny | 860-679-8865 | kenny@uchc.edu |
| United States, Connecticut | |
| UCHC | Recruiting |
| Farmington, Connecticut, United States, 06030 | |
| Contact: Dean 860-679-8865 | |
| Principal Investigator: Anne Kenny, MD | |
| Principal Investigator: | Anne Kenny, MD | University of Connecticut Health Center |
More Information
No publications provided
| Responsible Party: | Anne Kenny, Professor of Medicine, University of Connecticut Health Center |
| ClinicalTrials.gov Identifier: | NCT01653275 History of Changes |
| Other Study ID Numbers: | 12-136S-1 |
| Study First Received: | July 26, 2012 |
| Last Updated: | July 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Connecticut Health Center:
|
Mediterranean Diet Bone turnover postmenopausal women |
Additional relevant MeSH terms:
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013