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| Name | Class |
|---|---|
| University of Connecticut | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean Diet | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| study adherence | Determine the extent to which postmenopausal women in the US can adhere to the MedSD intervention. | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bone turnover markers | Determine if adherence to the MedSD will result in a reduction in bone resorption markers and enhance formation markers | 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Kenny, MD | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCHC | Farmington | Connecticut | 06030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27568885 | Result | 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. |
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only deidentified data will be available to share
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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|
| D009750 |
| Nutritional and Metabolic Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |