View Clinical Trial (Medical Research Study)
Mediterranean Diet for Post-menopausal Women: Effects on Bone Turnover
| City: |
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Farmington |
| State: |
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Connecticut |
| Zip Code: |
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06030 |
| Conditions: |
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Osteoporosis - Postmenopausal Bone Loss |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
1. 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.
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| NCT ID: |
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NCT01653275 |
| Primary Contact: |
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Principal Investigator
Anne Kenny, MD
University of Connecticut Health Center
Nancy Dean
Phone: 860-679-8865
Email: NDEAN@NSO1.UCHC.EDU
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| Backup Contact: |
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Email: kenny@uchc.edu
Anne Kenny
Phone: 860-679-8865
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| Location Contact: |
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Farmington, Connecticut 06030
United States
Dean
Phone: 860-679-8865
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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