Mediterranean Diet for Post-menopausal Women: Effects on Bone Turnover



Status:Completed
Conditions:Osteoporosis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:65 - Any
Updated:4/2/2016
Start Date:April 2012
End Date:December 2014
Contact:Nancy Dean
Email:NDEAN@NSO1.UCHC.EDU
Phone:860-679-8865

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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.

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.

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.
We found this trial at
1
site
Farmington, Connecticut 06030
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mi
from
Farmington, CT
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