Clinical trial NCT01653275: Mediterranean Diet for Post-menopausal Women: Effects on Bone Turnover
Official title: Mediterranean Diet for Post-menopausal Women: Effects on Bone Turnover
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Postmenopausal Bone Loss
Keywords: Mediterranean Diet
Bone turnover
postmenopausal women
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: University of Connecticut
First posted: 2012-07-30
Enrollment: 22
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: study adherence
timeFrame: 8 months
Secondary outcomes:
measure: Bone turnover markers
timeFrame: 8 months
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UCHC
state: Connecticut
Study officials:
affiliation: UConn Health
name: Anne Kenny, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.