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

Not Applicable

Completed

• Conditions: Osteoporosis; Postmenopausal Bone Loss
• Interventions: Other: Mediterranean Diet

• Registration Number: NCT01653275
• Lead Sponsor: UConn Health

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-07-26
• Study First Submitted QC: 2012-07-26
• Study First Posted: 2012-07-30
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mediterranean Diet	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.

Primary Outcome Measures

Name	Time	Method
study adherence	8 months	Determine the extent to which postmenopausal women in the US can adhere to the MedSD intervention.

Secondary Outcome Measures

Name	Time	Method
Bone turnover markers	8 months	Determine if adherence to the MedSD will result in a reduction in bone resorption markers and enhance formation markers

Trial Locations

Locations (1)

UCHC; 🇺🇸 Farmington, Connecticut, United States