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

Osteoporosis Clinical Trial

— MedSD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01653275
• Other study ID #: 12-136S-1
• Status: Completed
• Phase: N/A
• First received: July 26, 2012
• Last updated: May 8, 2017
• Start date: April 2012
• Est. completion date: December 2014

Study information

• Verified date: May 2017
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Bone Loss

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	UCHC	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	University of Connecticut

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	study adherence	Determine the extent to which postmenopausal women in the US can adhere to the MedSD intervention.	8 months
Secondary	Bone turnover markers	Determine if adherence to the MedSD will result in a reduction in bone resorption markers and enhance formation markers	8 months