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

NCT ID: NCT01653275

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-12-31

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.

Conditions

Osteoporosis; Postmenopausal Bone Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mediterranean Diet

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Connecticut

OTHER

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Anne Kenny

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Kenny, MD

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

UCHC

Farmington, Connecticut, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 27568885 (View on PubMed)

Other Identifiers

12-136S-1

Identifier Type: -

Identifier Source: org_study_id