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

• Sponsor: UConn Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT01653275
• Collaborator: University of Connecticut (Other)
• Enrollment: 22
• Location: 1
• Arm: 1
• Actual Duration (Months): 32
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis; Postmenopausal Bone Loss	Other: Mediterranean Diet	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Mediterranean Diet for Post-menopausal Women: Effects on Bone Turnover
• Actual Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

1. study adherence [8 months]

   Determine the extent to which postmenopausal women in the US can adhere to the MedSD intervention.

Secondary Outcome Measures

1. Bone turnover markers [8 months]

   Determine if adherence to the MedSD will result in a reduction in bone resorption markers and enhance formation markers

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCHC	Farmington	Connecticut	United States	06030

Sponsors and Collaborators

• UConn Health
• University of Connecticut

Investigators

• Principal Investigator: Anne Kenny, MD, UConn Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anne Kenny, Professor of Medicine, UConn Health
• ClinicalTrials.gov Identifier: NCT01653275
• Other Study ID Numbers: 12-136S-1
• First Posted: Jul 30, 2012
• Last Update Posted: May 10, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Anne Kenny, Professor of Medicine, UConn Health: Mediterranean Diet; Bone turnover; postmenopausal women
• Additional relevant MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal

Study Results

No Results Posted as of May 10, 2017