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

This study is currently recruiting participants.
Verified July 2012 by University of Connecticut Health Center
Sponsor:
Collaborator:
University of Connecticut
Information provided by (Responsible Party):
Anne Kenny, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01653275
First received: July 26, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  Purpose

We 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 Intervention
Osteoporosis
Postmenopausal Bone Loss
Other: Mediterranean Diet

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mediterranean Diet for Post-menopausal Women: Effects on Bone Turnover

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • study adherence [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Determine the extent to which postmenopausal women in the US can adhere to the MedSD intervention.


Secondary Outcome Measures:
  • Bone turnover markers [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Determine if adherence to the MedSD will result in a reduction in bone resorption markers and enhance formation markers


Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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, we 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. We 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. We 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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. postmenopausal women > 65 years; 2) BMI<30 kg/m2; 3) able to travel to clinical sites for follow-up visits; 4) willing to make no changes to habitual physical activity or calcium and vitamin D intake for the study duration

Exclusion Criteria:

  • 1) any disease that may affect bone metabolism, (i.e Paget's disease, primary hyperparathyroidism); 2) cancers of any kind (except basal or squamous cell of skin) in past 5 years; 3) use of medication known to affect bone metabolism; 6) extreme dietary behaviors or supplementation in excess of DRI upper limits; 7) following a medically prescribed diet or dietary pattern similar to the MedSD; 9) history of chronic renal or liver disease; 10) history of hip fracture or known vertebral fracture within the past year; 11) persons with an allergy to fish or nuts.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653275

Contacts
Contact: Nancy Dean 860-679-8865 NDEAN@NSO1.UCHC.EDU
Contact: Anne Kenny 860-679-8865 kenny@uchc.edu

Locations
United States, Connecticut
UCHC Recruiting
Farmington, Connecticut, United States, 06030
Contact: Dean    860-679-8865      
Principal Investigator: Anne Kenny, MD         
Sponsors and Collaborators
University of Connecticut Health Center
University of Connecticut
Investigators
Principal Investigator: Anne Kenny, MD University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: Anne Kenny, Professor of Medicine, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01653275     History of Changes
Other Study ID Numbers: 12-136S-1
Study First Received: July 26, 2012
Last Updated: July 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Connecticut Health Center:
Mediterranean Diet
Bone turnover
postmenopausal women

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 16, 2014