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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01653275
First Posted: July 30, 2012
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Connecticut
Information provided by (Responsible Party):
Anne Kenny, UConn Health
  Purpose
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 Intervention
Osteoporosis Postmenopausal Bone Loss Other: Mediterranean Diet

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mediterranean Diet for Post-menopausal Women: Effects on Bone Turnover

Further study details as provided by Anne Kenny, UConn Health:

Primary Outcome Measures:
  • study adherence [ Time Frame: 8 months ]
    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 ]
    Determine if adherence to the MedSD will result in a reduction in bone resorption markers and enhance formation markers


Enrollment: 22
Actual Study Start Date: April 2012
Study Completion Date: December 2014
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, 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.
  Eligibility

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653275


Locations
United States, Connecticut
UCHC
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
University of Connecticut
Investigators
Principal Investigator: Anne Kenny, MD UConn Health
  More Information

Publications:
Responsible Party: Anne Kenny, Professor of Medicine, UConn Health
ClinicalTrials.gov Identifier: NCT01653275     History of Changes
Other Study ID Numbers: 12-136S-1
First Submitted: July 26, 2012
First Posted: July 30, 2012
Last Update Posted: May 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: only deidentified data will be available to share

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anne Kenny, UConn Health:
Mediterranean Diet
Bone turnover
postmenopausal women

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