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

Primary Purpose

Osteoporosis, Postmenopausal Bone Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mediterranean Diet
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Mediterranean Diet, Bone turnover, postmenopausal women

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • UCHC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mediterranean Diet

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 26, 2012
Last Updated
May 8, 2017
Sponsor
UConn Health
Collaborators
University of Connecticut
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1. Study Identification

Unique Protocol Identification Number
NCT01653275
Brief Title
Mediterranean Diet for Post-menopausal Women: Effects on Bone Turnover
Acronym
MedSD
Official Title
Mediterranean Diet for Post-menopausal Women: Effects on Bone Turnover
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
University of Connecticut

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal Bone Loss
Keywords
Mediterranean Diet, Bone turnover, postmenopausal women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mediterranean Diet
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Mediterranean Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
study adherence
Description
Determine the extent to which postmenopausal women in the US can adhere to the MedSD intervention.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Bone turnover markers
Description
Determine if adherence to the MedSD will result in a reduction in bone resorption markers and enhance formation markers
Time Frame
8 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Kenny, MD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCHC
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
only deidentified data will be available to share
Citations:
PubMed Identifier
27568885
Citation
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.
Results Reference
result

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

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