NCT01653275

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

2.7 years

First QC Date

July 26, 2012

Last Update Submit

May 8, 2017

Conditions

OsteoporosisPostmenopausal Bone Loss

Keywords

Mediterranean DietBone turnoverpostmenopausal women

Outcome Measures

Primary Outcomes (1)

  • study adherence

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

    8 months

Secondary Outcomes (1)

  • Bone turnover markers

    8 months

Study Arms (1)

Mediterranean Diet

EXPERIMENTAL

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

Interventions

Mediterranean DietOTHER

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.

Mediterranean Diet

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCHC

Farmington, Connecticut, 06030, United States

Location

Related Publications (1)

  • 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.

    PMID: 27568885RESULT

MeSH Terms

Conditions

OsteoporosisOsteoporosis, Postmenopausal

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Anne Kenny, MD

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 26, 2012

First Posted

July 30, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 10, 2017

Record last verified: 2017-05

Locations

US(1)