Skip to main content
OpenTrials
Completed

NCT Number: NCT01653275

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UCHC

Farmington, Connecticut, 06030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mediterranean Diet

Other

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 outcomes

  1. study adherence

    Time frame: 8 months

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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • University of Connecticut

Registry information

Acronym: MedSD

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2012
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.