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临床试验/NCT01653275
NCT01653275已完成不适用

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

UConn Health2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2012年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
2
主要终点
study adherence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

study adherence

时间窗: 8 months

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

次要结局

  • Bone turnover markers(8 months)

研究者

发起方
UConn Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Kenny

Professor of Medicine

UConn Health

研究点 (2)

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