Tart Cherry Supplementation and Women's Bone Health Study
Condition: Osteoporosis, Postmenopausal; Osteoporosis, Age-Related
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional

Summary: 
      In spite of aggressive approaches to prevent and treat osteoporosis, it remains one of the
      most costly and debilitating diseases associated with aging. The pursuit of alternative
      approaches for preventing bone loss has included the investigation of a number of promising
      plant-based foods that can be incorporated into the diet. This project is an extension of our
      pre-clinical studies with tart cherry, designed to determine whether the findings from our
      animal study can be extended to humans. Thus, the purpose of this project is to investigate
      the dose-dependent effect of tart cherry juice consumption on biomarkers of bone metabolism
      in women, aged 65-80 years. The hypothesis to be tested is that three months of tart cherry
      supplementation will improve bone biomarkers in a dose-dependent manner. Moreover, these
      improvements in bone metabolism will correspond to a decrease in markers of inflammation and
      oxidative stress.
    

Detailed description: 
      Tart cherries are an excellent course of phenolic compounds and anthocyanins, and in
      pre-clinical studies have been shown to prevent age-related bone loss. Based on these
      findings, this pilot study was designed to investigate the effects of three months of tart
      cherry juice supplementation on improving markers of oxidative stress and bone metabolism in
      older women. Women (n=30), aged 65-80 yrs, will be recruited for the study and randomly
      assigned to one of two doses of tart cherry juice (8 or 16 fl oz) per day prepared from a
      Montmorency cherry concentrate (King Orchards, Central Lake, MI). Study participants will
      complete two study visits to the Nutritional Sciences Clinical Research Center. At the first
      visit, informed consent will be obtained and relevant medical history and anthropometric
      measures will be taken by the research team. A blood draw will be performed to assess
      baseline, biochemical markers of bone metabolism and inflammation as well as indicators of
      oxidative status. A physical activity and food frequency questionnaire will be completed by
      each study participant. Whole body, hip and spine bone density (DXA) scan will be performed
      by certified bone densitometrist. A 3-month final visit will be scheduled for all study
      participants in which most of the procedures described at baseline (except DXA) will be
      repeated. Change in primary and secondary outcome measures (i.e., bone, inflammation and
      oxidative stress biomarkers) will be assessed.
    

Intervention name(s): tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI)
Intervention type(s): Dietary Supplement
Intervention description(s): Participants were instructed to reconstitute the tart cherry juice concentrate in 8 fl oz of water and consume either 1x or 2x daily for 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized dose-response pre-test, post-test study design
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: osteoporosis; biomarkers; tart cherry; functional food