Tart Cherry Supplementation and Women's Bone Health Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Montmorency Tart Cherry Supplementation on Bone Biomarkers in Women Aged 65-80 Years: A Pilot Study

Conditions
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Osteoporosis, Postmenopausal, Osteoporosis, Age-Related

Intervention / Treatment
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* Dietary Supplement: tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women, 65-80 years of age Capacity to give informed consent Exclusion Criteria: Hormone replacement therapy in the 3 months prior to starting the study Bisphosphonates in the 3 months prior to starting the study Raloxifene in the 3 months prior to starting the study Intermittent parathyroid hormone in the 3 months prior to starting the study Growth hormone or steroids in the 3 months prior to starting the study Osteoporosis Renal disease Cancer Cardiovascular disease Diabetes Respiratory disease Gastrointestinal diseases Liver disease Other chronic conditions that could affect bone metabolism

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized dose-response pre-test, post-test study design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dose 1<br>Participants consume 8 fl oz of tart cherry juice per day. | Dietary Supplement: tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI)<br>* 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.<br>|
| Experimental: Dose 2<br>Participants consume 2 x 8 fl oz of tart cherry juice per day. | Dietary Supplement: tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone-specific alkaline phosphatase (U/L) | Bone formation marker | Change from baseline to final visits (3 month intervention) | 
| Tartrate resistant acid phosphatase (U/L) | Bone resorption marker | Change from baseline to final visits (3 month intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein (mg/L) | Marker of inflammation | Change from baseline to final visits (3 month intervention) | 
| Thiobarbituric acid reactive species (TBARS) (U/L) | Marker of oxidative stress | Change from baseline to final visits (3 month intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, biomarkers, tart cherry, functional food