Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
NCT ID:
NCT04167150
Brief 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.
Study:
NCT04167150
Study Brief:
Protocol Section:
NCT04167150