Tart Cherry Supplementation and Women's Bone Health Study

Not Applicable

Completed

• Conditions: Osteoporosis, Postmenopausal; Osteoporosis, Age-Related
• Interventions: Dietary Supplement: tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI)

• Registration Number: NCT04167150
• Lead Sponsor: Oklahoma State University

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 Timeline

• Study Start: 2017-06-06
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Status Verified: 2019-11
• Study First Submitted: 2019-11-10
• Study First Submitted QC: 2019-11-15
• Last Update Submitted: 2019-11-15
• Study First Posted: 2019-11-18
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

Inclusion Criteria

• Women, 65-80 years of age
• Capacity to give informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 1	tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI)	Participants consume 8 fl oz of tart cherry juice per day.
Dose 2	tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI)	Participants consume 2 x 8 fl oz of tart cherry juice per day.

Primary Outcome Measures

Name	Time	Method
Tartrate resistant acid phosphatase (U/L)	Change from baseline to final visits (3 month intervention)	Bone resorption marker
Bone-specific alkaline phosphatase (U/L)	Change from baseline to final visits (3 month intervention)	Bone formation marker

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Oklahoma State University - Nutritional Sciences; 🇺🇸 Stillwater, Oklahoma, United States