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NCT Number: NCT04167150

Tart Cherry Supplementation and Women's Bone Health Study

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.

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Key information

Conditions

Osteoporosis, Postmenopausal Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Age-Related

Age range

65 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oklahoma State University - Nutritional Sciences

Stillwater, Oklahoma, 74078, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI)

Dietary Supplement

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.

Primary outcomes

  1. Bone-specific alkaline phosphatase (U/L)

    Time frame: Change from baseline to final visits (3 month intervention)

    Bone formation marker

  2. Tartrate resistant acid phosphatase (U/L)

    Time frame: Change from baseline to final visits (3 month intervention)

    Bone resorption marker

Secondary outcomes

  1. C-reactive protein (mg/L)

    Time frame: Change from baseline to final visits (3 month intervention)

    Marker of inflammation

  2. Thiobarbituric acid reactive species (TBARS) (U/L)

    Time frame: Change from baseline to final visits (3 month intervention)

    Marker of oxidative stress

Sponsors and collaborators

Lead sponsor

Oklahoma State University

Other

Collaborators

  • Cherry Marketing Institute

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 18, 2019
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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