Tart Cherry Supplementation and Women's Bone Health Study

November 15, 2019 updated by: Brenda Smith, Oklahoma State University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Stillwater, Oklahoma, United States, 74078
        • Oklahoma State University - Nutritional Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dose 1
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)
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.
Experimental: Dose 2
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone-specific alkaline phosphatase (U/L)
Time Frame: Change from baseline to final visits (3 month intervention)
Bone formation marker
Change from baseline to final visits (3 month intervention)
Tartrate resistant acid phosphatase (U/L)
Time Frame: Change from baseline to final visits (3 month intervention)
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)
Time Frame: Change from baseline to final visits (3 month intervention)
Marker of inflammation
Change from baseline to final visits (3 month intervention)
Thiobarbituric acid reactive species (TBARS) (U/L)
Time Frame: Change from baseline to final visits (3 month intervention)
Marker of oxidative stress
Change from baseline to final visits (3 month intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oklahoma State University

Collaborators

Cherry Marketing Institute Research Committee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2017

Primary Completion (Actual)

May 31, 2018

Study Completion (Actual)

May 31, 2018

Study Registration Dates

First Submitted

November 10, 2019

First Submitted That Met QC Criteria

November 15, 2019

First Posted (Actual)

November 18, 2019

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMI2017-2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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