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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oklahoma State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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