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Tart Cherry Supplementation and Women's Bone Health Study

Primary Purpose

Osteoporosis, Postmenopausal, Osteoporosis, Age-Related

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI)
Sponsored by
Oklahoma State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis, Postmenopausal focused on measuring osteoporosis, biomarkers, tart cherry, functional food

Eligibility Criteria

65 Years - 80 Years (Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Oklahoma State University - Nutritional Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Dose 1

Dose 2

Arm Description

Participants consume 8 fl oz of tart cherry juice per day.

Participants consume 2 x 8 fl oz of tart cherry juice per day.

Outcomes

Primary Outcome Measures

Bone-specific alkaline phosphatase (U/L)
Bone formation marker
Tartrate resistant acid phosphatase (U/L)
Bone resorption marker

Secondary Outcome Measures

C-reactive protein (mg/L)
Marker of inflammation
Thiobarbituric acid reactive species (TBARS) (U/L)
Marker of oxidative stress

Full Information

First Posted
November 10, 2019
Last Updated
November 15, 2019
Sponsor
Oklahoma State University
Collaborators
Cherry Marketing Institute Research Committee
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1. Study Identification

Unique Protocol Identification Number
NCT04167150
Brief Title
Tart Cherry Supplementation and Women's Bone Health Study
Official Title
Effect of Montmorency Tart Cherry Supplementation on Bone Biomarkers in Women Aged 65-80 Years: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oklahoma State University
Collaborators
Cherry Marketing Institute Research Committee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal, Osteoporosis, Age-Related
Keywords
osteoporosis, biomarkers, tart cherry, functional food

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized dose-response pre-test, post-test study design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose 1
Arm Type
Active Comparator
Arm Description
Participants consume 8 fl oz of tart cherry juice per day.
Arm Title
Dose 2
Arm Type
Experimental
Arm Description
Participants consume 2 x 8 fl oz of tart cherry juice per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI)
Intervention Description
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 Outcome Measure Information:
Title
Bone-specific alkaline phosphatase (U/L)
Description
Bone formation marker
Time Frame
Change from baseline to final visits (3 month intervention)
Title
Tartrate resistant acid phosphatase (U/L)
Description
Bone resorption marker
Time Frame
Change from baseline to final visits (3 month intervention)
Secondary Outcome Measure Information:
Title
C-reactive protein (mg/L)
Description
Marker of inflammation
Time Frame
Change from baseline to final visits (3 month intervention)
Title
Thiobarbituric acid reactive species (TBARS) (U/L)
Description
Marker of oxidative stress
Time Frame
Change from baseline to final visits (3 month intervention)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Oklahoma State University - Nutritional Sciences
City
Stillwater
State/Province
Oklahoma
ZIP/Postal Code
74078
Country
United States

12. IPD Sharing Statement

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Tart Cherry Supplementation and Women's Bone Health Study

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