Osteoporosis, PostmenopausalNCT04167150
Tart Cherry Supplementation and Women's Bone Health Study
A study testing tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI) in people with Osteoporosis, Postmenopausal and Osteoporosis, Age-Related, run by Oklahoma State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal, Osteoporosis, Age-Related
- What is being tested?
- tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2017to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Women, 65-80 years of age
- Capacity to give informed consent
Who cannot join
- 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
Show all 14Show fewer
- Renal disease
- Cancer
- Cardiovascular disease
- Diabetes
- Respiratory disease
- Gastrointestinal diseases
- Liver disease
- Other chronic conditions that could affect bone metabolism
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma State University - Nutritional Sciences
Stillwater, Oklahoma, 74078
About this study
Official title: 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.
Read the 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.
- Being tested
- tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI)
- Keywords
- osteoporosis, biomarkers, tart cherry, functional food
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Active comparator | Participants consume 8 fl oz of tart cherry juice per day. Receives: Dietary Supplement: tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI) |
| Dose 2 | Experimental | Participants consume 2 x 8 fl oz of tart cherry juice per day. Receives: Dietary Supplement: tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone-specific alkaline phosphatase (U/L)
Bone formation marker
Measured: Change from baseline to final visits (3 month intervention)
Tartrate resistant acid phosphatase (U/L)
Bone resorption marker
Measured: Change from baseline to final visits (3 month intervention)
Secondary outcomes (2)
C-reactive protein (mg/L)
Marker of inflammation
Measured: Change from baseline to final visits (3 month intervention)
Thiobarbituric acid reactive species (TBARS) (U/L)
Marker of oxidative stress
Measured: Change from baseline to final visits (3 month intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start6 Jun 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized dose-response pre-test, post-test study design
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Collaborators
- Cherry Marketing Institute
- Responsible party
- Principal investigator, Brenda Smith, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167150
- Sponsor's protocol ID
- CMI2017-2018
- Status last verified
- Nov 2019
- First submitted
- 10 Nov 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Montmorency Tart Cherry Supplementation on Bone Biomarkers in Women Aged 65-80 Years: A Pilot Study
- ClinicalTrials.gov ID
- NCT04167150
- Acronym / sponsor ID
- CMI2017-2018
- Keywords
- osteoporosis, biomarkers, tart cherry, functional food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Collaborators
- Cherry Marketing Institute
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized dose-response pre-test, post-test study design
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Active comparator | Dietary Supplement: 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 | Experimental | Dietary Supplement: 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. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Women, 65-80 years of age
- Capacity to give informed consent
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Dose 1, Dose 2 |
Primary outcome
Bone-specific alkaline phosphatase (U/L)
Time frame: Change from baseline to final visits (3 month intervention)
Bone formation marker
Tartrate resistant acid phosphatase (U/L)
Time frame: Change from baseline to final visits (3 month intervention)
Bone resorption marker
2 secondary outcomes
C-reactive protein (mg/L)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
Related trials for Osteoporosis, Postmenopausal
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
Not yet recruiting
Effects of Sensorimotor Balance Training vs Digitally Augmented Core Stabilization in Women With Osteoporosis
Postmenopausal Osteoporosis
Active, not recruitingPhase 4
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
Osteoporosis, Postmenopausal
RecruitingPhase 4
Combined Anabolic Therapy
Osteoporosis, Postmenopausal, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI) in people with Osteoporosis, Postmenopausal and Osteoporosis, Age-Related, run by Oklahoma State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone-specific alkaline phosphatase (U/L) (time frame: Change from baseline to final visits (3 month intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.