Tart Cherry Supplementation and Women's Bone Health Study

NCT04167150 | Completed

• 1 other identifier: CMI2017-2018
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis, Postmenopausal; Osteoporosis, Age-Related

Keywords

osteoporosis; biomarkers; tart cherry; functional food

Outcome Measures

Primary Outcomes (2)

• Bone-specific alkaline phosphatase (U/L)

  Bone formation marker

  Change from baseline to final visits (3 month intervention)

• Tartrate resistant acid phosphatase (U/L)

  Bone resorption marker

  Change from baseline to final visits (3 month intervention)

Secondary Outcomes (2)

• C-reactive protein (mg/L)

  Change from baseline to final visits (3 month intervention)

• Thiobarbituric acid reactive species (TBARS) (U/L)

  Change from baseline to final visits (3 month intervention)

Study Arms (2)

Dose 1

ACTIVE COMPARATOR

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)

Dose 2

EXPERIMENTAL

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)

Interventions

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.

Dose 1; Dose 2

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Women, 65-80 years of age
• Capacity to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Oklahoma State University: lead
• Cherry Marketing Institute Research Committee: collaborator

Study Sites (1)

Oklahoma State University - Nutritional Sciences

Stillwater, Oklahoma, 74078, United States

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutrition

Model Details: Randomized dose-response pre-test, post-test study design

Study Record Dates

• First Submitted: November 10, 2019
• First Posted: November 18, 2019
• Study Start: June 6, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: November 18, 2019

Record last verified: 2019-11

Locations

US (1)