Dietary Wild Blueberries and Joint Health
Effects of Dietary Wild Blueberries on Gut Health and Inflammation and Joint Pain
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Arpita Basu
- Phone Number: 702-895-4576
- Email: arpita.basu@unlv.edu
Study Locations
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- OMRF
-
Contact:
- Judy Goodman
- Phone Number: 405- 271-3007
- Email: judy-goodman@omrf.org
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults with documented multi-joint/knee arthritis
Exclusion Criteria:
- inability to give informed consent
- pregnancy or lactation
- planned knee replacement surgery
- allergy or contraindication to berries
- recent trauma of the knee responsible of the symptomatic knee
- intra-articular injection in the target knee/hip in the last 3 months
- oral corticosteroid therapy ≥ 5 mg/day (prednisone equivalent) at baseline
- use of berry extracts in the last 3 months
- special diets
- cancer treatment
- bone diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Wild blueberries
25g freeze-dried wild blueberries daily for 12 weeks
|
Freeze-dried wild blueberry powder 25g/day
|
|
Placebo Comparator: Placebo
Placebo powder free from polyphenols matched for calories
|
Placebo powder matched for calories and no polyphenols
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum biomarkers of joint function
Time Frame: 12 weeks
|
Serum biomarkers of inflammation and cartilage degradation will be measured in the wild blueberry and placebo groups and compared for outcomes.
Pain scores will also be measured using self-reported questionnaires.
|
12 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Gut microbiome
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- OMRF WB01
- WBANA01 (Other Grant/Funding Number: WBANA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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