- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02518347
Strawberries and Knee Osteoarthritis (OA)
Effects of Freeze-dried Strawberries on Systemic Markers of Inflammation and Knee Function in Participants With Osteoarthritis (OA)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators propose the following two specific aims in a randomized crossover placebo-controlled trial in participants with two or more features of the metabolic syndrome and symptomatic osteoarthritis in this 12-week efficacy study:
Aim 1: To assess the effects of strawberries on biomarkers of inflammation [serum levels of C-reactive protein: CRP; inflammatory cytokines: interleukin-6: IL-6; interleukin 1β: IL-1β; tumor necrosis factor-alpha: TNFα] Aim 2: To assess the effects of strawberries on knee function as assessed by overall musculoskeletal examination and pain score (ICOAP, KOOS and HAQ-DI).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oklahoma
-
Stillwater, Oklahoma, United States, 74078
- Oklahoma State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of knee osteoarthritis
- Must have waist circumference >35 inches for women and >40 inches for men
Exclusion Criteria:
- Cancer
- Heart disease
- Smoking
- Berry allergy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FDS-Strawberry
Freeze-dried strawberry powder (50g/d)
|
Natural frozen and dried strawberries
|
Placebo Comparator: Placebo
Powder matched for carbohydrates and fiber in the strawberries
|
Placebo powder matched for carbohydrates and fiber in the strawberries
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain Scores on the Visual Analog Scale
Time Frame: six months
|
six months
|
Inflammatory Biomarkers in Serum
Time Frame: six months
|
six months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Arpita Basu, Phd, Oklahoma State University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HE1517
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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