Osteoarthritis, Knee
Conditions
Brief summary
The proposed study aims to examine the hypothesis that strawberry supplementation will lower serum biomarkers of inflammation and improve knee function in patients with symptomatic osteoarthritis (OA).
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).
Interventions
DIETARY_SUPPLEMENTFDS-Strawberry
Natural frozen and dried strawberries
DIETARY_SUPPLEMENTPlacebo
Placebo powder matched for carbohydrates and fiber in the strawberries
Sponsors
University of Oklahoma
Oklahoma State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Scores on the Visual Analog Scale | six months |
| Inflammatory Biomarkers in Serum | six months |
Countries
United States
Outcome results
None listed