This trial is active, not recruiting.

Condition osteoarthritis, knee
Treatments fds-strawberry, placebo
Sponsor Oklahoma State University
Collaborator University of Oklahoma
Start date March 2015
End date December 2016
Trial size 20 participants
Trial identifier NCT02518347, HE1517


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Freeze-dried strawberry powder (50g/d)
Natural frozen and dried strawberries
(Placebo Comparator)
Powder matched for carbohydrates and fiber in the strawberries
Placebo powder matched for carbohydrates and fiber in the strawberries

Primary Outcomes

Pain Scores on the Visual Analog Scale
time frame: six months
Inflammatory Biomarkers in Serum
time frame: six months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Effects of Freeze-dried Strawberries on Systemic Markers of Inflammation and Knee Function in Participants With Osteoarthritis (OA)
Principal investigator ARPITA BASU, PHD
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 and HAQ-DI).
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Oklahoma State University.