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Completed

NCT Number: NCT02518347

Strawberries and Knee Osteoarthritis (OA)

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).

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oklahoma State University

Stillwater, Oklahoma, 74078, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FDS-Strawberry

Dietary Supplement

Natural frozen and dried strawberries

Placebo

Dietary Supplement

Placebo powder matched for carbohydrates and fiber in the strawberries

Primary outcomes

  1. Pain Scores on the Visual Analog Scale

    Time frame: six months

  2. Inflammatory Biomarkers in Serum

    Time frame: six months

Sponsors and collaborators

Lead sponsor

Oklahoma State University

Other

Collaborators

  • University of Oklahoma

Registry information

Official study title

Effects of Freeze-dried Strawberries on Systemic Markers of Inflammation and Knee Function in Participants With Osteoarthritis (OA)

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Aug 7, 2015
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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