Strawberries and Knee Osteoarthritis (OA)

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518347
• Other study ID #: HE1517
• Status: Completed
• Phase: N/A
• First received: July 30, 2015
• Last updated: January 16, 2018
• Start date: March 2015
• Est. completion date: May 2017

Study information

• Verified date: January 2018
• Source: Oklahoma State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• FDS-Strawberry
Natural frozen and dried strawberries
• Placebo
Placebo powder matched for carbohydrates and fiber in the strawberries

Locations

Country	Name	City	State
United States	Oklahoma State University	Stillwater	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Oklahoma State University	University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores on the Visual Analog Scale		six months
Primary	Inflammatory Biomarkers in Serum		six months