Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Strawberries and Knee Osteoarthritis (OA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02518347
Recruitment Status : Completed
First Posted : August 7, 2015
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
University of Oklahoma
Information provided by (Responsible Party):
Arpita Basu, Oklahoma State University

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).

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Dietary Supplement: FDS-Strawberry Dietary Supplement: Placebo Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Freeze-dried Strawberries on Systemic Markers of Inflammation and Knee Function in Participants With Osteoarthritis (OA)
Study Start Date : March 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: FDS-Strawberry
Freeze-dried strawberry powder (50g/d)
Dietary Supplement: FDS-Strawberry
Natural frozen and dried strawberries

Placebo Comparator: Placebo
Powder matched for carbohydrates and fiber in the strawberries
Dietary Supplement: Placebo
Placebo powder matched for carbohydrates and fiber in the strawberries




Primary Outcome Measures :
  1. Pain Scores on the Visual Analog Scale [ Time Frame: six months ]
  2. Inflammatory Biomarkers in Serum [ Time Frame: six months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518347


Locations
Layout table for location information
United States, Oklahoma
Oklahoma State University
Stillwater, Oklahoma, United States, 74078
Sponsors and Collaborators
Oklahoma State University
University of Oklahoma
Investigators
Layout table for investigator information
Principal Investigator: ARPITA BASU, PHD Oklahoma State University
Layout table for additonal information
Responsible Party: Arpita Basu, Associate Professor, Oklahoma State University
ClinicalTrials.gov Identifier: NCT02518347    
Other Study ID Numbers: HE1517
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases