Strawberries and Knee Osteoarthritis (OA)
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FDS-Strawberry
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility 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
Sites / Locations
- Oklahoma State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
FDS-Strawberry
Placebo
Arm Description
Freeze-dried strawberry powder (50g/d)
Powder matched for carbohydrates and fiber in the strawberries
Outcomes
Primary Outcome Measures
Pain Scores on the Visual Analog Scale
Inflammatory Biomarkers in Serum
Secondary Outcome Measures
Full Information
NCT ID
NCT02518347
First Posted
July 30, 2015
Last Updated
January 16, 2018
Sponsor
Oklahoma State University
Collaborators
University of Oklahoma
1. Study Identification
Unique Protocol Identification Number
NCT02518347
Brief Title
Strawberries and Knee Osteoarthritis (OA)
Official Title
Effects of Freeze-dried Strawberries on Systemic Markers of Inflammation and Knee Function in Participants With Osteoarthritis (OA)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oklahoma State University
Collaborators
University of Oklahoma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FDS-Strawberry
Arm Type
Experimental
Arm Description
Freeze-dried strawberry powder (50g/d)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Powder matched for carbohydrates and fiber in the strawberries
Intervention Type
Dietary Supplement
Intervention Name(s)
FDS-Strawberry
Intervention Description
Natural frozen and dried strawberries
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo powder matched for carbohydrates and fiber in the strawberries
Primary Outcome Measure Information:
Title
Pain Scores on the Visual Analog Scale
Time Frame
six months
Title
Inflammatory Biomarkers in Serum
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ARPITA BASU, PHD
Organizational Affiliation
Oklahoma State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oklahoma State University
City
Stillwater
State/Province
Oklahoma
ZIP/Postal Code
74078
Country
United States
12. IPD Sharing Statement
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Strawberries and Knee Osteoarthritis (OA)
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