Strawberries and Knee Osteoarthritis (OA)

NCT ID: NCT02518347

Last Updated: 2018-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-05-31

Brief Summary

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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

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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).

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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FDS-Strawberry

Freeze-dried strawberry powder (50g/d)

Group Type EXPERIMENTAL

FDS-Strawberry

Intervention Type DIETARY_SUPPLEMENT

Natural frozen and dried strawberries

Placebo

Powder matched for carbohydrates and fiber in the strawberries

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo powder matched for carbohydrates and fiber in the strawberries

Interventions

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FDS-Strawberry

Natural frozen and dried strawberries

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo powder matched for carbohydrates and fiber in the strawberries

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oklahoma

OTHER

Sponsor Role collaborator

Oklahoma State University

OTHER

Sponsor Role lead

Responsible Party

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Arpita Basu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ARPITA BASU, PHD

Role: PRINCIPAL_INVESTIGATOR

Oklahoma State University

Locations

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Oklahoma State University

Stillwater, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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HE1517

Identifier Type: -

Identifier Source: org_study_id

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