Strawberries and Knee Osteoarthritis (OA) | NCT02518347

Studies
Strawberries and Knee Osteoarthritis (OA)

NCT02518347

Sponsor

Oklahoma State University

Status

Completed

Last Update Posted

Jan 18, 2018Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Osteoarthritis, Knee

Interventions

FDS-Strawberry
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Nov 2016Actual

Completion Date

May 2017Actual

First Submitted Date

Jul 30, 2015

First Submission Date that Met QC Criteria

Aug 5, 2015

First Posted Date

Aug 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2018

Last Update Posted Date

Jan 18, 2018Actual

Name	Class
University of Oklahoma	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FDS-Strawberry	Experimental	Freeze-dried strawberry powder (50g/d)	Dietary Supplement: FDS-Strawberry
Placebo	Placebo Comparator	Powder matched for carbohydrates and fiber in the strawberries	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FDS-Strawberry	Dietary Supplement	Natural frozen and dried strawberries	FDS-Strawberry

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain Scores on the Visual Analog Scale		six months
Inflammatory Biomarkers in Serum		six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ARPITA BASU, PHD	Oklahoma State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oklahoma State University		Stillwater	Oklahoma	74078	United States

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided