NCT02518347

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

1.7 years

First QC Date

July 30, 2015

Last Update Submit

January 16, 2018

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

  • Pain Scores on the Visual Analog Scale

    six months

  • Inflammatory Biomarkers in Serum

    six months

Study Arms (2)

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

FDS-StrawberryDIETARY_SUPPLEMENT

Natural frozen and dried strawberries

FDS-Strawberry
PlaceboDIETARY_SUPPLEMENT

Placebo powder matched for carbohydrates and fiber in the strawberries

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of knee osteoarthritis
  • Must have waist circumference \>35 inches for women and \>40 inches for men

You may not qualify if:

  • Cancer
  • Heart disease
  • Smoking
  • Berry allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oklahoma State University

Stillwater, Oklahoma, 74078, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • ARPITA BASU, PHD

    Oklahoma State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 30, 2015

First Posted

August 7, 2015

Study Start

March 1, 2015

Primary Completion

November 1, 2016

Study Completion

May 1, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations

US(1)