A 6-Week, Randomized, Double-Blind, Placebo-Controlled Virtual Study Evaluating an Olive Oil Extract on Knee Comfort and Function

Olive oil extracts contain naturally occurring bioactive compounds that are widely consumed as part of the diet and are available in dietary supplement form for general wellness use. These extracts have been studied in the context of joint comfort and inflammatory balance, and their consumption is supported by existing post-market safety experience. This study is designed to evaluate participant-reported knee comfort and function associated with daily consumption of an olive oil extract compared with placebo. The study focuses on validated questionnaires, self-administered functional movement tasks, real-world activity data collected via wearable devices, and supportive exploratory measures, reflecting typical consumer use patterns while minimizing participant burden.

Potential participants review and electronically sign an informed consent form prior to initiation of any study procedures. They will then be screened using approved screening questions. Following consent, participants complete baseline questionnaires assessing knee pain, stiffness, and function. Participants also complete two self-administered functional movement tests (Stair Climb Test and Timed Up and Go) using standardized instructions and confirm access to a compatible wearable activity-tracking device.

Participants are randomized in a 1:1, ABAB ratio to receive either the olive oil extract or a matched placebo. Participants consume one capsule daily with food for the duration of the 6-week intervention period and record daily intake. On the first day of dosing, participants complete a same-day acute assessment schedule. Prior to this assessment, participants will be given instructions to practice each assessment. These assessments consist of short, timed patient-reported outcome measures evaluating knee pain and stiffness, collected before dosing and at multiple timepoints across the day. These assessments are non-invasive and rely solely on participant self-report. Throughout the 6-week intervention period, participants complete scheduled questionnaires assessing knee pain, stiffness, physical function, and overall joint status. Participants will wear a compatible activity-tracking device to allow passive collection of daily activity data and record any use of rescue pain medications in a daily log.