A 6-Week, Randomized, Double-Blind, Placebo-Controlled Virtual Study Evaluating an Olive Oil Extract on Knee Comfort and Function
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 168
- Locations
- 1
- Primary Endpoint
- Change in Knee pain (KOOS Pain subscale)
Study Overview
Brief Summary
The goal of this study is to learn if an olive oil extract works to improve knee pain and discomfort in adults. The main questions it aims to answer are: 1) Does the olive oil extract improve the perceptions of knee pain and discomfort, and 2) Does the olive oil extract improve knee function in adults?
The main procedures in the study include:
- Screening and informed consent
- Take one assigned study capsule (supplement or placebo) daily with food for 6 weeks
- Complete digital questionnaires about your knee pain, stiffness, and function at scheduled times
- Complete a Day 1 acute assessment and two simple functional movement tests at home as described below
- If possible, connect a compatible wearable device to allow collection of sleep and physical activity data as detailed below.
- Collect saliva samples at home using a provided kit at designated timepoints
- Record any pain medications taken during the study or any side effects
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants must meet all of the following criteria to be eligible for participation:
- •Adults aged 40 to 75 years
- •Self-reported knee discomfort for at least 3 months
- •Willing and able to take one study capsule daily for the duration of the study
- •Willing and able to complete digital questionnaires, functional movement tasks, and other study activities using the Alethios platform
- •Willing and able to wear a compatible activity-tracking device throughout the study
- •Willing and able to collect saliva samples at home using a provided kit, if applicable
- •Able to read and understand English
- •Willing to provide informed consent electronically
Exclusion Criteria
- •Participants will be excluded if any of the following apply:
- •Diagnosis of inflammatory joint disease (e.g., rheumatoid arthritis) or other systemic inflammatory conditions affecting the knee
- •Any current or prior diagnosis from a licensed medical provider of knee disease
- •Knee surgery or significant knee injury within the past 6 months
- •Planned knee surgery during the study period
- •Known allergy or sensitivity to olive-derived products or any component of the study product
- •Current use of investigational drugs or participation in another research study during the study period
- •Any medical condition or circumstance that, in the opinion of the investigator, would make participation unsafe or interfere with study participation or data quality
Arms & Interventions
Placebo
Participants randomized to this arm will receive a matched placebo capsule taken once daily with food for 6 weeks. The placebo is formulated to be similar in appearance, taste, and packaging to the investigational product but does not contain the active olive-derived bioactive compounds
Intervention: Placebo (Dietary Supplement)
Olive Oil Extract
Participants randomized to this arm will receive an olive oil extract dietary supplement capsule taken once daily with food for 6 weeks. The supplement delivers olive-derived bioactive compounds (including oleocanthal and oleacein) and is intended for general wellness use related to joint comfort and function.
Intervention: Olive Oil Extract (Dietary Supplement)
Outcomes
Primary Outcomes
Change in Knee pain (KOOS Pain subscale)
Time Frame: After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation.
Change in knee pain from baseline to Week 6. Measured by KOOS (0-100 where 0=Worst knee problems, 100=No knee problems).
Secondary Outcomes
- Change in Knee Stiffness(After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation.)
- Change in Physical Function (KOOS)(After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation.)
- Change in KOOS Composite Score(After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation.)
- Change in Global Assessment of Joint Status(After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation)
- Change in Knee Pain Intesity(After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation)
- Rescue Medication Use(Daily througout entire 6-week study protocol.)
- Stair Climb Test(Day 1 (before dose 1) and Week 6)
- Timed Up and Go Test(Day 1 (before Dose 1) and Week 6)
- Mean Daily Step Count(Daily throughout entire protocol (Day 1 - Week 6))
- Salivary C-Reactive Protein(Day 1 (Before Dose 1) and Week 6)
- Salivary Interleukin-6(Day 1 (Before Dose 1) and Week 6)