An interventional study of Olive Oil Extract and Placebo in Healthy Adult Male, Healthy Adult Females and Joint Discomfort, sponsored by Applied Food Sciences Inc.. Recruiting at 1 site in United States. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Applied Food Sciences Inc. · Not applicable, Interventional, and Basic science
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:
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.
Applied Food Sciences Inc. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants must meet all of the following criteria to be eligible for participation:
Exclusion Criteria:
Participants will be excluded if any of the following apply:
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
Dietary Supplement: Placebo
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.
Dietary Supplement: Olive Oil Extract
The investigational product is an olive oil extract dietary supplement formulated for oral consumption. The product is provided in capsule form and is intended for general wellness use, including support of joint comfort and function. Each capsule delivers a standardized amount of olive-derived bioactive compounds, including oleocanthal and oleacein.
The comparator product is a matched placebo formulated from refined olive oil extract and is similar in appearance, taste, and packaging to the investigational product. The placebo is intended to serve as a control for study comparisons and does not contain the standardized olive-derived bioactive compounds present in the investigational product.
Change in Knee pain (KOOS Pain subscale)
Change in knee pain from baseline to Week 6. Measured by KOOS (0-100 where 0=Worst knee problems, 100=No knee problems).
Time frame: After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation.
Change in Knee Stiffness
Change in knee stiffness from baseline to Week 6. Measured by KOOS (0-100 where 0=Worst knee problems, 100=No knee problems).
Time frame: After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation.
Change in Physical Function (KOOS)
Self-perceived change in physical function from baseline to Week 6. Measured by KOOS (0-100 where 0=Worst knee problems, 100=No knee problems).
Time frame: After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation.
Change in KOOS Composite Score
Change in KOOS composite score from baseline to Week 6. Measured by KOOS (0-100 where 0=Worst Knee Problems, 100=No knee problems)
Time frame: After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation.
Change in Global Assessment of Joint Status
A perceived assessment of global joint status using a 100-mm digital visual analog scale. 0=No problems with joints, 100=Extreme problems with joints.
Time frame: After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation
Change in Knee Pain Intesity
Self-perceived rating of pain using a 100-mm anchored visual analog scale. 0 = No Pain, 100 = Significant pain
Time frame: After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation
Rescue Medication Use
The number of doses and cadence of rescue medication use will be recorded in a digital medication log.
Time frame: Daily througout entire 6-week study protocol.
Stair Climb Test
The stair climb test will be completed whereby participants will walk up and down a flight of stairs. Unit of measure: seconds.
Time frame: Day 1 (before dose 1) and Week 6
Timed Up and Go Test
Measure of functional performance where participants are timed (in seconds) for the amount of time it someone to stand up from a chair, walk to a spot 10 feet away, turned around and sit back down in the chair. Unit of measure: seconds.
Time frame: Day 1 (before Dose 1) and Week 6
Mean Daily Step Count
Average daily number of steps. Optional assessment for people who have a wearable deviced that can record the number of steps completed. Unit of measure: average number of steps per day
Time frame: Daily throughout entire protocol (Day 1 - Week 6)
Salivary C-Reactive Protein
Using an at-home passive drool kit, saliva samples will be collected and C-Reactive protein will be measured in each sample. Unit of measure: pg/mL
Time frame: Day 1 (Before Dose 1) and Week 6
Salivary Interleukin-6
Using an at-home passive drool kit, saliva samples will be collected and Interleukin-6 will be measured in each sample. Unit of measure: pg/mL
Time frame: Day 1 (Before Dose 1) and Week 6
Sleep Quality Score
Using a short-form digital questionnaire and an optional wearable device to track sleep and readiness scores. The digital questionnaire will evaluate sleep efficiency based upon a scale of 0-100 with a higher score indicating a better score and more efficient sleep. The questionnaire will also evaluate time (seconds) in bed and time (seconds) asleep.
Time frame: After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation
Elapsed time in physical activity zones
From optional wearable device, the amount of time spent per day in each activity zone will be evaluated. Unit of measure = Time (minutes:Seconds) spent in each zone.
Time frame: Daily throughout entire protocol (From Day 1 to Week 6)
Plan to share: No — Study purpose is focused upon aggregate outcomes.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Applied Food Sciences Inc.