Examining Olive Oil Extract on Knee Comfort and Function
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorApplied Food Sciences Inc.
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Olive Oil Extract
Dietary supplementThe 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.
Placebo
Dietary supplementThe 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.
Treatment groups
168 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: Olive Oil ExtractExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.4
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 supplementationOther outcomes
1
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 supplementation2
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Applied Food Sciences Inc.
Lead sponsor
Alethios, Inc.
Collaborator
Source ClinicalTrials.gov