Healthy Adult Females, Healthy Adult Male, Joint Discomfort
Conditions
Keywords
olive oil extract, randomized, double-blind, placebo, joint discomfort
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.
Interventions
DIETARY_SUPPLEMENTOlive 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.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
Applied Food Sciences Inc.
Alethios, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Knee pain (KOOS Pain subscale) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Knee Stiffness | After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation. | Change in knee stiffness from baseline to Week 6. Measured by KOOS (0-100 where 0=Worst knee problems, 100=No knee problems). |
| Change in Physical Function (KOOS) | After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation. | 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). |
| Change in KOOS Composite Score | After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation. | Change in KOOS composite score from baseline to Week 6. Measured by KOOS (0-100 where 0=Worst Knee Problems, 100=No knee problems) |
| Change in Global Assessment of Joint Status | After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation | 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. |
| Change in Knee Pain Intesity | After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation | Self-perceived rating of pain using a 100-mm anchored visual analog scale. 0 = No Pain, 100 = Significant pain |
| Rescue Medication Use | Daily througout entire 6-week study protocol. | The number of doses and cadence of rescue medication use will be recorded in a digital medication log. |
| Stair Climb Test | Day 1 (before dose 1) and Week 6 | The stair climb test will be completed whereby participants will walk up and down a flight of stairs. Unit of measure: seconds. |
| Timed Up and Go Test | Day 1 (before Dose 1) and Week 6 | 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. |
| Mean Daily Step Count | Daily throughout entire protocol (Day 1 - Week 6) | 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 |
| Salivary C-Reactive Protein | Day 1 (Before Dose 1) and Week 6 | 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 |
| Salivary Interleukin-6 | Day 1 (Before Dose 1) and Week 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 |
Countries
United States
Contacts
CONTACTChristine Fields, PhD
PRINCIPAL_INVESTIGATORChad Kerksick, PhD
Outcome results
None listed