Healthy Adult MaleNCT07514013
Examining Olive Oil Extract on Knee Comfort and Function
A study testing Olive Oil Extract in people with Healthy Adult Male and Healthy Adult Females, run by Applied Food Sciences Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male, Healthy Adult Females, Joint Discomfort
- What is being tested?
- Olive Oil Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Alethios, Inc.
San Francisco, California, 94104
Zeenia Framroze, MS, 650-208-8006, zeenia@alethios.com
Zoe Benham, BS, 650-208-8006, zoe@alethios.com
About this study
Official title: A 6-Week, Randomized, Double-Blind, Placebo-Controlled Virtual Study Evaluating an Olive Oil Extract on Knee Comfort and Function
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
Read the 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.
- Conditions
- Healthy Adult Male, Healthy Adult Females, Joint Discomfort
- Being tested
- Olive Oil Extract, Placebo
- Keywords
- olive oil extract, randomized, double-blind, placebo, joint discomfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive Oil ExtractDietary supplement
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.
PlaceboDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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 Receives: Dietary Supplement: Placebo |
| Olive Oil Extract | Experimental | 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. Receives: Dietary Supplement: Olive Oil Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation.
Secondary outcomes (11)
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).
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1 (Before Dose 1) and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study startApr 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Applied Food Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alethios, Inc.
- Responsible party
- Sponsor
- Investigators
- Chad Kerksick, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514013
- Sponsor's protocol ID
- AFS-001-OOE
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study purpose is focused upon aggregate outcomes.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Week, Randomized, Double-Blind, Placebo-Controlled Virtual Study Evaluating an Olive Oil Extract on Knee Comfort and Function
- ClinicalTrials.gov ID
- NCT07514013
- Acronym / sponsor ID
- AFS-001-OOE
- Conditions
- Healthy Adult Male, Healthy Adult Females, Joint Discomfort
- Keywords
- olive oil extract, randomized, double-blind, placebo, joint discomfort
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Applied Food Sciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- Alethios, Inc.
- Study start
- Apr 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants 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 |
| Olive Oil Extract | Experimental | Dietary Supplement: Olive Oil ExtractParticipants 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olive Oil ExtractThe 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 supplement | Olive Oil Extract |
| PlaceboThe 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. | Dietary supplement | Placebo |
Primary outcome
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).
11 secondary outcomes
Change in Knee Stiffness
Time frame: After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation.
Change in Physical Function (KOOS)
Time frame: After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation.
Change in KOOS Composite Score
Time frame: After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation.
Change in Global Assessment of Joint Status
Time frame: After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation
Change in Knee Pain Intesity
Time frame: After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation
Rescue Medication Use
Time frame: Daily througout entire 6-week study protocol.
Stair Climb Test
Time frame: Day 1 (before dose 1) and Week 6
Timed Up and Go Test
Time frame: Day 1 (before Dose 1) and Week 6
Mean Daily Step Count
Time frame: Daily throughout entire protocol (Day 1 - Week 6)
Salivary C-Reactive Protein
Time frame: Day 1 (Before Dose 1) and Week 6
Salivary Interleukin-6
Time frame: Day 1 (Before Dose 1) and Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No. Study purpose is focused upon aggregate outcomes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chad Kerksick, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olive Oil Extract in people with Healthy Adult Male and Healthy Adult Females, run by Applied Food Sciences Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Fields, PhD (8475508978, cfields@appliedfoods.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee pain (KOOS Pain subscale) (time frame: After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.