Recruiting

Olive Oil Extract

Sponsor:

Applied Food Sciences Inc.

Code:

NCT07514013

Conditions

Healthy Adult Male

Healthy Adult Females

Joint Discomfort

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

Olive Oil Extract

Placebo

Study Details

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

Conditions

Healthy Adult Male

Healthy Adult Females

Joint Discomfort

Study ID

NCT07514013

Start date

Apr, 2026

Status verified date

Apr, 2026

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

168 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: 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

experimental: 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.

Interventions

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.

Placebo

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.

Primary outcome measure

  • Change in Knee pain (KOOS Pain subscale) [ Time Frame: After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation. ]

Central Contacts and Locations

Central contacts

Christine Fields, PhD

8475508978cfields@appliedfoods.com

Locations

Alethios, Inc.

Recruiting

San Francisco, California, United States, 94104

Contacts

Zeenia Framroze, MS

650-208-8006zeenia@alethios.com

Zoe Benham, BS

650-208-8006zoe@alethios.com

More Information

Sponsor

Applied Food Sciences Inc.

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • olive oil extract
  • randomized
  • double-blind
  • placebo
  • joint discomfort

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Applied Food Sciences Inc. on 2026-04-15.