Examining Olive Oil Extract on Knee Comfort and Function

NCT07514013 | Recruiting

• 1 other identifier: AFS-001-OOE
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

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).

  After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation.

Secondary Outcomes (11)

• Change in Knee Stiffness

  After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation.

• Change in Physical Function (KOOS)

  After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation.

• Change in KOOS Composite Score

  After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation.

• Change in Global Assessment of Joint Status

  After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation

• Change in Knee Pain Intesity

  After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation

Other Outcomes (2)

• Sleep Quality Score

  After 0, 1, 2, 3, 4, 5, and 6 weeks of supplementation

• Elapsed time in physical activity zones

  Daily throughout entire protocol (From Day 1 to Week 6)

Study Arms (2)

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

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.

Dietary Supplement: Olive Oil Extract

Interventions

Olive Oil Extract DIETARY_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.

Olive Oil Extract

Placebo DIETARY_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.

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Applied Food Sciences Inc.: lead
• Alethios, Inc.: collaborator

Study Sites (1)

Alethios, Inc.

San Francisco, California, 94104, United States

RECRUITING

MeSH Terms

Interventions

Olive Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Chad Kerksick, PhD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Fields, PhD

CONTACT

8475508978; cfields@appliedfoods.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 7, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)