Examining Olive Oil Extract on Knee Comfort and Function

Official title

A 6-Week, Randomized, Double-Blind, Placebo-Controlled Virtual Study Evaluating an Olive Oil Extract on Knee Comfort and Function

Overview

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 supplement 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.
• Dietary supplement 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 measures

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

Secondary outcome measures (11)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Basic science

Study locations

United States · 1 center

• Alethios, Inc. — San Francisco

Identifiers

NCT: NCT07514013 · AFS-001-OOE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗