A 6-Week, Randomized, Double-Blind, Placebo-Controlled Virtual Study Evaluating an Olive Oil Extract on Knee Comfort and Function
Applied Food Sciences Inc.
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
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…
Eligibility
- Age range
- 40–75 years
- Sex
- All
- 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…
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.
Location
- Alethios, Inc.San Francisco, California