The goal of this clinical trial is to learn if AppleX™ Apple Extract can help lower systemic inflammation in adults aged 45-70 with signs of low-grade inflammation. It will also look at the extract's effects on fatigue, joint comfort, and biological aging metrics. The main questions it aims to answer are: * Does taking AppleX™ Apple Extract daily lower high-sensitivity C-reactive protein (hsCRP) levels, a key marker of inflammation in the blood? * Does AppleX™ Apple Extract improve participant-reported fatigue and joint comfort? * Does the extract slow down biological or epigenetic aging metrics compared to a placebo? Researchers will compare AppleX™ Apple Extract to a placebo (a look-alike capsule that contains no active ingredients) to see if the apple extract has a measurable anti-inflammatory and healthy aging effect.
AppleX™ is a whole-apple extract standardized to 15% fisetin, delivering 15 mg of active fisetin within a natural polyphenol matrix of quercetin, chlorogenic acid, and procyanidins. This trial evaluates the physiological effects of continuous, lower-dose daily intake (100 mg/day) over a 24-week period, specifically targeting an aging population sample with mild systemic inflammatory burden. The study utilizes a fully decentralized clinical trial framework. Biological metrics are collected remotely utilizing home-based, finger-prick dried blood spot (DBS) micro-sampling methodologies to minimize participant burden. In addition to evaluating systemic inflammation through longitudinal tracking of high-sensitivity C-Reactive Protein (hsCRP), the protocol investigates cellular aging by assessing DNA methylation data. This exploratory analysis utilizes the TruAge testing platform (TruDiagnostic) to evaluate advanced biological clocks, including the DunedinPACE pace-of-aging algorithm and targeted organ-system sub-clocks focused specifically on immune and inflammatory aging profiles.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
70
A whole-apple extract standardized to 15% fisetin within a natural polyphenol matrix of quercetin, chlorogenic acid, and procyanidins. Administered as a 100 mg capsule taken orally once daily with breakfast for 24 weeks.
An identical, matching inactive look-alike capsule containing microcrystalline cellulose. Administered orally once daily with breakfast for 24 weeks.
Alethios, Inc.
San Francisco, California, United States
Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 24
Evaluation of systemic inflammation via high-sensitivity C-reactive protein levels quantified from dried blood spot micro-sampling.
Time frame: Baseline (Week 0) and Week 24
Change from Baseline in Self-Reported Vitality and Energy Levels at Week 24
Assessment of participant-reported vitality and energy using the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. Higher scores indicate greater vitality.
Time frame: Baseline, Week 12, Week 24
Change from Baseline in Self-Reported Fatigue at Week 24
Assessment of physical and mental fatigue using the Multidimensional Fatigue Inventory (MFI-20) questionnaire. Lower scores indicate less fatigue.
Time frame: Baseline, Week 12, Week 24
Change from Baseline in Self-Reported Joint Comfort at Week 24
Assessment of joint comfort scores captured via standardized visual analog questionnaires.
Time frame: Baseline, Week 12, Week 24
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