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NCT Number: NCT07678346

Evaluation of AppleX™ Apple Extract on Anti-Inflammatory and Healthy Aging Effects

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.

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Key information

Conditions

Systemic Inflammation (hsCRP) Healthy Adult Participants Healthy Aging Vitality

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 45-70 years at time of enrollment
  • Meets questionnaire-based inflammatory enrichment criteria (at least 2 of 5 risk factors, per Section 4.2)
  • Non-smoker (no tobacco or nicotine use within 6 months of enrollment)
  • Willing and able to maintain stable diet, exercise habits, and supplement use throughout the 24-week study period
  • No major medication changes planned during the study period
  • Willing to perform home-based DBS collections at T0, T12, and T24
  • Access to a smartphone or computer to complete eConsent and online questionnaires
  • Able to provide informed consent via the Alethios eConsent platform

Exclusion criteria

  • Current use of prescription anti-inflammatory medications including NSAIDs (regular use ≥3x/week), corticosteroids, or DMARDs
  • Diagnosis of an autoimmune or inflammatory disease (e.g., rheumatoid arthritis, lupus, IBD, multiple sclerosis)
  • Active or unstable cardiovascular disease requiring medication changes during the study period
  • History of cancer within the past 5 years (except non-melanoma skin cancer)
  • Regular use of supplemental fisetin, quercetin, or resveratrol within 30 days of enrollment
  • Pregnancy, breastfeeding, or planning to become pregnant during the study
  • Known allergy to apple or apple-derived products
  • Body mass index (BMI) >40 kg/m²

Treatment and study plan

Apple Extract

Dietary Supplement

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.

Other names: AppleX™

Placebo

Other

An identical, matching inactive look-alike capsule containing microcrystalline cellulose. Administered orally once daily with breakfast for 24 weeks.

Primary outcomes

  1. Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 24

    Time frame: Baseline (Week 0) and Week 24

    Evaluation of systemic inflammation via high-sensitivity C-reactive protein levels quantified from dried blood spot micro-sampling.

Secondary outcomes

  1. Change from Baseline in Self-Reported Vitality and Energy Levels at Week 24

    Time frame: Baseline, Week 12, Week 24

    Assessment of participant-reported vitality and energy using the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. Higher scores indicate greater vitality.

  2. Change from Baseline in Self-Reported Fatigue at Week 24

    Time frame: Baseline, Week 12, Week 24

    Assessment of physical and mental fatigue using the Multidimensional Fatigue Inventory (MFI-20) questionnaire. Lower scores indicate less fatigue.

  3. Change from Baseline in Self-Reported Joint Comfort at Week 24

    Time frame: Baseline, Week 12, Week 24

    Assessment of joint comfort scores captured via standardized visual analog questionnaires.

Other outcomes

  1. Exploratory: Change from Baseline in Epigenetic Aging Metrics at Week 24

    Time frame: Baseline (Week 0) and Week 24

    Evaluation of biological age and pace of aging markers derived from blood DNA methylation patterns utilizing the TruAge platform. The primary algorithm of interest is DunedinPACE (evaluating the instantaneous pace of aging). Secondary exploratory metrics evaluated from the same platform assay include OMICm Age (cumulative biological age) and organ-specific biological aging rates (including SYMPHONYAge).

Study contacts

Contact information is provided by the study sponsor or research team.

Alethios, Inc.

CONTACT

[email protected]

650-206-8006

Dr. Bill Clark, Ph.D.

CONTACT

[email protected]

727-365-3420

Sponsors and collaborators

Lead sponsor

Nutraland USA, Inc.

Industry

Collaborators

  • Alethios, Inc.

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Anti-Inflammatory and Healthy Aging Effects of AppleX™ Apple Extract (15% Fisetin) in Adults 45-70 Years of Age

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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