Systemic Inflammation (hsCRP)NCT07678346
Evaluation of AppleX™ Apple Extract on Anti-Inflammatory and Healthy Aging Effects
A study testing Apple Extract in people with Systemic Inflammation (hsCRP) and Healthy Aging, run by Nutraland USA, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Inflammation (hsCRP), Healthy Aging, Vitality
- What is being tested?
- Apple Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Alethios, Inc.
San Francisco, California, 94109
Zeenia Framroze, BA MPhil, 650-206-8006, support@alethios.com
About this study
Official 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
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:
Read more
- 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.
Read the detailed description
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.
- Being tested
- Apple Extract, Placebo
- Keywords
- Apple extract, Fisetin, Flavonoids, polyphenols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple ExtractDietary supplement
Also called AppleX™
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.
PlaceboOther
An identical, matching inactive look-alike capsule containing microcrystalline cellulose. Administered orally once daily with breakfast for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| AppleX™ Group | Experimental | 100 mg whole-apple extract capsule standardized to 15% fisetin, taken once daily with breakfast for 24 weeks. Receives: Dietary Supplement: Apple Extract |
| Placebo | Placebo comparator | An identical look-alike microcrystalline cellulose capsule, taken once daily with breakfast for 24 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) and Week 24
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Inflammation (hsCRP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutraland USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alethios, Inc.
- Responsible party
- Sponsor
- Investigators
- Dr. Bill Clark, PhD, Principal investigator, Natprologix, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678346
- Sponsor's protocol ID
- NLAX-001
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No