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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07678346
- Acronym / sponsor ID
- NLAX-001
- Keywords
- Apple extract, Fisetin, Flavonoids, polyphenols
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Nutraland USA, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Alethios, Inc.
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AppleX™ Group | Experimental | Dietary Supplement: Apple Extract100 mg whole-apple extract capsule standardized to 15% fisetin, taken once daily with breakfast for 24 weeks. |
| Placebo | Placebo comparator | Other: PlaceboAn identical look-alike microcrystalline cellulose capsule, taken once daily with breakfast for 24 weeks |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apple ExtractAlso: 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. | Dietary supplement | AppleX™ Group |
| PlaceboAn identical, matching inactive look-alike capsule containing microcrystalline cellulose. Administered orally once daily with breakfast for 24 weeks. | Other | Placebo |
Primary outcome
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.
3 secondary outcomes
Change from Baseline in Self-Reported Vitality and Energy Levels at Week 24
Time frame: Baseline, Week 12, Week 24
Change from Baseline in Self-Reported Fatigue at Week 24
Time frame: Baseline, Week 12, Week 24
Change from Baseline in Self-Reported Joint Comfort at Week 24
Time frame: Baseline, Week 12, Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Systemic Inflammation (hsCRP)
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Not yet recruitingObservational study
Immune-Inflammatory Biomarkers in Predicting Early Cognitive Impairment in Adults With Acute Basal Ganglionic Stroke
Stroke, Post-Stroke Cognitive Impairment
Active, not recruitingObservational study
Predictive Value of Nutritional and Inflammatory Indices for Postoperative Complications After Bariatric Surgery
Obesity (BMI > 35), Morbid Obesity
RecruitingPhase 1
A Phase 1b Study to Evaluate the PK of CSL300 (Clazakizumab) in Chinese Subjects With End Stage Kidney Disease (ESKD)
End Stage Kidney Disease (ESKD)
RecruitingObservational study
The Peripheral(-Muscle) Oxygenation and Perfusion Score as a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates
Prematurity, Infections, NIRS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Bill Clark, PhD principal investigator
Natprologix, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Bill Clark, Ph.D. (727-365-3420, drbill@natprologix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 24 (time frame: Baseline (Week 0) and Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.