ClinicalTrials.gg
Not yet recruitingNCT07678346Updated Jul 1, 2026

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

An interventional study of Apple Extract and Placebo in Systemic Inflammation (hsCRP), Healthy Aging and Vitality, sponsored by Nutraland USA, Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 45 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Nutraland USA, Inc. · Not applicable, Interventional, and Basic science

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Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
45 Years to 70 Years
Sex
All
01

Study 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.

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.

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.

02

Conditions studied

  • Systemic Inflammation (hsCRP)
  • Healthy Aging
  • Vitality
  • Healthy Adult Participants

Keywords

  • Apple extract
  • Fisetin
  • Flavonoids
  • polyphenols
03

In context

Lead sponsor

Nutraland USA, Inc. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 via the Alethios eConsent platform

Exclusion criteria

Exclusion Criteria:

  • Current use of prescription anti-inflammatory medications including NSAIDs (regular use ≥3x/week), , or DMARDs
  • Diagnosis of an 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
  • (BMI) >40 kg/m²
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    AppleX™ Group

    100 mg whole-apple extract capsule standardized to 15% fisetin, taken once daily with breakfast for 24 weeks.

    Dietary Supplement: Apple Extract

  • Placebo comparator
    Placebo

    An identical look-alike microcrystalline cellulose capsule, taken once daily with breakfast for 24 weeks

    Other: Placebo

Interventions

  • Dietary supplementApple Extract

    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.

    Also known as: AppleX™

  • OtherPlacebo

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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Other outcomes

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

    Time frame: Baseline (Week 0) and Week 24

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2026; primary completion for Jan 2027, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 25, 2026
First posted
Jul 1, 2026
StartEst.
Jul 2026
Primary completionEst.
Jan 2027
CompletionEst.
Feb 2027
Last update
Jul 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07678346
Collaborators
Alethios, Inc.
Responsible party
Sponsor
First posted
Jul 1, 2026
Start date
Jul 2026 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Jul 1, 2026

Study contacts

Dr. Bill Clark, Ph.D.
Contact
drbill@natprologix.com
727-365-3420
Alethios, Inc.
Contact
support@alethios.com
650-206-8006
Dr. Bill Clark, PhD
principal investigator · Natprologix, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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