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

ConditionsSystemic Inflammation (hsCRP)Healthy Aging Vitality Healthy Adult Participants

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age45-70

SponsorNutraland USA, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: AppleX™ GroupExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

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

Other outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nutraland USA, Inc.

Lead sponsor

Alethios, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: