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

NCT07678346 | Not Yet Recruiting

• 1 other identifier: NLAX-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Apple extract; Fisetin; Flavonoids; polyphenols

Outcome Measures

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.

  Baseline (Week 0) and Week 24

Secondary Outcomes (3)

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

  Baseline, Week 12, Week 24

• Change from Baseline in Self-Reported Fatigue at Week 24

  Baseline, Week 12, Week 24

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

  Baseline, Week 12, Week 24

Other Outcomes (1)

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

  Baseline (Week 0) and Week 24

Study Arms (2)

AppleX™ Group

EXPERIMENTAL

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

Dietary Supplement: Apple Extract

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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.

Also known as: AppleX™

AppleX™ Group

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutraland USA, Inc.: lead
• Alethios, Inc.: collaborator

Study Sites (1)

Alethios, Inc.

San Francisco, California, 94109, United States

Location

MeSH Terms

Interventions

apple polyphenol extract

Study Officials

• Dr. Bill Clark, PhD

  Natprologix, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Bill Clark, Ph.D.

CONTACT

727-365-3420; drbill@natprologix.com

Alethios, Inc.

CONTACT

650-206-8006; support@alethios.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)