Evaluation of AppleX™ Apple Extract on Anti-Inflammatory and Healthy Aging Effects
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
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
Treatments tested in this trial
- Apple Extract
- Placebo
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Nutraland USA, Inc.
Lead sponsor
Alethios, Inc.
Collaborator
Source ClinicalTrials.gov