Evaluation of AppleX™ Apple Extract on Anti-Inflammatory and Healthy Aging Effects
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:
- 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Alethios, Inc.
- Número de teléfono: 650-206-8006
- Correo electrónico: support@alethios.com
Copia de seguridad de contactos de estudio
- Nombre: Dr. Bill Clark, Ph.D.
- Número de teléfono: 727-365-3420
- Correo electrónico: drbill@natprologix.com
Ubicaciones de estudio
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California
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San Francisco, California, Estados Unidos, 94109
- Alethios, Inc.
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Contacto:
- Zeenia Framroze, BA MPhil
- Número de teléfono: 650-206-8006
- Correo electrónico: support@alethios.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 informed consent via the Alethios eConsent platform
Exclusion Criteria:
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: AppleX™ Group
100 mg whole-apple extract capsule standardized to 15% fisetin, taken once daily with breakfast for 24 weeks.
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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.
Otros nombres:
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Comparador de placebos: Placebo
An identical look-alike microcrystalline cellulose capsule, taken once daily with breakfast for 24 weeks
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An identical, matching inactive look-alike capsule containing microcrystalline cellulose.
Administered orally once daily with breakfast for 24 weeks.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 24
Periodo de tiempo: Baseline (Week 0) and Week 24
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Evaluation of systemic inflammation via high-sensitivity C-reactive protein levels quantified from dried blood spot micro-sampling.
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Baseline (Week 0) and Week 24
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline in Self-Reported Vitality and Energy Levels at Week 24
Periodo de tiempo: Baseline, Week 12, Week 24
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Assessment of participant-reported vitality and energy using the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.
Higher scores indicate greater vitality.
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Baseline, Week 12, Week 24
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Change from Baseline in Self-Reported Fatigue at Week 24
Periodo de tiempo: Baseline, Week 12, Week 24
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Assessment of physical and mental fatigue using the Multidimensional Fatigue Inventory (MFI-20) questionnaire.
Lower scores indicate less fatigue.
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Baseline, Week 12, Week 24
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Change from Baseline in Self-Reported Joint Comfort at Week 24
Periodo de tiempo: Baseline, Week 12, Week 24
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Assessment of joint comfort scores captured via standardized visual analog questionnaires.
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Baseline, Week 12, Week 24
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Exploratory: Change from Baseline in Epigenetic Aging Metrics at Week 24
Periodo de tiempo: Baseline (Week 0) and Week 24
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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).
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Baseline (Week 0) and Week 24
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Dr. Bill Clark, PhD, Natprologix, LLC
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NLAX-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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