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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Alethios, Inc.
- Número de telefone: 650-206-8006
- E-mail: support@alethios.com
Estude backup de contato
- Nome: Dr. Bill Clark, Ph.D.
- Número de telefone: 727-365-3420
- E-mail: drbill@natprologix.com
Locais de estudo
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California
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San Francisco, California, Estados Unidos, 94109
- Alethios, Inc.
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Contato:
- Zeenia Framroze, BA MPhil
- Número de telefone: 650-206-8006
- E-mail: support@alethios.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
Outros nomes:
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Comparador de Placebo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 24
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline in Self-Reported Vitality and Energy Levels at Week 24
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Exploratory: Change from Baseline in Epigenetic Aging Metrics at Week 24
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NLAX-001
Plano para dados de participantes individuais (IPD)
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