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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Alethios, Inc.
- 電話番号：650-206-8006
- メール：support@alethios.com
研究連絡先のバックアップ
- 名前：Dr. Bill Clark, Ph.D.
- 電話番号：727-365-3420
- メール：drbill@natprologix.com
研究場所
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California
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San Francisco、California、アメリカ、94109
- Alethios, Inc.
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コンタクト：
- Zeenia Framroze, BA MPhil
- 電話番号：650-206-8006
- メール：support@alethios.com
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：AppleX™ Group
100 mg whole-apple extract capsule standardized to 15% fisetin, taken once daily with breakfast for 24 weeks.
|
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.
他の名前：
|
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プラセボコンパレーター：Placebo
An identical look-alike microcrystalline cellulose capsule, taken once daily with breakfast for 24 weeks
|
An identical, matching inactive look-alike capsule containing microcrystalline cellulose.
Administered orally once daily with breakfast for 24 weeks.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 24
時間枠：Baseline (Week 0) and 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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline in Self-Reported Vitality and Energy Levels at Week 24
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Exploratory: Change from Baseline in Epigenetic Aging Metrics at Week 24
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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