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Набор скоро начнётся NCT07678346

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

Без фазы С лечением Systemic Inflammation (hsCRP) Healthy Aging Vitality Healthy Adult Participants

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Apple Extract, Placebo.
Кому может быть актуально
Состояния в реестре: Systemic Inflammation (hsCRP), Healthy Aging, Vitality, Healthy Adult Participants. Базовые параметры: 45 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Пищевая добавка Apple Extract
    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.
  • Другое Placebo
    An identical, matching inactive look-alike capsule containing microcrystalline cellulose. Administered orally once daily with breakfast for 24 weeks.

Первичные конечные точки

  • Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 24 [Срок оценки: Baseline (Week 0) and Week 24]
Вторичные конечные точки (3)
  • Change from Baseline in Self-Reported Vitality and Energy Levels at Week 24 [Срок оценки: Baseline, Week 12, Week 24]
  • Change from Baseline in Self-Reported Fatigue at Week 24 [Срок оценки: Baseline, Week 12, Week 24]
  • Change from Baseline in Self-Reported Joint Comfort at Week 24 [Срок оценки: Baseline, Week 12, Week 24]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Alethios, Inc. — San Francisco

Идентификаторы

NCT: NCT07678346 · NLAX-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗