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临床试验/NCT07322224
NCT07322224已完成不适用

A Multi-Modal Longevity Protocol Integrating Lifestyle, Supplements, and Autologous Pro-Regenerative Cell-Conditioned Media: A Pilot Study

BlueBird Age Reversal SA1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
Change in Epigenetic Biological Age

研究概览

简要总结

This pilot study evaluated a multi-modal longevity protocol combining lifestyle optimisation, nutritional supplementation, and autologous cell-free conditioned media derived from peripheral blood-derived pro-regenerative cells (APRC-CM). Fourteen healthy adult participants completed a 17-week programme including baseline and post-intervention biomarker assessments. The primary objective was to characterise changes in biological age using DNA methylation-based epigenetic clocks, PhenoAge and other physiological and biochemical markers.

详细描述

This exploratory study investigated the biological effects of a structured, multi-modal longevity programme that included lifestyle optimisation (nutrition, exercise, sleep routines), nutritional supplementation, and autologous cell-free conditioned media (APRC-CM). APRC-CM was prepared individually for each participant from peripheral blood-derived pro-regenerative cells cultured ex vivo to produce a pro-regenerative secretome containing soluble factors and extracellular vesicles.

Participants underwent biomarker assessments at baseline and at week 17. Outcomes included measurements of epigenetic biological age, phenotypic age, inflammatory markers, metabolic markers, and other laboratory and physiological variables. The study was conducted in healthy adults and designed as a minimal-risk physiological investigation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 45 years or older
  • Generally good overall health as assessed by the study team
  • Able and willing to provide written informed consent
  • Willing to participate in all components of the study protocol, including lifestyle optimisation, nutritional supplementation, blood collection, and scheduled follow-up visits
  • Able to comply with study procedures for the duration of the intervention and assessments

排除标准

  • Presence of a major medical condition that, in the opinion of the investigators, could affect participation or safety
  • Any condition requiring hospitalization or emergency medical intervention within the past 12 months
  • Receipt of anti-aging or longevity treatments within the past six months (e.g., intravenous therapies, regenerative or cellular treatments, structured age-reversal programmes)
  • Active infectious disease at enrolment
  • Pregnancy or breastfeeding
  • Use of systemic immunomodulatory, cytotoxic, or investigational treatments in the prior 3 months
  • Any condition or circumstance that, in the judgement of the investigators, may interfere with study participation or data integrity

结局指标

主要结局

Change in Epigenetic Biological Age

时间窗: Baseline and Week 17

Biological age calculated from DNA methylation profiles using validated epigenetic clock algorithms.

Change in Epigenetic Biological Age

时间窗: Baseline and Week 17

Biological age calculated from DNA methylation profiles using validated epigenetic clock algorithms.

次要结局

  • Change in Phenotypic Age(Baseline and Week 17)

研究者

发起方
BlueBird Age Reversal SA
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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