Authors
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ReCellience15, Inc -More
Category
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Primary study
Registry of Trials»ClinicalTrials.gov
Year
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2026
This Phase II, randomized, double‐blind, placebo‐controlled, parallel‐group study isdesigned to evaluate the effects of supplemental pentadecanoic acid (C15:0) on red bloodcell (RBC) health and activity and predicted biological age in healthy older adults. Thestudy will enroll 93 generally healthy men and women aged 55 years and older who havemaintained stable dietary habits, medication and supplement use, and lifestyle practicesprior to study entry.Participants will be randomized in a 1:1:1 ratio to receive one of three interventions:C15:0 (200 mg/day), C15:0 (300 mg/day), or placebo. Study product will be administeredorally as three capsules daily for a total supplementation period of approximately 84days (12 weeks). Participants will attend a screening visit, a baseline/randomizationvisit, a Week 6 interim visit, and a Week 12 end‐of‐study visit.The primary objective is to assess the effect of C15:0 supplementation on RBC health asmeasured by change from baseline in red blood cell distribution width coefficient ofvariation (RDW‐CV) at Week 12 compared with placebo. Secondary objectives includeevaluation of effects on RDW‐CV at Week 6, systemic inflammation as measured byC‐reactive protein (CRP), hemoglobin, hematocrit, RBC count, iron and RBC metabolismmarkers (reticulocytes, mean corpuscular hemoglobin concentration, serum iron, ferritin,and transferrin saturation), circulating C15:0 concentrations, and biomarkers associatedwith biological aging.Biological aging outcomes include Phenotypic Age Acceleration (PhenoAgeAccel) score andthe specific biological age‐related biomarkers (glucose, mean corpuscular volume, whiteblood cell count and differential, creatinine, alkaline phosphatase, albumin, andlymphocyte percentage). Additional assessments will evaluate sleep quality, fatigue,energy, and health‐related quality of life using the PROMIS Sleep Disturbance 8a, PROMISFatigue 8a, Energy Visual Analog Scale, and RAND‐36 Health Survey, respectively.Exploratory analyses will assess biomarkers of biological aging and oxidative stress,including interleukin‐6 (IL‐6) and malondialdehyde (MDA). Safety evaluations will includeadverse events, vital signs, anthropometric measurements, and clinical laboratoryassessments throughout the study.The study aims to determine whether C15:0 supplementation can improve markers of RBChealth and function while positively influencing biological aging‐related pathways inhealthy older adults.
Epistemonikos ID: e6e0c8ba95faf8ffa0958e2915bf20443784f49c
First added on: Sep 11, 2026