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Clinical Trials in Canada / NCT07812792
Starting soon Phase 2

Effect of Pentadecanoic Acid Supplementation on Red Blood Cell Health and Biological Aging in Healthy Older Adults

NCT07812792 · tracked via the Priya Life Science Canada tracker
Sponsor
ReCellience15, Inc
Phase
Phase 2
Started
2027-01
Last updated
2026-09-10

Condition(s) studied

Red Blood Cell HealthBiological AgingHealthy Aging

Investigational drug(s) / intervention(s)

Pentadecanoic AcidPlacebo

Pentadecanoic Acid: Pentadecanoic acid is administered orally as capsules once daily with the participant's first meal for approximately 12 weeks (84 ± 2 days). Participants receive one daily dose consisting of three capsules. The 200 mg/day group receives two active capsules and one placebo capsule, while the 300 mg/day group receives three active capsules. Participants take their first dose in-clinic on Day 1 and continue daily dosing at home from Day 2 through the day before the end-of-study visit.

Placebo: Placebo is administered orally as three matching placebo capsules once daily with the participant's first meal for approximately 12 weeks (84 ± 2 days). Placebo capsules are manufactured to match the active study product in physical appearance and packaging to maintain blinding.

Study summary

This Phase II randomized, double-blind, placebo-controlled, parallel-group study will evaluate the effects of pentadecanoic acid (C15:0) supplementation on red blood cell (RBC) health and predicted biological age in healthy adults aged 55 years and older. A total of 93 participants will be randomized to receive 200 mg of C15:0, 300 mg of C15:0, or placebo daily for approximately 12 weeks. The primary objective is to assess the effect of C15:0 on red blood cell distribution width (RDW-CV), a marker of RBC health, compared with placebo. Secondary outcomes include measures of inflammation, hematologic and iron metabolism markers, circulating C15:0 levels, biological age-related biomarkers, sleep quality, fatigue, energy, and health-related quality of life. Safety and tolerability will also be evaluated throughout the study.

Eligibility

Sex
ALL
Min age
55 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Adults who are 55 years or older at the time of signing the informed consent. * In otherwise good general health, as deemed by the investigator. * Are able to consume the study product capsules. * Stable medication regimen for ≥3 months * Have a BMI between 18.5 to 34.9 kg/m2 (inclusive) at baseline. * Willing and able to fast overnight (approximately 10 hours) * Have maintained consistent dietary habits, including medication and supplement intake, and lifestyle for the last 3 months before screening and agree to maintain them throughout the study (unless required per the restrictions). * Agree to follow the restrictions on concomitant treatments. * Agree to follow the restrictions on lifestyle. * Agree to use acceptable contraceptive methods. * Willing and able to agree to the requirements of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures. Exclusion Criteria: * Individuals who are pregnant, intending to breastfeed, or intending to conceive at the time of consent and during the study, or demonstrate a positive pregnancy test * Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.at baseline. * Have Type I diabetes or Type II diabetes, or uncontrolled thyroid disease ("uncontrolled" defined as being unmedicated, have an unstable use of medication within 3 months prior to screening, or have a stable use of medication for 3 months but still have uncontrolled conditions). * History of heart/cardiovascular disease (e.g. coronary artery disease, heart failure, stroke/TIA, clinically significant arrhythmia, uncontrolled hypertension). Participants receiving antihypertensive medications may be included, provided treatment has been stable for at least 8 weeks prior to screening, with no anticipated changes during the study. * Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product (e.g., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency). * Have hematologic disorders affecting RBC production. * Have fat absorption issues. * Recent blood donation (\<8 weeks). * Have a history of renal disease (dialysis or renal failure), hepatic impairment/disease, immune disorders and/or immunocompromised (i.e., HIV/AIDS). * Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer), unless recovery occurred more than 5 years before the screening visit. * Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.). * Major surgery in 3 months prior to screening or planned major surgery during the study. * Have a history of alcohol or substance abuse in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program) or use that in the opinion of the investigator may be of a concern for the study. * Current enrollment or past participation in another study with any product(s) with at least one active ingredient within 28 days before first dose of study product or longer, if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study. * Any other medical condition/situation or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Apex Trials Guelph Ontario - on

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07812792 on ClinicalTrials.gov ↗ ← All trials in Canada