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

A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Effects and Impacts of Supplemental Pentadecanoic Acid on Red Blood Cell Health and Activity and Predicted Biological Age in Healthy Older Adults

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.

This Phase II, randomized, double-blind, placebo-controlled, parallel-group study is designed to evaluate the effects of supplemental pentadecanoic acid (C15:0) on red blood cell (RBC) health and activity and predicted biological age in healthy older adults. The study will enroll 93 generally healthy men and women aged 55 years and older who have maintained stable dietary habits, medication and supplement use, and lifestyle practices prior 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 administered orally as three capsules daily for a total supplementation period of approximately 84 days (12 weeks). Participants will attend a screening visit, a baseline/randomization visit, 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 as measured by change from baseline in red blood cell distribution width coefficient of variation (RDW-CV) at Week 12 compared with placebo. Secondary objectives include evaluation of effects on RDW-CV at Week 6, systemic inflammation as measured by C-reactive protein (CRP), hemoglobin, hematocrit, RBC count, iron and RBC metabolism markers (reticulocytes, mean corpuscular hemoglobin concentration, serum iron, ferritin, and transferrin saturation), circulating C15:0 concentrations, and biomarkers associated with biological aging.

Biological aging outcomes include Phenotypic Age Acceleration (PhenoAgeAccel) score and the specific biological age-related biomarkers (glucose, mean corpuscular volume, white blood cell count and differential, creatinine, alkaline phosphatase, albumin, and lymphocyte percentage). Additional assessments will evaluate sleep quality, fatigue, energy, and health-related quality of life using the PROMIS Sleep Disturbance 8a, PROMIS Fatigue 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 include adverse events, vital signs, anthropometric measurements, and clinical laboratory assessments throughout the study.

The study aims to determine whether C15:0 supplementation can improve markers of RBC health and function while positively influencing biological aging-related pathways in healthy older adults.

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.