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

NCT07812792 | Not Yet Recruiting Phase 2

• 1 other identifier: R03-26-01-T0099
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Red Blood Cell Health; Biological Aging; Healthy Aging

Keywords

Pentadecanoic Acid (C15:0); Red Blood Cell Health; Red Blood Cell Distribution Width (RDW); Biological Aging; Healthy Aging; Healthy Older Adults; C-Reactive Protein (CRP); Inflammation

Outcome Measures

Primary Outcomes (1)

• To assess the effect of the test product (TP) at two dose levels on red blood cell (RBC) health, as measured by red blood cell distribution width (RDW), compared to placebo

  Change from baseline in RDW-CV (%) at Week 12, adjusted for baseline RDW, comparing each active dose (200 mg/day and 300 mg/day) to placebo

  Change from baseline at Week 12

Secondary Outcomes (23)

• To evaluate early changes in RBC health at two dose levels, as measured by RDW, compared to placebo

  Change from baseline at Week 6

• To assess the effect of the TP at two dose levels on systemic inflammation, as measured by C-reactive protein (CRP), compared to placebo

  Change from baseline at Week 6 and Week 12

• To evaluate the effect of the TP at two dose levels on hemoglobin levels compared to placebo

  Change from baseline at Week 6 and Week 12

• To evaluate the effect of the TP at two dose levels on hematocrit compared to placebo

  Change from baseline at Week 6 and Week 12

• To evaluate the effect of the TP at two dose levels on RBC count compared to placebo

  Change from baseline at Week 6 and Week 12

Other Outcomes (7)

• To assess the safety of the TP (Vitals)

  From baseline to Week 12

• To assess the safety of the TP (Vitals)

  From baseline to Week 12

• To assess the safety of the TP (Anthropometrics)

  From baseline to Week 12

Study Arms (3)

Pentadecanoic Acid (200 mg/day)

EXPERIMENTAL

Participants receive 200 mg/day pentadecanoic acid (C15:0) administered as three capsules daily (2 active capsules and 1 placebo capsule) for approximately 12 weeks.

Dietary Supplement: Pentadecanoic Acid

Pentadecanoic Acid (300 mg/day)

EXPERIMENTAL

Participants receive 300 mg/day pentadecanoic acid (C15:0) administered as three active capsules daily for approximately 12 weeks.

Dietary Supplement: Pentadecanoic Acid

Placebo

PLACEBO COMPARATOR

Participants receive three placebo capsules daily for approximately 12 weeks. Placebo capsules are matched to the active study product in appearance and packaging.

Other: Placebo

Interventions

Pentadecanoic Acid DIETARY_SUPPLEMENT

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.

Also known as: C15:0

Pentadecanoic Acid (200 mg/day); Pentadecanoic Acid (300 mg/day)

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ReCellience15, Inc: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (1)

Apex Trials

Guelph, Ontario - on, N1G 0B4, Canada

Location

MeSH Terms

Conditions

Inflammation

Interventions

pentadecanoic acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bruce Brown

  ReCellience15, Inc

  STUDY DIRECTOR

Central Study Contacts

Jevaneeh Rubio

CONTACT

519-341-3367; jrubio@nutrasource.ca

Stephanie Recker

CONTACT

519-341-3367; srecker@nutrasource.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 10, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)