Red Blood Cell HealthPhase 2NCT07812792
Effect of Pentadecanoic Acid Supplementation on Red Blood Cell Health and Biological Aging in Healthy Older Adults
A Phase 2 study testing Pentadecanoic Acid in people with Red Blood Cell Health and Biological Aging, run by ReCellience15, Inc at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Red Blood Cell Health, Biological Aging, Healthy Aging
- What is being tested?
- Pentadecanoic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2027to Jun 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Apex Trials
Guelph, Ontario - on, N1G 0B4
Ann Anton, 519-341-3366 ext. 120, aanton@apextrials.com
Mariya Chalaskanova, 519-546-5359, mchalashkanova@apextrials.com
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Red Blood Cell Health, Biological Aging, Healthy Aging
- Being tested
- Pentadecanoic Acid, Placebo
- 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
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentadecanoic AcidDietary supplement
Also called C15:0
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.
PlaceboOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 in RDW-CV (%) at Week 6, adjusted for baseline RDW, comparing each active dose to placebo
Measured: 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 in CRP (mg/L) at Week 6 and Week 12 comparing each active dose to placebo
Measured: 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 in hemoglobin (g/dL) at Week 6 and Week 12 comparing each active dose to placebo
Measured: 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 in hematocrit (%) at Week 6 and Week 12 comparing each active dose to placebo
Measured: 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 in RBC count (10¹²/L) at Week 6 and Week 12 comparing each active dose to placebo
Measured: Change from baseline at Week 6 and Week 12
To evaluate the effect of the TP at two dose levels on circulating C15:0 fatty acid concentrations compared to placebo
Change from baseline in plasma C15:0 levels and erythrocyte membrane fatty acid composition at Week 12 comparing each active dose to placebo
Measured: Change from baseline at Week 12
To evaluate the effect of the TP at two dose levels on RBC metabolism markers compared to placebo
Change from baseline in reticulocytes at Week 12 comparing each active dose to placebo
Measured: Change from baseline at Week 12
To evaluate the effect of the TP at two dose levels on RBC metabolism markers compared to placebo
Change from baseline in mean corpuscular hemoglobin concentration (MCHC) at Week 12 comparing each active dose to placebo
Measured: Change from baseline at Week 12
To evaluate the effect of the TP at two dose levels on markers of iron status compared to placebo
Change from baseline in serum iron at Week 12 comparing each active dose to placebo
Measured: Change from baseline at Week 12
To evaluate the effect of the TP at two dose levels on markers of iron status compared to placebo
Change from baseline in ferritin at Week 12 comparing each active dose to placebo
Measured: Change from baseline at Week 12
To evaluate the effect of the TP at two dose levels on markers of iron status compared to placebo
Change from baseline in transferrin saturation at Week 12 comparing each active dose to placebo
Measured: Change from baseline at Week 12
To evaluate the effect of the TP at two dose levels on biological age-related biomarkers compared to placebo
Change from baseline in glucose at Week 12 comparing each active dose to placebo
Measured: Change from baseline at Week 12
To evaluate the effect of the TP at two dose levels on biological aging
Change from baseline in Phenotypic Age Acceleration (PhenoAgeAccel) at Week 12 comparing each active dose to placebo
Measured: Change from baseline at Week 12
To evaluate the effect of the TP at two dose levels on biological age-related biomarkers compared to placebo
Change from baseline in mean corpuscular volume (MCV) at Week 12 comparing each active dose to placebo
Measured: Change from baseline at Week 12
To evaluate the effect of the TP at two dose levels on biological age-related biomarkers compared to placebo
Change from baseline in white blood cell (WBC) count + differential at Week 12 comparing each active dose to placebo
Measured: Change from baseline at Week 12
To evaluate the effect of the TP at two dose levels on biological age-related biomarkers compared to placebo
Change from baseline in creatinine at Week 12 comparing each active dose to placebo
Measured: Change from baseline at Week 12
To evaluate the effect of the TP at two dose levels on biological age-related biomarkers compared to placebo
Change from baseline in alkaline phosphatase (ALP) at Week 12 comparing each active dose to placebo
Measured: Change from baseline at Week 12
To evaluate the effect of the TP at two dose levels on biological age-related biomarkers compared to placebo
Change from baseline in albumin at Week 12 comparing each active dose to placebo
Measured: Change from baseline at Week 12
To evaluate the effect of the TP at two dose levels on biological age-related biomarkers compared to placebo
Change from baseline in lymphocyte % at Week 12 comparing each active dose to placebo
Measured: Change from baseline at Week 12
To evaluate the effect of the TP at two dose levels on sleep quality compared to placebo
Change from baseline in PROMIS Sleep Disturbance 8a at Week 12 comparing each active dose to placebo
Measured: Change from baseline at Week 12
To evaluate the effect of the TP at two dose levels on energy compared to placebo
Change from baseline in PROMIS Fatigue 8a at Week 12 comparing each active dose to placebo
Measured: Change from baseline at Week 12
To evaluate the effect of the TP at two dose levels on energy compared to placebo
Change from baseline in Energy Visual Analog Scale at Week 12 comparing each active dose to placebo
Measured: Change from baseline at Week 12
To evaluate the effect of the TP at two dose levels on health-related quality of life compared to placebo
Change from baseline in RAND-36 at Week 12 comparing each active dose to placebo
Measured: Change from baseline at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Red Blood Cell HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReCellience15, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Bruce Brown, Study director, ReCellience15, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812792
- Sponsor's protocol ID
- R03-26-01-T0099
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No