Biological Aging, Healthy Aging, Red Blood Cell Health
Conditions
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
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.
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.
Interventions
DIETARY_SUPPLEMENTPentadecanoic 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.
OTHERPlacebo
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.
Sponsors
ReCellience15, Inc
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 at Week 12 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate early changes in RBC health at two dose levels, as measured by RDW, compared to placebo | Change from baseline at Week 6 | Change from baseline in RDW-CV (%) at Week 6, adjusted for baseline RDW, comparing each active dose to placebo |
| 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 | Change from baseline in CRP (mg/L) at Week 6 and Week 12 comparing each active dose to placebo |
| 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 | Change from baseline in hemoglobin (g/dL) at Week 6 and Week 12 comparing each active dose to placebo |
| 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 | Change from baseline in hematocrit (%) at Week 6 and Week 12 comparing each active dose to placebo |
| 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 | Change from baseline in RBC count (10¹²/L) at Week 6 and Week 12 comparing each active dose to placebo |
| To evaluate the effect of the TP at two dose levels on circulating C15:0 fatty acid concentrations compared to placebo | Change from baseline at Week 12 | Change from baseline in plasma C15:0 levels and erythrocyte membrane fatty acid composition at Week 12 comparing each active dose to placebo |
| To evaluate the effect of the TP at two dose levels on RBC metabolism markers compared to placebo | Change from baseline at Week 12 | Change from baseline in reticulocytes at Week 12 comparing each active dose to placebo |
| To evaluate the effect of the TP at two dose levels on markers of iron status compared to placebo | Change from baseline at Week 12 | Change from baseline in serum iron at Week 12 comparing each active dose to placebo |
| To evaluate the effect of the TP at two dose levels on biological age-related biomarkers compared to placebo | Change from baseline at Week 12 | Change from baseline in glucose at Week 12 comparing each active dose to placebo |
| To evaluate the effect of the TP at two dose levels on biological aging | Change from baseline at Week 12 | Change from baseline in Phenotypic Age Acceleration (PhenoAgeAccel) at Week 12 comparing each active dose to placebo |
| To evaluate the effect of the TP at two dose levels on sleep quality compared to placebo | Change from baseline at Week 12 | Change from baseline in PROMIS Sleep Disturbance 8a at Week 12 comparing each active dose to placebo |
| To evaluate the effect of the TP at two dose levels on energy compared to placebo | Change from baseline at Week 12 | Change from baseline in PROMIS Fatigue 8a at Week 12 comparing each active dose to placebo |
| To evaluate the effect of the TP at two dose levels on health-related quality of life compared to placebo | Change from baseline at Week 12 | Change from baseline in RAND-36 at Week 12 comparing each active dose to placebo |
Countries
Canada
Contacts
CONTACTJevaneeh Rubio
CONTACTStephanie Recker
STUDY_DIRECTORBruce Brown
ReCellience15, Inc
Outcome results
None listed