Effect of Pentadecanoic Acid Supplementation on Red Blood Cell Health and Biological Aging in Healthy Older Adults
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55+
SponsorReCellience15, Inc
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pentadecanoic Acid
Dietary supplementPentadecanoic 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
Other interventionPlacebo 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.
Treatment groups
93 Participants
are divided into 3 treatment groupsGroup A: Pentadecanoic Acid (200 mg/day)Experimental treatment 1 intervention
Group B: Pentadecanoic Acid (300 mg/day)Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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
Time frame
Change from baseline at Week 12Secondary outcomes
1
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
Time frame
Change from baseline at Week 62
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
Time frame
Change from baseline at Week 6 and Week 123
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
Time frame
Change from baseline at Week 6 and Week 124
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
Time frame
Change from baseline at Week 6 and Week 12Other outcomes
1
To assess heart rate for safety
Heart rate (bpm) is assessed for safety of the TP
Time frame
From baseline to Week 122
To assess blood pressure for safety
Blood pressure (mmHg) assessed for safety of the TP
Time frame
From baseline to Week 123
To assess weight for safety
Weight (kg) is assessed for safety of the TP
Time frame
From baseline to Week 124
To assess body mass index for safety
Body Mass Index (kg/m2) is assessed for safety of the TP
Time frame
From baseline to Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
ReCellience15, Inc
Lead sponsor
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Collaborator
Source ClinicalTrials.gov
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