Skip to main content
Evidence-Based Supplement Research
Evidence-Based Supplement Research

Study Design

Type
Randomized Controlled Trial (RCT)
Population
Five healthy men
Methods
Pilot dose-escalation study; five healthy men consumed a standardized breakfast, then control (wheat flour) or low, medium, or high doses of supplements; blood drawn at 0, 1, 2, and 4 hours after the supplement; plasma concentrations and macrophage assays.
Duration
4 hours
Funding
Unclear
This pilot dose-escalation study evaluated the absorption and metabolism of a novel fasting mimetic formulation containing spermidine, nicotinamide, palmitoylethanolamide (PEA), and oleoylethanolamide (OEA) taken as oral supplements in young adults. Five healthy men consumed a standardized breakfast, followed by control (wheat flour) or low, medium, or high doses of supplements containing spermidine, nicotinamide, PEA, and OEA 2 hours later. Blood was drawn at 0, 1, 2, and 4 hours after the supplement (2, 3, 4, and 6 hours postprandial). Plasma concentrations of spermidine, 1-methylnicotinamide, PEA and OEA were quantified by liquid chromatography-mass spectrometry. The secretion of tumor necrosis factor alpha and production of reactive oxygen species by stimulated macrophages incubated with plasma, and cholesterol efflux capacity of plasma were analyzed. Plasma 1-methylnicotinamide, PEA, and OEA concentrations increased after supplement intake (P < .05). Spermidine concentrations decreased in the control arm (P < .05) but not the supplement arms. Net incremental area under the curve for tumor necrosis factor alpha and reactive oxygen species in stimulated macrophages decreased when incubated with plasma following supplement intake (P < .05). Intake of the combined supplements showed they were bioavailable and increased in plasma in a dose-dependent manner and provide preliminary data showing enhanced plasma anti-inflammatory and antioxidant functions. This trial was registered at clinicaltrials.gov (NCT05017428).

Research Insights

  • Plasma 1-methylnicotinamide, PEA, and OEA concentrations increased after supplement intake (P < .05).

    Effect
    Beneficial
    Effect size
    Small
    Dose
    low, medium, or high doses (specific doses not stated in abstract)
Back to top