This study aims to evaluate the feasibility and effects of nicotinamide riboside (NR) supplementation in lactating mothers of infants expected to be hospitalized in the neonatal intensive care unit (NICU) for at least four weeks.
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Parallel
Nicotinamide Riboside (NR)
Other interventionMothers receive daily oral nicotinamide riboside chloride 250 mg supplementation per day for 14 days (+ 2 days extra capsule for loss or extending sample collection), from study Day 4 + 1 day \[D4-5\] to study Day 17 + 2 days \[D17-19\].
Placebo
Other interventionMothers receive a daily oral placebo, microcrystalline cellulose 250 mg per day matched in appearance and schedule to the nicotinamide riboside supplement for 14 days (+ 2 days extra capsule for loss or extending sample collection), from study Day 4 + 1 day \[D4-5\] to study Day 17 + 2 days \[D17-19\].
Feasibility of enrollment in a double-blind placebo-controlled supplementation trial in mothers of infants who are hospitalized.
Proportion of eligible mothers who consent to enrollment in the study.
Difference in mean milk volume of expressed milk (mL) between NR and placebo
Comparison of total 24-hour expressed breast milk volume (in milliliters) between mothers receiving nicotinamide riboside and those receiving placebo.
Difference in human milk micronutrient concentrations between NR and placebo over time.
Comparison of human milk micronutrient concentrations (Micrograms per liter (µg/L) or milligrams per liter (mg/L), depending on the element) between mothers receiving nicotinamide riboside and those receiving a placebo. Milk samples collected on study days will be analyzed using inductively coupled plasma mass spectrometry (ICP-MS) in a certified analytical laboratory.
Difference in amount and diversity of metabolites, including NAD+-related precursors and intermediates in milk between NR and placebo over time.
NMR metabolomics will be used to compare the amount and diversity of metabolites, including NAD⁺-related precursors and intermediates (e.g., nicotinamide riboside, nicotinamide mononucleotide, nicotinamide, NAD⁺) between the NR group and the placebo from the milk samples collected on various study days.
Difference in human milk glycans (HMOs, glycoproteins, glycolipids) between NR and placebo over time.
Comparison of human milk oligosaccharides (HMOs), glycoproteins, and glycolipids in milk samples collected on study days between NR and placebo groups using Nuclear magnetic resonance (NMR) spectroscopy-based metabolomics.
Change in maternal weight (lbs.)
This exploratory outcome measures change in maternal weight from baseline to the end of the study in participants receiving nicotinamide riboside versus placebo, measured using a calibrated digital scale at each study visit.
Outcome of growth parameters: Infant length (cm), weight(g), and head circumference ( cm).
This exploratory outcomes measure the changes in growth parameters (height, weight, and head circumference) using calculated z-scores (as measured by standard deviations from the mean, presented in percentages relative to the average for age).
NICU outcomes
NICU outcomes accessible in the EMR include morbidity, death, necrotizing enterocolitis, chronic lung disease, retinopathy of prematurity, and sepsis.
Difference in the concentration of urinary metabolites, including NAD+-specific metabolites as a proxy of NR supplementation, between NR and placebo over time.
Urinary metabolites will be measured using nuclear magnetic resonance (NMR)-based metabolomics between the nicotinamide riboside (NR) and placebo groups.
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University of California, Davis
Lead sponsor
ChromaDex, Inc.
Collaborator
