LOS ANGELES--(BUSINESS WIRE)--ChromaDex Corp. (NASDAQ:CDXC) announced today the initiation of a human clinical trial of Niagen® (nicotinamide riboside, or NR) investigating its potential to increase milk production among preterm mothers. This new human trial follows promising preclinical results which showed NR supplementation benefited both mother and newborn animals. The double-blinded study will compare mothers’ levels of milk production and other markers of metabolism between the experimental and control periods, respectively.
A study published in Cell Reports in 2019 reported that NR supplementation significantly increased milk production among rodent mothers with newborns, and promoted maternal weight loss following delivery. NR was also found to increase levels of a brain-growth promoting molecule called BDNF (brain-derived neurotrophic factor) in the milk, which translated to lasting improvements in coordination, strength, and learning capacity among the offspring of NR-supplemented mothers.
These findings paved the way for the clinical trial on NR and milk production just launched at the University of California, Davis. The trial will enroll 32 participant mothers who deliver preterm babies in the neonatal intensive care unit (NICU). These mothers will either receive NR for 7 days, followed by placebo for 7 days, or the opposite combination (known as a cross-over study).
“The lactation-promoting effects of NR that were observed in rodents were encouraging, and we are eager to see if they can be translated to human mothers and their children,” says Dr. Bruce German, lead investigator, professor at the Department of Food Science & Technology at the University of California, Davis, and member of ChromaDex’s Scientific Advisory Board. “Adequate breast milk production can be particularly life-saving among mothers of preterm infants, and our team lead by Erin Ford hope to generate promising data on this high-risk population.”
“This study will build upon the 11 published and over 40 ongoing human trials involving NR,” said Dr. Andrew Shao, Senior Vice President of ChromaDex Global Regulatory & Scientific Affairs. “We are committed to expanding upon the many promising preclinical and clinical findings to better understand NR’s myriad of health benefits.”
ChromaDex has invested over $35 million in investigating and marketing NR as Niagen, which has received regulatory acceptance in the United States, Canada, the European Union, and Australia.
This new study is being conducted through the ChromaDex External Research Program (CERP), which provides researchers with materials and data to facilitate scientific innovation. CERP announced its 200th research agreement earlier this year.
For additional information on ChromaDex, please visit www.chromadex.com.
ChromaDex Corp. is a science-based integrated nutraceutical company devoted to improving the way people age. ChromaDex scientists partner with leading universities and research institutions worldwide to discover, develop and create solutions to deliver the full potential of NAD and its impact on human health. Its flagship ingredient, NIAGEN® nicotinamide riboside, sold directly to consumers as TRU NIAGEN®, is backed with clinical and scientific research, as well as extensive IP protection. TRU NIAGEN® is helping the world AGE BETTER®. ChromaDex maintains a website at www.chromadex.com to which ChromaDex regularly posts copies of its press releases as well as additional and financial information about the Company.
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, including statements related to whether Niagen® can improve milk production in preterm mothers, whether Niagen® can increase levels of a brain-growth promoting molecule called BDNF, whether preclinical lactation-promoting effects of NR can be translated to human mothers and their children, and the timing and results of preclinical and clinical trials. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as "expects", "anticipates", "intends", "estimates", "plans", "potential", "possible", "probable", "believes", "seeks", "may", "will", "should", "could" or the negative of such terms or other similar expressions. More detailed information about ChromaDex and the risk factors that may affect the realization of forward-looking statements is set forth in ChromaDex's Annual Report on Form 10-K for the fiscal year ended December 31, 2019 as amended, ChromaDex's Quarterly Reports on Form 10-Q and other filings submitted by ChromaDex to the SEC, copies of which may be obtained from the SEC's website at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement and ChromaDex undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.