The women’s health brand is looking to build the evidence base with a clinical trial of its Essential Postnatal supplement in breastfeeding women, reporting differences in maternal nutrient status and breast milk composition compared with placebo.
Among the findings was a 23% difference in levels of 3-fucosyllactose (3-FL), a human milk oligosaccharide (HMO), between the supplement and placebo groups. While the study did not assess what that difference might mean for infant health, the finding raises questions about the relationship between maternal nutrition and HMO composition.
“When we set out to build the product, we realized just how big the research gap was, especially when it came to the impact of supplementation on breast milk quality,” Katerina Schneider, founder and CEO of Ritual, told NutraIngredients.
For Schneider, the interest is also personal: after giving birth to three daughters, she saw a disconnect between the attention given to prenatal nutrition and the options available to women after pregnancy.
“Many women either keep taking their prenatal, which isn’t formulated for the specific demands of postpartum, or stop taking a multivitamin altogether,” she said.
What showed up in the milk
The 10-week randomized, double-blind, placebo-controlled trial enrolled 71 women, as detailed in its ClinicalTrials.gov registration, with Ritual reporting that 64 completed the study.
Participants began the trial approximately five weeks postpartum and received either the investigational postnatal supplement or placebo.
Ritual reported 106% higher biotin and 26% higher DHA in breast milk in the supplement group compared with placebo. In maternal blood, biotin was 97% higher and total folate was 35% higher.
But it was the 3-FL result that caught the company’s attention.
HMOs are naturally occurring components of human milk that are being increasingly studied for their relationship with the infant gut microbiome and immune development. “HMO levels have traditionally been viewed as governed largely by maternal genetics,” said Dr. Mastaneh Sharafi, senior vice president of scientific and clinical affairs at Ritual.
“Emerging research suggests maternal diet may influence the HMO profile of breast milk, but less is known about whether specific vitamins and minerals can do the same,” she added.
While Dr. Sharafi cautioned that the study alone cannot answer that question, she said the finding instead adds to a limited area of research into nutritional factors and HMO variability.
Putting the finished product on trial
The research also fits into Ritual’s wider bet on finished-product substantiation.
“Ingredient-level evidence tells you what a single nutrient can do on its own, often in a different population, in a different context than how it’s actually being used,” Dr. Sharafi said.
“When nutrients are combined, the result isn’t always the sum of their individual effects,” she added.
That approach comes with a trade-off: she explained that testing the full formulation may better reflect real-world product use, but it also means the researchers cannot tease out which nutrient or combination of nutrients was associated with each finding.
Ritual has committed more than $5 million to clinical studies on its finished products by 2030, and Schneider believes that investment should become more commonplace across the sector.
“I’m thrilled more products are getting clinically studied, but it should be the baseline, not a differentiator,” she said.
The bigger question comes next
The relatively small sample and 10-week duration leave plenty of room for follow-up. Dr. Sharafi said a longer study would be needed to capture some slower-turnover nutrients, while a different trial design would be required to determine whether any of the differences observed in breast milk have relevance for infants.
“The next step is connecting that shift to infant health outcomes directly, which requires a trial purpose-built and powered for that question,” she said.
Researchers at Brooklyn College of the City University of New York (CUNY) conducted the study in collaboration with researchers from Maimonides Medical Center. Dr. Xinyin Jiang served as principal investigator.
Ritual co-funded the trial with Mara Renewables/Algarithm and Kappa Bioscience, a Balchem company. The investigational formulation contained DHA manufactured by Algarithm and K2Vital MK-7 manufactured by Kappa Bioscience.
At the time of publication, NutraIngredients has reviewed the registered clinical trial protocol and study design but has not received the complete study data. Ritual has been contacted for further information on whether the findings will be submitted for publication in a peer-reviewed journal.
