Landmark IRB-approved study will compare methylfolate and folic acid head-to-head while tracking both biological markers and real-world reproductive outcomes

BOSTON, Sept. 15, 2026 /PRNewswire/ — FullWell, the reproductive wellness brand known for its evidence-based formulas founded by Registered Dietitian and fertility nutrition expert Ayla Barmmer, MS, RD, LDN, today announced the launch of FAMILIES (Folic Acid, Methylfolate & Infertility: Longitudinal Improvement & Experience Study), the first prospective, IRB-approved clinical study designed to isolate folate form as a single variable and evaluate how it impacts both blood folate biomarkers and reproductive outcomes.

Folate is one of the most important nutrients in prenatal nutrition—and one of the most debated. For years, consumers and healthcare practitioners have faced conflicting information about methylfolate and folic acid, with limited clinical data directly comparing the two forms in a controlled setting. While mechanistic evidence and decades of dietary and supplemental methylfolate exposure exist, no prospective study has isolated folate form as the sole differentiator while tracking both fertility and pregnancy outcomes.

FAMILIES was designed to answer that question.

Sponsored by FullWell and conducted by independent research organization People Science, Inc., the study will enroll 120 women across the United States, with a target of 100 evaluable participants. Eligible participants are healthy women with male partners who have been trying to conceive naturally for less than six months and have no diagnosed reproductive conditions.

Participants will be randomized into one of two groups receiving otherwise identical prenatal formulations:

• A methylfolate-based prenatal providing folate as 5-MTHF, the bioactive form used directly by the body
• A folic acid-based prenatal providing folate as folic acid, the conventional synthetic form that requires conversion before use

Researchers will evaluate changes in blood biomarkers, time to conception, conception rates, pregnancy progression, and participant-reported experiences over a study period of up to 72 weeks. Because women don’t experience reproductive health in isolated phases, neither should the research. FAMILIES was designed to follow participants through the reproductive journey—from trying to conceive through pregnancy, and potentially postpartum—to better understand how folate form may impact outcomes.

While prenatal supplement studies have become increasingly common, many are designed to evaluate the performance of a finished product. FAMILIES was built from a different starting point.

“Our research approach starts with two simple questions: what are clients asking in practice, and what do practitioners actually want to know?” said Ayla Barmmer, MS, RD, LDN, founder of FullWell and designated lead author of the study. “The methylfolate versus folic acid question has been coming up for years. We created FAMILIES to answer that question head-on. This is the kind of research we believe women’s health deserves, and we’re committed to sharing the findings regardless of what they show.”

For clinicians, answering that question has implications that extend well beyond a single nutrient comparison.

“As an OB/GYN, I know firsthand how wide the gap is between what we know and what we can confidently tell patients—and the folate question sits right in the middle of it,” said Carla Williams, MD, FACOG. “FAMILIES is designed to close that gap with the kind of independent, transparent, outcome-focused research that makes a real difference in clinical care, generating data that will help women and providers make better-informed decisions for years to come.”

The study’s principal investigator is Azure Grant, Ph.D., of People Science, Inc., with Noah Craft, M.D., Ph.D., and Marie Crisel Erfe, M.D., serving as sub-investigators.

The study reflects FullWell’s broader commitment to advancing women’s health through purposeful formulation and radical transparency. As part of that commitment, FullWell will share the complete findings from FAMILIES regardless of outcome, helping practitioners, researchers, and families make more informed decisions about reproductive nutrition.

Media Contact:
Sarah Raimo
sarah@teambreakpoint.com 

About FullWell
FullWell is a reproductive wellness company founded by Ayla Barmmer, MS, RD, LDN, a registered dietitian with advanced training in integrative and functional medicine, and 20+ years in clinical practice specializing in fertility nutrition. Committed to setting new standards for supplement quality and safety, FullWell is the only RD-founded and formulated brand built to positively impact generational health and longevity, creating clinically backed, evidence-based products that support reproductive health and fertility for both men and women. From everyday health and preconception support, to comprehensive nourishment for pregnancy, postpartum, perimenopause and beyond, FullWell empowers women and their partners at every stage of their reproductive journey. For more information, visit fullwellfertility.com and follow @fullwellfertility on Instagram.

View original content to download multimedia:https://www.prnewswire.com/news-releases/fullwell-launches-first-of-its-kind-study-to-answer-a-longstanding-folate-question-and-advance-the-future-of-womens-health-research-302878482.html

SOURCE FullWell