It’s time to change perinatal nutrition research and the standard of care.
Needed Labs is scaling radically better clinical insights and research to change perinatal outcomes.
Nutrition changes perinatal outcomes.
Not just birth outcomes, but fertility, pregnancy, postpartum, and the health trajectory of mom and baby for the rest of their life, and future generations thereafter. This, however, is not widely understood, dispersed, or accepted.
Women, children, and future generations are paying a steep price.
Needed Labs is on a mission to develop new data through research and aggregate clinical insights to make sure:
That the impact of proper perinatal nutrition can no longer be ignored in the standard of care
Knowledge around perinatal nutrition stays at the cutting edge, including around evolving areas like epigenetics and the microbiome
Insights and Research
Why is perinatal nutrition research and the standard of care so broken?
1.Women have been largely absent from biomedical research. In 1977, the FDA issued a guideline banning most women of "childbearing potential" from participating in clinical research studies. This policy was formally rescinded in 1993. Nevertheless, women are still grossly underrepresented in research.
2.Government recommendations (Dietary Reference Intakes (DRIs), Recommendation Daily Allowance (RDAs) etc.) are considered the standard for nutrition recommendations. However, pregnant and breastfeeding women were only included in 17% of the studies which informed the nutrient reference values for these life stages. Study populations also lacked racial and ethnic diversity.
3.Both DRIs and RDAs represent guidelines for "nutrient adequacy", i.e. the minimum amount needed to avoid a deficiency. Yet optimal health is not simply the avoidance of deficiency or disease. Therefore, these values generally fail to reflect what it takes to be fully supported.
4.OB-GYNs are the care provider for 85%+ of births in the US. On average OB-GYNs need to see 30-40 patients per day at an average appointment time of 7 minutes to cover their overhead costs. There's no room for nutritional or preventative care in the current system.
5.There is a lag between research findings and official guidelines / the standard of care. On average this lag is 17 years from clinical research findings to clinical practice!
6.Once new research makes its way into guidelines, there is often a lag before it is widely reflected in leading prenatal vitamins.
7.Despite these lags, positive nutritional interventions are happening in the clinical practice of many practitioners throughout the US, but it is difficult to aggregate these insights at a large, research scale.
8.The historical gold standard for research (double-blind, placebo-controlled RCT) has inherent limitations in assessing complex systems like human health holistically and longitudinally. While insights from such studies are necessary, it is time to evolve research through new designs using digital tools and mirroring real world scenarios to unlock better outcomes, greater participant diversity, and optimize perinatal health research.
The current state of perinatal nutrition research
We know the perinatal nutrition paradigm is broken, and we’d like to state the evidence. As a cornerstone to its core mission, Needed Labs has pioneered a comprehensive analysis of the current state of research on perinatal nutrition.
Prenatal Nutrient Status Study
Needed has launched a foundational research study to better understand nutrient status among pregnant women taking a daily prenatal supplement. The study will take place across 6 diverse metropolitan areas in the United States and include 250 pregnant women.
Scaling a Proven Nutritional Care™ Model
Needed Labs is working to scale a proven Nutritional Care™ model in partnership with Growbaby Health that combines access to a perinatal nutritionist with personalized diet, supplement, and lifestyle recommendations grounded in nutritional biomarker and genetic testing. This proven care model has demonstrated over a decade of positive outcomes for maternal and infant health, including a less than 1% preterm birth rate (vs 10.5% in the general US pregnancy population), a 0.2% gestational diabetes rate (vs 8.31% in the general US pregnancy population), and 0.7% hypertension rate (vs 15.9% in the general US pregnancy population).
Sign up below to learn more about Needed Nutritional Care™, including our beta kicking off in 2024.
Join Our Research Efforts
We invite individual consumers, women’s health experts, the scientific community, and other mission-driven brands to join us in our efforts to change perinatal research and the standard of care. Join our mailing list to get involved.