Nara Organics is clinically studied and clinically proven.
We ran a 12+ month, double-blind clinical trial. Here's why that matters for your baby.
Why a clinical trial matters so much.
A clinical trial is a rigorous, independent scientific study that tests whether a new formula is safe for babies and supports healthy growth in infants. It's the gold standard for proving a formula performs — not just on paper, but in real life.
Nara Organics is the first USDA organic whole milk infant formula to complete its own clinical trial. A clinical trial is not standard practice, even for some brands that are new to the formula industry. It was our choice because we believe your baby deserves nothing less.
Here’s how we conducted our clinical study.
Nara's trial was randomized and double-blind, meaning neither the families nor the researchers knew which formula babies were receiving. That removes bias and makes the results trustworthy.
- 12+ months of study
- 176 babies enrolled
- 1st USDA organic whole milk formula to complete a clinical trial
What Nara’s clinical trial found.
Our independent, double-blind randomized controlled trial showed that Nara Organics Whole Milk Infant Formula:
- Is safe for babies
- Supports healthy growth
- Is well-tolerated — meaning babies digest it comfortably
Here's a look at the data:
Clinically Studied for Growth and Safety in Healthy Term Infants
Findings
No statistical difference between the Nara Organics formula and the Control formula with respect to the primary endpoints. It was demonstrated that Nara Organics formula supports normal physical growth in healthy term infants when fed as the sole source of nutrition.
Primary & Secondary Outcomes
At-home growth parameters measured as weight, weight-gain velocity, length, length-gain velocity, head circumference (HC), HC-gain velocity, weight-for-age, length-for-age, and HC-for-age Z-scores, weight-for-length Z-scores, all during a 16 week period.
Energetic Efficiency (per g Fat) of Nara Organics Whole Milk Infant Formula
Findings
The main difference between the two formulas is the fat content. Energetic Efficiency (EE) for weight gain was determined based on the fat content of the formulas (expressed as g/g Fat). Similar to the EE for weight, the EE for weight per g fat for the Nara ORganics formula was always higher in comparison with the COntrol formula at all time points.
We had to change the rules before we could even start.
Before Nara could run an infant formula clinical trial, we had to apply to the FDA for a GRAS in order to use the level of whole cows’ milk we wanted for our infant formula, the highest amount used in the U.S. today.
GRAS stands for "Generally Recognized as Safe.” Every ingredient in infant formula must have one permitting its use in the infant formula. When Esther set out to create Nara, she wanted to use only whole milk — no skim. But at the time, whole milk wasn't permitted as a formula ingredient in the U.S. There was no GRAS for it.
In 2021, Nara filed a GRAS application to use the highest level of whole cows’ milk in U.S. infant formula history. Today, multiple formula brands can use Nara’s approved GRAS to include whole milk in their own formulations. We believe a rising tide lifts all babies.
How most infant formula is developed.
Many new formula brands don't conduct their own clinical trials — and that's worth understanding.
The most common path is this: To save time and money, a brand licenses an existing formula recipe from a large manufacturer, applies their own branding, and relies on that manufacturer's clinical trial data, which can be years or even decades old (and may not even be on the same formulation that they intend to sell). Another approach is to make small modifications to an existing recipe without crossing the threshold requiring a new trial.
Clinical trials are expensive, time-consuming, and extremely rigorous. They take years to conduct and analyze. The fastest way for a brand to launch a new formula is to skip the clinical trial and launch an existing recipe that’s owned by a manufacturer, not the brand.
But here's what that means in practice: Many formulas that appear new aren’t truly new.
Nara was built from scratch. A genuinely new formula requires a genuinely new clinical trial. That was never a question for Esther and our team — it was a requirement.
Clinically studied. Truly whole milk. Built for your baby.
Esther could have taken a shortcut. She could have used an existing recipe, saved years of development time, and avoided the complexity of a clinical trial entirely. Many brands do. She didn't. Nara wasn't built to be another formula, it was built to be a better one. And that required doing the work.
We'll always go the extra mile for your baby. Clinical trial included.
