We are researching the growth of babies who are only formula fed, based on weight, length and head circumference measurements during the first few weeks of their life.
We are looking for pregnant women and parents of babies less than 14 days old, who are planning to exclusively formula feed their new born.
Why Should you Participate?
We are looking for pregnant women and parents of babies less than 14 days old, who are planning to exclusively formula feed their new born.
We will provide our plant-based formula or commercial dairy-based brand formula.
A qualified nurse will come to your home once a month to weigh and measure your baby.
Keep track of how much formula your baby drinks.
Once your baby is born, we will schedule your first home visit with one of our nurses, which must be done within 14 days of birth. During these visits, a nurse will measure your baby’s weight, length and head circumference. You will be randomly selected to receive our plant-based formula or a commercial dairy-based brand formula, which will be shipped to your home within 1-2 days. You will need to exclusively feed your baby the study formula provided for the duration of the 12 week study. One of our nurses will come to your home every 2-4 weeks and more formula will be shipped to you after each visit.
Else Nutrition is whole plant nutrition, designed to support growth and development in babies.
Born from nature and backed by science, our mission is to provide your little ones with a real choice: the clean, whole-plant based alternative to dairy and soy-based nutrition, so you can feed with confidence. Else Nutrition has a full line of baby cereal as well as toddler and kid's nutrition products to support healthy eating at any developmental stage.
From the beginning, our mission has been to provide a plant-based, healthy alternative to dairy based formulas.
The purpose of this study is to evaluate the growth of healthy-term infants while consuming a plant-based infant formula. This is a comparative study in which some participants will receive a plant-based study formula while others will receive a commercial dairy-based formula , at no cost for the duration of the study.
We have been hard at work developing a dairy-free infant formula, and in order to bring it to market, we need to conduct this growth study as required by the FDA.
To be eligible for this study you must meet the following criteria:
Live in one of these cities:
Eligibility Conditions:
What are we researching?
We are researching the growth of babies who are only formula fed, based on weight, length and head circumference measurements during the first few weeks of their life.
What are you going to measure on my baby?
We will measure your baby’s weight, head circumference and length. These will be done over 6 visits.
What risks does this study have?
Our study protocol has been reviewed by top key opinion pediatricians and approved by the FDA. Your child may not like the formula or may have an allergy from the formula. There are risks with any study. These risks are outlined in your informed consent form.
What if the formula I am given doesn’t agree with my baby, can I switch?
Once you enter the study, the formula your baby is given cannot be switched. If the formula does not agree with your baby, you may withdraw from the study - keep in mind, little tummies need time to adjust to new foods.
Do you need to see my baby's medical records?
To confirm if your baby can participate in this study, the study staff needs to see your baby’s medical records from the hospital prior to your first visit. We need to confirm that your baby has been seen by a licensed doctor, your baby is not a twin, confirm the gestational age, understand any medications your baby may have received and your baby’s measurements at birth.
What is difference between Else and other formulas?
Else is a plant-based alternative infant formula, made from buckwheat and almonds. It is dairy free, soy-free, GMO-free and gluten free. It is used as an alternative to dairy-based formulas.
This study is IRB approved and
listed on clinicaltrials.gov
This study is sponsored by Else Nutrition
2022 Else Nutrition.