Infancy to Toddlerhood:
Early Nutrition & Tolerance Study
The Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT) Study is a clinical research study to learn if feeding small amounts of common food proteins to babies can affect diet diversity (eating different types of foods over time).
INTENT is a virtual study that will take place through a mobile app. The study will also help researchers learn more about introducing food to babies and parents’ experiences feeding their children.
Take the study screener now to see if your baby might be eligible to participate.
About The INTENT Study
The INTENT Study is taking place to learn more about how babies tolerate different types of common foods and whether feeding small amounts of common foods can affect diet diversity as babies get older. Researchers would also like to learn more about how parents feed their babies and how they feel about introducing common food proteins.
The study will involve two groups of babies.
One group will eat a daily serving of SpoonfulONE Mix-ins, Puffs, or Crackers along with their regular food. SpoonfulONE is a line of infant and toddler food products intended to train a child’s body to accept food as food rather than cause side effects.
The second group of babies will eat their regular food only.
Later in the study, parents in both groups will introduce five common foods (peanuts, cashew, egg, sesame, and cod) to their child’s diet.
Parents in both groups will answer questions on the mobile app monthly, every three months, and at the end of the study. The questions should only take between 5 and 10 minutes to complete. Study participation will last for up to 18 months.
Who Can Participate in the INTENT Study?
Your child may be able to take part if:
- He or she is 4 to 6 months of age on the day they start the study
- You agree to introduce five common foods, including peanuts, cashew, egg, sesame, and cod
- Your baby is in good general health
- Your baby has no known allergy to any of the ingredients in SpoonfulONE
Other Information about the Study
- All study participation will take place using the mobile app. No in-person visits will be required.
- All families who take part in the study will be compensated for their time. Study participation will involve completion of surveys and required tasks.
- There is no cost to participate in the study.
- Babies enrolled in the SpoonfulONE food group will receive free SpoonfulONE Mix-ins, Puffs, and Crackers delivered to their home.
- Parents will receive educational materials from pediatricians, dietitians, and allergists through the mobile app.
What is a Clinical Research Study?
Research studies play an important role in science and help doctors and scientists learn more about different healthcare related topics. Different types of studies all share a common purpose: to help people live healthier lives. Whether participating for a specific disease or as a healthy participant, your participation has a direct impact on advancing science.
Volunteers, or study participants, like you help make these advances in science possible. These studies are all monitored by regulatory organizations and reviewed by Institutional Review Boards (IRBs) to ensure the safety and interests of participants are protected.
Participation in research is always voluntary and people who decide to take part can choose to stop participating at any time.
What is a Virtual Study?
The INTENT Study is a virtual study which means that all study participation will happen through a mobile application you can download to your smartphone. No in-person study-related visits are required to take part in the study.
On the mobile application, parents will create a profile and answer questions about their experiences feeding their children. The mobile application will also provide educational materials from pediatricians, dietitians, and allergists. There is no fee to download the mobile application.
Given the virtual design of the study, it will be important for you to turn on notifications when prompted so the study team can share important updates and helpful information.
What is SpoonfulONE?
SpoonfulONE is a line of infant and toddler food products currently available in the form of Mix-ins, Puffs, and Crackers. SpoonfulONE products are intended to train your child’s body to accept food as food by including small amounts of a wide range of food proteins. These include peanuts, milk, shellfish, tree nuts, egg, finned fish, grains, soy, and sesame.
The goal of the INTENT Study is to learn how children who eat SpoonfulONE tolerate common food proteins after 12 and 18 months of feeding compared to children who do not.
Learn More
If you would like more information, please reach out to our study team using the form here.
Any future study participation is voluntary.
After learning more about the study, you can decide if you and your family would like to take part.
*Other eligibility participation requirements will apply and will be available on the mobile application.
Or, you can take the study screener now to see if your baby might be eligible to participate.
Study Partners
Our Team
Before Brands, Inc. is the sponsor of the study and the Duke Clinical Research Institute, which is part of Duke University, is coordinating study operations.
The Executive Advisory Committee is providing scientific guidance on the study design, execution, analysis, and digital design of the INTENT Study.
Principal Investigators
David Jeong, MD
Principal Investigator
Pediatrician and Allergist
Section Head, Virginia Mason Medical Center and Benaroya Research Institute
Christoph Hornik, MD, PhD
Duke Clinical Research Institute Principal Investigator
Assoc. Professor, Duke University
Chief, Division of Quantitative Sciences
Executive Advisory Committee
Drew Bird, MD
Director of the Food and Allergy Center at Children's Medical Center
Associate Professor, UT Southwestern Medical Center
Ruchi Gupta, MD, MPH
Director, Institute for Public Health and Medicine (IPHAM) - Center for Food Allergy & Asthma
Professor, Northwestern University School of Medicine
Susannah Fox
Healthcare and information technology researcher
Chief Technology Officer, US Department of Health and Human Services (2015-17)
Kari Nadeau, MD, PhD
SpoonfulONE Co-Founder
Director, Sean N. Parker Center for Allergy and Asthma Research at Stanford University
Endowed Professor, Stanford University School of Medicine
Edwin Kim, MD, MS
Study Consultant for DCRI
Director, UNC Food Allergy Initiative
Associate Professor, UNC
Carina Venter, PhD, RD
Chair, International Network of Dietitians and Nutritionists in Allergy
Associate Professor of Pediatric Allergy & Immunology at the University of Colorado School of Medicine
Dave Stukus, MD
Director, Food Allergy Treatment Center at Nationwide Children's Hospital
Associate Professor, Nationwide Children's Hospital and The Ohio State University College of Medicine
Before Brands Team
Wendy Sue Swanson, MD, MBE
Chief Medical Officer
Pediatrician
Alex Wei, PharmD
Medical Director
Jimmy Xu, PharmD
Manager, Medical and Digital Health
Learn More
If you would like more information, please reach out to our study team using the form here.
Any future study participation is voluntary.
After learning more about the study, you can decide if you and your family would like to take part.
*Other eligibility participation requirements will apply and will be available on the mobile application.
Or, you can take the study screener now to see if your baby might be eligible to participate.