Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)

Infant Nutrition Clinical Trial

— INTENT  

Official title:

Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04803981
• Other study ID #: SF-003
• Status: Recruiting
• Phase: N/A
• Start date: April 9, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: April 2021
• Source: Before Brands, Inc
• Contact: Claire Beard
• Phone: 919-660-5689
• Email: claire.beard[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, controlled, open-label, pragmatic, direct-to-participant trial designed for infants. The study will be conducted using a mobile application platform to engage parents with healthy infants and parents with infants with eczema in introducing complementary feeding in line with new feeding guidelines for diet diversity, gather parental experiences of feeding, support early introduction of different food proteins and support feeding of SpoonfulONE.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: July 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months to 6 Months

Eligibility

Inclusion Criteria:

1. Male or female 4-6 months of age at time of consent

2. Provision of signed and dated informed consent form parent/guardian(s)

3. Parent/guardian(s) stated willingness to introduce within 12 months and feed the participant 5 common foods, including peanuts, cashew, egg, sesame, and cod

4. In good general health as evidenced by medical history reported by the parent/guardian(s)

5. No known allergy to any of the ingredients in the study intervention (SO), their components, or excipients

Exclusion Criteria:

1. Known physician confirmed allergies to any of the ingredients in SO at the time of consent

2. Gastroesophageal reflux disease (GERD) diagnosed by a physician and requiring treatment (i.e., pharmacological and/or non-pharmacological treatments such as a wedge)

3. Participant or parent/guardian unsuitable for the study, at the discretion of the investigator

4. Sibling in the home is already enrolled in the study

Related Conditions & MeSH terms

• Diet Diversity
• Infant Nutrition

Intervention

Other:
• SpoonfulONE
SpoonfulONE is a line of nutritional food products designed to help improve diet diversity starting in early infancy. SpoonfulONE covers a wide range of food proteins. Each product contains 30 mg of peanuts, milk, shellfish (shrimp), tree nuts (almond, cashew, hazelnut, pecan, pistachio, and walnut), egg, fish (cod and salmon), grains (wheat and oat), soy, and sesame.

Locations

Country	Name	City	State
United States	Duke Clinical Research Institute	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Before Brands, Inc	Duke Clinical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 5 common foods (peanut, egg, cashew, cod, and sesame)	Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 5 common foods (peanut, egg, cashew, cod, and sesame)	12 months
Secondary	Parent/guardian comfort level of introducing food proteins into the participant's diet, Likert score	Parent/guardian comfort level of introducing food proteins into the participant's diet, Likert score	Baseline
Secondary	Diet diversity, score	Diet diversity score measured through regular questionnaires where participants will indicate which foods they are eating	12 months
Secondary	Mean age of participants when first introduced to various food groups, measured through a questionnaire	Mean age of participants when first introduced to various food groups, measured through a questionnaire	12 months
Secondary	Convenience, score through a questionnaire	Convenience of using daily SpoonfulONE, measured through a questionnaire	12 months
Secondary	Proportion of participants compliant to daily feeding protocols, measured through a questionnaire	Proportion of participants compliant to daily feeding protocols, measured through a questionnaire	12 months
Secondary	Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 9 common food groups	Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 9 common food groups	12 months and 18 months
Secondary	Proportion of participants on SpoonfulONE compared to the proportion of participants on the non-intervention arm who tolerated each individual food groups of the 9 selected food groups, measured through a questionnaire	Proportion of participants on SpoonfulONE compared to proportion of participants on the non-intervention arm who tolerated each individual food groups of the 9 selected food groups, measured through a questionnaire	12 months and 18 months