NCT04803981

Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: Before Brands, Inc · Industry
• Sex: All
• Age: 4 Months – 6 Months
• Healthy volunteers: Accepted

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.

Conditions

• Diet Diversity
• Infant Nutrition

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-04-09
• Primary completion: 2023-01-01
• Completion: 2023-07-01
• First posted: 2021-03-18
• Last updated: 2021-04-13

Locations

1 site across 1 country: United States