Recruiting

Early Nutrition

Sponsor:

Before Brands, Inc

Code:

NCT04803981

Conditions

Diet Diversity

Infant Nutrition

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

SpoonfulONE

Study Details

Brief 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

Study ID

NCT04803981

Start date

Apr 9, 2021

Status verified date

Apr, 2021

Completion date

Jul 1, 2023

Anticipated

Primary completion date

Jan 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Standard diet with daily SpoonfulONE

Participants will receive one serving of SO (one of three possible forms of SO: mix-ins, puffs, or crackers) daily in addition to a standard diet. The SO form fed on a given day will be at the discretion of the parent/guardian.

no intervention: Standard diet

Participants will feed on a standard diet only, with no intervention, and complete questionnaires

Interventions

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.

Primary outcome measure

  • Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 5 common foods (peanut, egg, cashew, cod, and sesame) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Claire Beard

919-660-5689claire.beard@duke.edu

Locations

Duke Clinical Research Institute

Recruiting

Durham, North Carolina, United States, 27701

More Information

Sponsor

Before Brands, Inc

Last update posted

Apr 13, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Before Brands, Inc on 2021-04-13.