Diet DiversityINTENTNCT04803981
Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)
A study testing SpoonfulONE in people with Diet Diversity and Infant Nutrition, run by Before Brands, Inc at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 4 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Diet Diversity, Infant Nutrition
- What is being tested?
- SpoonfulONE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2021to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female 4-6 months of age at time of consent
- Provision of signed and dated informed consent form parent/guardian(s)
- Parent/guardian(s) stated willingness to introduce within 12 months and feed the participant 5 common foods, including peanuts, cashew, egg, sesame, and cod
- In good general health as evidenced by medical history reported by the parent/guardian(s)
- No known allergy to any of the ingredients in the study intervention (SO), their components, or excipients
Who cannot join
- Known physician confirmed allergies to any of the ingredients in SO at the time of consent
- Gastroesophageal reflux disease (GERD) diagnosed by a physician and requiring treatment (i.e., pharmacological and/or non-pharmacological treatments such as a wedge)
- Participant or parent/guardian unsuitable for the study, at the discretion of the investigator
- Sibling in the home is already enrolled in the study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Duke Clinical Research Institute
Durham, North Carolina, 27701
Claire Beard
About this study
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
- Being tested
- SpoonfulONE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpoonfulONEOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard diet with daily SpoonfulONE | Experimental | 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. Receives: Other: SpoonfulONE |
| Standard diet | No intervention | Participants will feed on a standard diet only, with no intervention, and complete questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Secondary outcomes (7)
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
Measured: Baseline
Diet diversity, score
Diet diversity score measured through regular questionnaires where participants will indicate which foods they are eating
Measured: 12 months
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
Measured: 12 months
Convenience, score through a questionnaire
Convenience of using daily SpoonfulONE, measured through a questionnaire
Measured: 12 months
Proportion of participants compliant to daily feeding protocols, measured through a questionnaire
Proportion of participants compliant to daily feeding protocols, measured through a questionnaire
Measured: 12 months
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
Measured: 12 months and 18 months
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
Measured: 12 months and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start9 Apr 2021
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet DiversityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Before Brands, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803981
- Sponsor's protocol ID
- SF-003
- Acronym
- INTENT
- Status last verified
- Apr 2021
- First submitted
- 15 Mar 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)
- ClinicalTrials.gov ID
- NCT04803981
- Acronym / sponsor ID
- INTENT / SF-003
- Conditions
- Diet Diversity, Infant Nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Before Brands, IncIndustry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard diet with daily SpoonfulONE | Experimental | Other: SpoonfulONEParticipants 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. |
| Standard diet | No intervention | –Participants will feed on a standard diet only, with no intervention, and complete questionnaires |
Who may qualify
- Ages
- 4 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female 4-6 months of age at time of consent
- Provision of signed and dated informed consent form parent/guardian(s)
- Parent/guardian(s) stated willingness to introduce within 12 months and feed the participant 5 common foods, including peanuts, cashew, egg, sesame, and cod
- In good general health as evidenced by medical history reported by the parent/guardian(s)
- No known allergy to any of the ingredients in the study intervention (SO), their components, or excipients
Key exclusion criteria (4 listed)
- Known physician confirmed allergies to any of the ingredients in SO at the time of consent
- Gastroesophageal reflux disease (GERD) diagnosed by a physician and requiring treatment (i.e., pharmacological and/or non-pharmacological treatments such as a wedge)
- Participant or parent/guardian unsuitable for the study, at the discretion of the investigator
- Sibling in the home is already enrolled in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpoonfulONESpoonfulONE 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. | Other | Standard diet with daily SpoonfulONE |
Primary outcome
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
Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 5 common foods (peanut, egg, cashew, cod, and sesame)
7 secondary outcomes
Parent/guardian comfort level of introducing food proteins into the participant's diet, Likert score
Time frame: Baseline
Diet diversity, score
Time frame: 12 months
Mean age of participants when first introduced to various food groups, measured through a questionnaire
Time frame: 12 months
Convenience, score through a questionnaire
Time frame: 12 months
Proportion of participants compliant to daily feeding protocols, measured through a questionnaire
Time frame: 12 months
Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 9 common food groups
Time frame: 12 months and 18 months
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
Time frame: 12 months and 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpoonfulONE in people with Diet Diversity and Infant Nutrition, run by Before Brands, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire Beard (919-660-5689, claire.beard@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.