Pancreas DiseaseNCT04559490
Baby Formula and Health
An observational study of Pancreas Disease, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to learn about how different types of carbohydrates used in infant formula may affect a baby's intestines and pancreas. Read more about this study
- Who is it for?
- Ages 5 months and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreas Disease
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2020to 16 Sep 2023
- Phase
- Observational
- 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 5 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Mothers and infants will be enrolled.
Who may be able to join
- Mothers ≥ 19 years of age
- Singleton birth
- Healthy Infants
- Infant between 3-6 months at the time of visit and exclusively fed one of the formulas for a minimum of 3 months
Who cannot join
- Delivery before 35 weeks
- Infant birth weight <2500g
- Infants exhibiting growth faltering (loss of more than 25 percentile points) between 1 month to the time of study visit for either weight or length.
- Infant medical or genetic indications that would impact normal feeding behavior, insulin signaling or growth patterns.
- Infant consumption of more than two servings of complementary foods per day before the study visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center of the University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Formula - Understanding Nutrition (FUN)
The purpose of this study is to learn about how different types of carbohydrates used in infant formula may affect a baby's intestines and pancreas.
- Conditions
- Pancreas Disease
- Medical subject headings
- Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Standard formula | Participants receiving intact protein lactose-based formula, exclusively for at least 3 months. | |
| Sensitive | Participants receiving intact protein glucose/sucrose- based formula, exclusively for at least 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean change in blood glucose
change in blood glucose from fasting to 1 hour post glucose challenge
Measured: baseline to 1 hour
Secondary outcomes (1)
mean endogenous insulin secretion
change in mean insulin collected at baseline and 1 hour post glucose challenge
Measured: baseline to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start16 Sep 2020
- Primary completion9 Jun 2022
- Study completion16 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas DiseaseStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bridget Young, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559490
- Sponsor's protocol ID
- STUDY00004724
- Status last verified
- Oct 2023
- First submitted
- 16 Sep 2020
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formula - Understanding Nutrition (FUN)
- ClinicalTrials.gov ID
- NCT04559490
- Acronym / sponsor ID
- STUDY00004724
- Conditions
- Pancreas Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 16 Sep 2023 (actual)
- First posted
- 23 Sep 2020 (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.
The purpose of this study is to learn about how different types of carbohydrates used in infant formula may affect a baby's intestines and pancreas.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard formula | – | –Participants receiving intact protein lactose-based formula, exclusively for at least 3 months. |
| Sensitive | – | –Participants receiving intact protein glucose/sucrose- based formula, exclusively for at least 3 months. |
Who may qualify
- Ages
- 5 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mothers and infants will be enrolled.
Key inclusion criteria (4 listed)
- Mothers ≥ 19 years of age
- Singleton birth
- Healthy Infants
- Infant between 3-6 months at the time of visit and exclusively fed one of the formulas for a minimum of 3 months
Key exclusion criteria (5 listed)
- Delivery before 35 weeks
- Infant birth weight <2500g
- Infants exhibiting growth faltering (loss of more than 25 percentile points) between 1 month to the time of study visit for either weight or length.
- Infant medical or genetic indications that would impact normal feeding behavior, insulin signaling or growth patterns.
- Infant consumption of more than two servings of complementary foods per day before the study visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mean change in blood glucose
Time frame: baseline to 1 hour
change in blood glucose from fasting to 1 hour post glucose challenge
1 secondary outcome
mean endogenous insulin secretion
Time frame: baseline to 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Disease, run by University of Rochester 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 4 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean change in blood glucose (time frame: baseline to 1 hour). 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 4 Oct 2023.