Linear GrowthNCT04137445
The Effects of Early Complementary Feeding on Growth, Neurodevelopment, Sleep and Gut Health
A study testing Baby Foods and Foods from the home in people with Linear Growth and Neurodevelopment, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The overall objective of this project is to understand how consuming a prescribed diet of different infant foods (which may contain cereals,fruits, vegetables, meats, dairy) during the time of early complementary feeding (~5 to 12 months) in breastfed infants has on growth trajectories, neurodevelopment and sleep… Read more about this study
- Who is it for?
- Ages 5 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Linear Growth, Neurodevelopment, Gut Microbiome
- What is being tested?
- Baby Foods and Foods from the home
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2020to Jun 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 5 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full term: gestational age > 37 weeks
- Exclusively breastfed (< 2 weeks of cumulative formula exposure). Any formula consumption on a given day is considered one day of formula exposure. During the intervention, if the participant receives more than 50% of the liquid diet from infant formula, s/he will be excluded from the study.
- Maternal conditions such as gestational diabetes mellitus, preeclampsia, multiple pregnancies are acceptable.
Who cannot join
- Large for gestational age or small for gestational age
- Antibiotic use from birth to the time of enrollment
- Documented food allergies
- Previous complementary food exposure
- Conditions that would affect protein metabolism or growth
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Minghua Tang, PhD, 303-724-3248, minghua.tang@ucdenver.edu
About this study
The overall objective of this project is to understand how consuming a prescribed diet of different infant foods (which may contain cereals,fruits, vegetables, meats, dairy) during the time of early complementary feeding (~5 to 12 months) in breastfed infants has on growth trajectories, neurodevelopment and sleep patterns in relation to gut microbiota, compared with a traditional diet that is usually provided in the home to infants.
The three primary aims include:
Read more
Aim 1: Identify the effects that the prescribed early complementary feeding specific study diet has on growth trajectories in breastfed infants.
Aim 2: Identify whether the relationship between the prescribed early complementary feeding specific study diet and growth is mediated by gut microbiota.
Aim 3: Characterize infant neurodevelopment and sleep patterns.
Read the detailed description
Some details are intentionally left to out to preserve the scientific integrity of the study, and they will be included in the record after the study is completed.
- Conditions
- Linear Growth, Neurodevelopment, Gut Microbiome
- Being tested
- Baby Foods, Foods from the home
- Keywords
- Complementary Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby FoodsOther
Commercially available baby foods
Foods from the homeOther
Caregiver will provide participant with usual foods from the home
| Study group | Role | What they receive |
|---|---|---|
| Study Provided Diet | Experimental | A group of complementary foods provided to participants by researchers. Receives: Other: Baby Foods |
| Traditional Diet | Placebo comparator | No study foods provided to participants by researchers. Participants will eat a typical diet provided by caregivers. Receives: Other: Foods from the home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured in kg
Measured: Over 6 months
Length
Measured in cm
Measured: Over 6 months
Gut Microbiome
Gut microbiota structure by 16S sequencing
Measured: Over 6 months
Secondary outcomes (11)
Neurodevelopment
Fine motor skills and cognition measured by the Bayley - III
Measured: At 12 months of age
Duration of sleep
Measured in minutes per 24 hours by the MicroMini-Motionlogger actigraph
Measured: Over 6 months
Body composition
Body fat mass, fat-free mass measured by stable isotopes
Measured: Over 6 months
Serum c-reactive protein (CRP-hs)
Measured in mg/L
Measured: Over 6 months
Serum IGF-1 (Insulin-like growth factor1/ somatomedin C)
Measured in ng/mL
Measured: Over 6 months
Serum IGFBP-3 (Insulin-like growth factor-binding protein 3)
Measured in ng/mL
Measured: Over 6 months
Dietary intake
3 day dietary recall with results generated by NDSR software
Measured: Over 6 months
Total calories in breast milk
Measured in kcal/100 mL
Measured: Over 6 months
Total carbohydrates in breast milk
Measured in g/100 mL
Measured: Over 6 months
Total protein in breast milk
Measured in g/100 mL
Measured: Over 6 months
Total fat in breast milk
Measured in g/100 mL
Measured: Over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start15 Mar 2020
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Linear GrowthStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Minghua Tang, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137445
- Sponsor's protocol ID
- 19-0546
- Other IDs
- R01DK126710
- Status last verified
- Feb 2023
- First submitted
- 17 Oct 2019
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Odiase E, Frank DN, Young BE, Robertson CE, Kofonow JM, Davis KN, Berman LM, Krebs NF, Tang M. The Gut Microbiota Differ in Exclusively Breastfed and Formula-Fed United States Infants and are Associated with Growth Status. J Nutr. 2023 Sep;153(9):2612-2621. doi: 10.1016/j.tjnut.2023.07.009. Epub 2023 Jul 26.
PubMed 37506974
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Early Complementary Feeding on Growth, Neurodevelopment, Sleep and Gut Health
- ClinicalTrials.gov ID
- NCT04137445
- Acronym / sponsor ID
- 19-0546
- Conditions
- Linear Growth, Neurodevelopment, Gut Microbiome
- Keywords
- Complementary Feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 24 Oct 2019 (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 overall objective of this project is to understand how consuming a prescribed diet of different infant foods (which may contain cereals,fruits, vegetables, meats, dairy) during the time of early complementary feeding (~5 to 12 months) in breastfed infants has on growth trajectories, neurodevelopment and sleep patterns in relation to gut microbiota, compared with a traditional diet that is usually provided in the home to infants.
The three primary aims include:
Aim 1: Identify the effects that the prescribed early complementary feeding specific study diet has on growth trajectories in breastfed infants.
Aim 2: Identify whether the relationship between the prescribed early complementary feeding specific study diet and growth is mediated by gut microbiota.
Aim 3: Characterize infant neurodevelopment and sleep patterns.
Detailed description
Some details are intentionally left to out to preserve the scientific integrity of the study, and they will be included in the record after the study is completed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Provided Diet | Experimental | Other: Baby FoodsA group of complementary foods provided to participants by researchers. |
| Traditional Diet | Placebo comparator | Other: Foods from the homeNo study foods provided to participants by researchers. Participants will eat a typical diet provided by caregivers. |
Who may qualify
- Ages
- 5 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Full term: gestational age > 37 weeks
- Exclusively breastfed (< 2 weeks of cumulative formula exposure). Any formula consumption on a given day is considered one day of formula exposure. During the intervention, if the participant receives more than 50% of the liquid diet from infant formula, s/he will be excluded from the study.
- Maternal conditions such as gestational diabetes mellitus, preeclampsia, multiple pregnancies are acceptable.
Key exclusion criteria (5 listed)
- Large for gestational age or small for gestational age
- Antibiotic use from birth to the time of enrollment
- Documented food allergies
- Previous complementary food exposure
- Conditions that would affect protein metabolism or growth
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 |
|---|---|---|
| Baby FoodsCommercially available baby foods | Other | Study Provided Diet |
| Foods from the homeCaregiver will provide participant with usual foods from the home | Other | Traditional Diet |
Primary outcome
Weight
Time frame: Over 6 months
Measured in kg
Length
Time frame: Over 6 months
Measured in cm
Gut Microbiome
Time frame: Over 6 months
Gut microbiota structure by 16S sequencing
11 secondary outcomes
Neurodevelopment
Time frame: At 12 months of age
Duration of sleep
Time frame: Over 6 months
Body composition
Time frame: Over 6 months
Serum c-reactive protein (CRP-hs)
Time frame: Over 6 months
Serum IGF-1 (Insulin-like growth factor1/ somatomedin C)
Time frame: Over 6 months
Serum IGFBP-3 (Insulin-like growth factor-binding protein 3)
Time frame: Over 6 months
Dietary intake
Time frame: Over 6 months
Total calories in breast milk
Time frame: Over 6 months
Total carbohydrates in breast milk
Time frame: Over 6 months
Total protein in breast milk
Time frame: Over 6 months
Total fat in breast milk
Time frame: Over 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Derived from this study: PubMed 37506974Odiase E, Frank DN, Young BE, Robertson CE, Kofonow JM, Davis KN, Berman LM, Krebs NF, Tang M. The Gut Microbiota Differ in Exclusively Breastfed and Formula-Fed United States Infants and are Associated with Growth Status. J Nutr. 2023 Sep;153(9):2612-2621. doi: 10.1016/j.tjnut.2023.07.009. Epub 2023 Jul 26.
- Individual participant dataSharing planned: No
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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.
Minghua Tang, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby Foods and Foods from the home in people with Linear Growth and Neurodevelopment, run by University of Colorado, Denver 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 3 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: status not confirmed, as of the sponsor's last update on 2 Feb 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. Some participants in this study may receive a placebo. 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 Minghua Tang, PhD (303-724-3248, minghua.tang@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Over 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04137445, which also lists 1 linked publication.
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 2 Feb 2023.