Gut MicrobiomeMINTNCT05012930
Effects of Complementary Feeding on Infant Growth and Gut Health
A study testing Baby Foods - Meat, Baby Foods - Dairy and Baby Foods - Plant in people with Gut Microbiome and Linear Growth, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about how consuming different foods during the time of early complementary feeding (~5 to 12 months) affects growth and the development of bacteria living inside your baby's gut through school-age. Read more about this study
- Who is it for?
- Ages 4 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome, Linear Growth
- What is being tested?
- Baby Foods - Meat, Baby Foods - Dairy and Baby Foods - Plant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 267 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 31 Aug 2026
- Phase
- Interventional
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 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full term;
- Generally healthy without conditions that would affect protein metabolism or growth
- No previous complementary food exposure
- Vaginal delivery
- No prior exposure of antibiotics during delivery or after birth
- Able to consume study foods
- Single birth.
Who cannot join
- Pre-term infants.
- Having conditions that would affect normal growth
- Had complementary foods prior to the start of the study
- Not willing to consume the complementary foods provided
- Antibiotics exposure during delivery or from birth to 5 months of life
- Multiple births
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
This study plans to learn more about how consuming different foods during the time of early complementary feeding (~5 to 12 months) affects growth and the development of bacteria living inside your baby's gut through school-age. The results from this study will potentially help to support future recommendations and dietary guidance for infant feeding practices.
The three primary aims include:
Aim 1. Identify the impact of dietary patterns with different protein-rich foods on infant growth.
Aim 2. Identify the impact of dietary patterns with different protein-rich foods on infant gut microbiota development.
Aim 3. Identify gut microbial taxa and genes that affect infant growth.
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
- Gut Microbiome, Linear Growth
- Being tested
- Baby Foods - Meat, Baby Foods - Dairy, Baby Foods - Plant, Foods from the home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby Foods - MeatOther
Commercially available baby foods
Baby Foods - DairyOther
Commercially available baby foods
Baby Foods - PlantOther
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 - Meat | Experimental | A group of complementary foods provided to participants by researchers. Receives: Other: Baby Foods - Meat |
| Study Provided Diet - Plant | Experimental | A group of complementary foods provided to participants by researchers. Receives: Other: Baby Foods - Dairy |
| Study Provided Diet - Dairy | Experimental | A group of complementary foods provided to participants by researchers. Receives: Other: Baby Foods - Plant |
| 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
Body composition
Body fat mass, fat-free mass measured by stable isotopes
Measured: Over 6 months
Gut Microbiome
Gut microbiota structure by 16S sequencing
Measured: Over 6 months
Secondary outcomes (10)
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
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
Serum c-reactive protein (CRP-hs)
Measured in mg/L
Measured: Over 6 months
Plasma alpha 1-acid glycoprotein (AGP)
Measured in mg/L
Measured: Over 6 months
Dietary intake
3 day dietary recall with results generated by NDSR software
Measured: Over 6 months
Food acceptance
Coded from behavioral observations and consumption measured in g
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 posted19 Aug 2021
- Study start1 Aug 2021
- Primary completion1 Aug 2025
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gut MicrobiomeStudies 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
- Model description
- 6 months intervention from \~5-12 months with follow-up assessments at 18 and 24 months.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012930
- Sponsor's protocol ID
- 20-2232
- Other IDs
- 1R01DK126710-01
- Acronym
- MINT
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2021
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taren D, Matzeller K, Gilley SP, Hernandez M, Kemp JF, Armstrong M, Doenges K, Krebs NF, Tang M. Infant hyperglycemic excursions by saliva 1,5-anhydroglucitol varied by weight status, rapid weight gain, and mode of feeding: an exploratory secondary analysis. Am J Clin Nutr. 2026 May;123(5):101254. doi: 10.1016/j.ajcnut.2026.101254. Epub 2026 Feb 26.
PubMed 41763581Tang M, Matz KL, Berman LM, Davis KN, Melanson EL, Frank DN, Hendricks AE, Krebs NF. Effects of Complementary Feeding With Different Protein-Rich Foods on Infant Growth and Gut Health: Study Protocol. Front Pediatr. 2022 Jan 13;9:793215. doi: 10.3389/fped.2021.793215. eCollection 2021.
PubMed 35096709