Complementary Feeding for Infant Growth and Gut Health

(MINT Trial)

Overseen By Minghua Tang, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Antibiotics

Disqualifiers: Pre-term, Growth conditions, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different protein-rich foods affect infant growth and gut health from around 5 to 12 months. Some babies will receive diets rich in meat, plant proteins, or dairy, while others will continue with their usual diet. Researchers aim to identify which foods promote better growth and healthier gut bacteria, potentially guiding future baby feeding recommendations. Families with full-term, healthy infants who have not yet started on complementary foods (additional foods given to infants alongside breast milk or formula) and are open to trying the provided diets might be a good fit. As an unphased trial, this study offers families the chance to contribute to important research that could shape future dietary guidelines for infants.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking current medications. It focuses on infants' diets and growth, so it's best to consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that introducing solid foods to a baby's diet along with milk, known as complementary feeding, is generally well-tolerated. Studies have found that diets including meat can help babies grow taller without major safety concerns. In some cases, these diets have also improved important nutrients like iron and zinc in babies, which are crucial for healthy development.

Evidence suggests that plant-based diets are safe and effective during complementary feeding. This type of diet can increase the variety of beneficial gut bacteria, aiding digestion. No significant negative effects have been reported from these diets.

Research on dairy-based diets also indicates no major safety issues. Adding dairy to a baby's diet is common and usually safe, supporting growth alongside milk.

These findings offer reassurance about the safety of these different diets during complementary feeding. Always consult a healthcare provider for personalized advice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different types of complementary feeding can impact infant growth and gut health. Unlike typical infant diets, which often rely on a mix of family-provided foods, this trial provides specific diets rich in either meat, plants, or dairy to see how each affects development. By understanding the distinct effects of these diets, researchers hope to uncover new insights into optimizing nutrition during the crucial early stages of life. This could lead to more tailored and effective dietary recommendations for infants worldwide.

What evidence suggests that this trial's treatments could be effective for infant growth and gut health?

This trial will compare different complementary feeding approaches for infants. Research has shown that adding meat to a baby's diet, one of the study-provided diets, can increase the variety of healthy bacteria in their intestines. Studies have found that a diet with meat can also help babies grow better and improve their iron and zinc levels. Another arm of this trial will provide a plant-based diet, though evidence about its effects on gut health is less clear. High protein intake with fewer plant foods might have negative effects in the long run. The trial will also include a dairy-based diet, which can alter gut function, but the exact benefits remain unclear. Overall, each diet in this trial has potential benefits, but meat-based diets have shown more clear positive effects on growth and gut health in infants. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for full-term, healthy infants with no prior complementary food exposure or antibiotics use from birth to 5 months. Eligible babies must be able to eat the study foods and come from a single birth delivered vaginally.

Inclusion Criteria

No previous complementary food exposure

I am generally healthy with no conditions affecting my protein metabolism or growth.

No prior exposure of antibiotics during delivery or after birth

Exclusion Criteria

I am not willing to eat the study-provided food.

I was exposed to antibiotics from birth to 5 months old.

Had complementary foods prior to the start of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive complementary foods with different protein-rich foods to study their effects on growth and gut microbiota development

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Complementary Feeding

Trial Overview The study tests how different protein-rich baby foods (meat, plant, dairy) versus home-prepared foods affect an infant's growth and gut bacteria development during early feeding (~5-12 months).

How Is the Trial Designed?

Group I: Study Provided Diet - Plant Experimental Treatment 1 Intervention

A group of complementary foods provided to participants by researchers.

Group II: Study Provided Diet - Meat Experimental Treatment 1 Intervention

A group of complementary foods provided to participants by researchers.

Group III: Study Provided Diet - Dairy Experimental Treatment 1 Intervention

A group of complementary foods provided to participants by researchers.

Group IV: Traditional Diet Placebo Group 1 Intervention

No study foods provided to participants by researchers. Participants will eat a typical diet provided by caregivers.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9116017/

complementary feeding for a healthy infant gut microbiome—a ... The introduction of complementary foods and changes in milk feeding result in modifications to gastrointestinal function.

2. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2021.793215/full

Effects of Complementary Feeding With Different Protein ... We directly compare the effects of dietary patterns with common protein-rich foods (meat, dairy, plant) on infant growth trajectories and gut microbiota ...

3. mdpi.com mdpi.com/2072-6643/17/5/743

Complementary Feeding and Infant Gut Microbiota A lack of conclusive evidence exists describing the relationship between complementary feeding and gut microbiota outcomes in infants.

4. tandfonline.com tandfonline.com/doi/full/10.1080/10408398.2024.2439036

The effect of complementary foods on the colonic ... This systematic review collected evidence of the effect of individual foods on the fecal microbiota of weaning infants (4–12 months old) using five databases.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622106073

Complementary Feeding Interventions Have a Small but ... According to our analysis, complementary feeding interventions have small but significant impacts on linear and ponderal growth among children aged 6–23 mo in ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33684940/

Complementary feeding of infants and young children 6 to ... Complementary feeding, when foods are introduced to complement a milk-based diet, generally occurs between 6 and 23 months of age.

7. who.int who.int/publications/i/item/9789240081864

WHO Guideline for complementary feeding of infants and ... This guideline provides global, normative evidence-based recommendations on complementary feeding of infants and young children 6–23 months of age

8. pubs.rsc.org pubs.rsc.org/en/content/articlehtml/2024/fo/d4fo03948c

Impact of complementary feeding on infant gut microbiome ... This study enrolled 200 families to assess the impact of complementary feeding on infant growth and health outcomes. Data included detailed ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0021755721000991

Evaluation of the complementary feeding practices, dietary ... To evaluate the complementary feeding practices, food intake, and nutritional status of infants on a cow's milk protein elimination diet.

10. nature.com nature.com/articles/s41430-025-01671-5

Association between feeding practices and infants ... Appropriate feeding habits are linked to improved growth, brain development, and reduced child mortality [15]. WHO and UNICEF recommend ...