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Complementary Feeding for Infant Growth and Gut Health (MINT Trial)

N/A
Recruiting
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 6 months
Awards & highlights

MINT Trial Summary

This trial plans to study how different diets during early complementary feeding affects growth and gut bacteria development, which could help create future dietary recommendations.

Who is the study for?
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.Check my eligibility
What is being tested?
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).See study design
What are the potential side effects?
Since this trial involves dietary interventions with common baby foods, there are no specific side effects listed; however, individual reactions such as allergies could occur.

MINT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and over 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body composition
Gut Microbiome
Head Circumference
+2 more
Secondary outcome measures
Dietary intake
Plasma alpha 1-acid glycoprotein (AGP)
Serum IGF-1 (Insulin-like growth factor1/ somatomedin C)
+6 more

MINT Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Study Provided Diet - PlantExperimental Treatment1 Intervention
A group of complementary foods provided to participants by researchers.
Group II: Study Provided Diet - MeatExperimental Treatment1 Intervention
A group of complementary foods provided to participants by researchers.
Group III: Study Provided Diet - DairyExperimental Treatment1 Intervention
A group of complementary foods provided to participants by researchers.
Group IV: Traditional DietPlacebo Group1 Intervention
No study foods provided to participants by researchers. Participants will eat a typical diet provided by caregivers.

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,314,941 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,734 Previous Clinical Trials
2,148,583 Total Patients Enrolled

Media Library

Complementary Feeding Clinical Trial Eligibility Overview. Trial Name: NCT05012930 — N/A
Gut Microbiome Research Study Groups: Study Provided Diet - Meat, Study Provided Diet - Plant, Traditional Diet, Study Provided Diet - Dairy
Gut Microbiome Clinical Trial 2023: Complementary Feeding Highlights & Side Effects. Trial Name: NCT05012930 — N/A
Complementary Feeding 2023 Treatment Timeline for Medical Study. Trial Name: NCT05012930 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the overall participation rate of this research project?

"Correct. According to info available on clinicaltrials.gov, this medical experiment was initially posted in August 2021 and is now actively recruiting participants. The trial aims to collect data from 300 patients at a single site."

Answered by AI

Can elders over the age of 60 enroll in this research?

"This research study accepts enrolment from participants aged between 4 months and 50 months. Additionally, there are 3 trials for minors and 7 for elderly individuals."

Answered by AI

Are there currently any opportunities to join this clinical trial?

"Affirmative. According to the information on clinicaltrials.gov, this research project is actively recruiting participants since its original posting date of August 1st 2021 and was last updated on August 12th 2021. The study requires 300 volunteers from a single medical site."

Answered by AI

What are the desired outcomes of this experiment?

"The primary assessment for this trial over a 6 month period is body composition. Secondary objectives include measuring total protein in breast milk (g/100 mL), serum c-reactive protein (CRP-hs) (mg/L), and dietary intake through 3 day diet recall evaluated with NDSR software."

Answered by AI

Who is the ideal participant for this clinical experiment?

"To qualify for this medical trial, individuals must be between 4 and 50 months old with a healthy gut microbiome. The researchers are searching for 300 volunteers in total."

Answered by AI
Recent research and studies
Frontiers in PediatricsJournal
Effects of Complementary Feeding with Different Protein-rich Foods on Infant Growth and Gut Health: Study Protocol
Tang, Minghua, Kinzie L. Matz, Lillian M. Berman, Kathryn N. Davis, Edward L. Melanson, Daniel N. Frank, Audrey E. Hendricks, and Nancy F. Krebs. 2022. “Effects of Complementary Feeding with Different Protein-rich Foods on Infant Growth and Gut Health: Study Protocol”. Frontiers in Pediatrics. Frontiers Media SA. doi:10.3389/fped.2021.793215.
clinicaltrials.govStudy
Effects of Complementary Feeding on Infant Growth and Gut Health
2021. "Effects of Complementary Feeding on Infant Growth and Gut Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05012930.
~25 spots leftby Aug 2024
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