NCT02142647

Brief Summary

Current research shows that dairy protein accelerates infant weight gain, which is a risk factor for later on obesity and metabolic syndrome. However, dietary protein from other sources haven't been studied yet. This longitudinal study will compare two complementary feeding regimens with dietary protein mainly from 1) meat; 2) dairy on infant growth, body composition and gut microbiome from 5 to 12 months of age in formula fed infants. Healthy infants at approximately 5 months of age will be randomized to either a meat protein, or a dairy protein group with complementary protein mainly from meat or dairy. Infants will consume one of these diets for 7 months (6-12 months of age) and infant growth, body composition, growth biomarkers and gut microbiome will be measured to compare between groups and over time.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

4.4 years

First QC Date

May 14, 2014

Last Update Submit

July 8, 2019

Conditions

Infant GrowthInfant Body FatInfant Gut Microbiome

Keywords

infant growthdietary proteinbody compositiongut microbiome

Outcome Measures

Primary Outcomes (1)

  • Change of linear growth

    growth, including linear growth (length), body weight, and all the Z scores will be recorded at the beginning and end of the study.

    6 months

Secondary Outcomes (1)

  • Change in Body composition

    5 and 12 months of age

Other Outcomes (1)

  • Change in gut microbiome

    5, 9.5 and 12 months of age

Study Arms (2)

meat group

ACTIVE COMPARATOR

Infants in this group will receive complementary foods with high protein content mainly from meat

Behavioral: a high-protein complementary diet with meat

dairy group

ACTIVE COMPARATOR

infants in this group will receive complementary foods mainly from dairy

Behavioral: a high-protein complementary diet with dairy

Interventions

a high-protein complementary diet with meatBEHAVIORAL

infants will consume a high-protein complementary diet with protein mainly from meat

meat group
a high-protein complementary diet with dairyBEHAVIORAL

infants will consume a high-protein complementary diet with protein mainly from dairy

dairy group

Eligibility Criteria

Age1 Month - 5 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • months of age
  • Formula fed
  • On breast milk less than 1 month
  • Healthy
  • Term Birth (36-42 weeks)
  • Appropriate for gestational age

You may not qualify if:

  • Congenital anomalies that impact feeding, growth, or development
  • Low birth weight
  • Not able to consume milk-based formula
  • Known chronic diseases or allergies affecting protein consumption/digestion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (3)

  • 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.

    PMID: 37506974DERIVED

  • Tang M, Andersen V, Hendricks AE, Krebs NF. Different Growth Patterns Persist at 24 Months of Age in Formula-Fed Infants Randomized to Consume a Meat- or Dairy-Based Complementary Diet from 5 to 12 Months of Age. J Pediatr. 2019 Mar;206:78-82. doi: 10.1016/j.jpeds.2018.10.020. Epub 2018 Nov 6.

    PMID: 30413312DERIVED

  • Tang M, Hendricks AE, Krebs NF. A meat- or dairy-based complementary diet leads to distinct growth patterns in formula-fed infants: a randomized controlled trial. Am J Clin Nutr. 2018 May 1;107(5):734-742. doi: 10.1093/ajcn/nqy038.

    PMID: 29722841DERIVED

MeSH Terms

Interventions

Meat

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Nancy Krebs, MD

    UC Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2014

First Posted

May 20, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

July 10, 2019

Record last verified: 2019-07

Locations

US(1)