Infant GrowthNCT02142647
Effect of Protein From Complementary Foods on Infant Growth, Body Composition and Gut Health
A study testing a high-protein complementary diet with meat and a high-protein complementary diet with dairy in people with Infant Growth and Infant Body Fat, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 5 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Growth, Infant Body Fat, Infant Gut Microbiome
- What is being tested?
- a high-protein complementary diet with meat and a high-protein complementary diet with dairy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Aug 2018
- 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 1 month to 5 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1-5 months of age
- Formula fed
- On breast milk less than 1 month
- Healthy
- Term Birth (36-42 weeks)
- Appropriate for gestational age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dietary Protein From Meat vs. Dairy on Infant Growth, Body Composition and Gut Health
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.
Read the detailed description
Two observational follow-up visits will be conducted at 18 and 24 months of age.
- Conditions
- Infant Growth, Infant Body Fat, Infant Gut Microbiome
- Being tested
- a high-protein complementary diet with meat, a high-protein complementary diet with dairy
- Keywords
- infant growth, dietary protein, body composition, gut microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a high-protein complementary diet with meatBehavioural
infants will consume a high-protein complementary diet with protein mainly from meat
a high-protein complementary diet with dairyBehavioural
infants will consume a high-protein complementary diet with protein mainly from dairy
| Study group | Role | What they receive |
|---|---|---|
| meat group | Active comparator | Infants in this group will receive complementary foods with high protein content mainly from meat Receives: Behavioral: a high-protein complementary diet with meat |
| dairy group | Active comparator | infants in this group will receive complementary foods mainly from dairy Receives: Behavioral: a high-protein complementary diet with dairy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Change in Body composition
body composition: fat mass, fat-free mass will be assessed at the beginning and end of the study
Measured: 5 and 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infant 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
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado Clinical & Translational Sciences Institute, National Cattlemen's Beef Association, a contractor to the Beef Checkoff, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Nancy Krebs, MD, Principal investigator, UC Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142647
- Sponsor's protocol ID
- 14-0139
- Status last verified
- Jul 2019
- First submitted
- 14 May 2014
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- 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 37506974Tang 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.
PubMed 30413312Tang 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.
PubMed 29722841
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Protein From Meat vs. Dairy on Infant Growth, Body Composition and Gut Health
- ClinicalTrials.gov ID
- NCT02142647
- Acronym / sponsor ID
- 14-0139
- Conditions
- Infant Growth, Infant Body Fat, Infant Gut Microbiome
- Keywords
- infant growth, dietary protein, body composition, gut microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Colorado Clinical & Translational Sciences Institute, National Cattlemen's Beef Association, a contractor to the Beef Checkoff, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 2014
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 20 May 2014 (estimated)
- 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.
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.
Detailed description
Two observational follow-up visits will be conducted at 18 and 24 months of age.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| meat group | Active comparator | Behavioral: a high-protein complementary diet with meatInfants in this group will receive complementary foods with high protein content mainly from meat |
| dairy group | Active comparator | Behavioral: a high-protein complementary diet with dairyinfants in this group will receive complementary foods mainly from dairy |
Who may qualify
- Ages
- 1 month to 5 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 1-5 months of age
- Formula fed
- On breast milk less than 1 month
- Healthy
- Term Birth (36-42 weeks)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| a high-protein complementary diet with meatinfants will consume a high-protein complementary diet with protein mainly from meat | Behavioural | meat group |
| a high-protein complementary diet with dairyinfants will consume a high-protein complementary diet with protein mainly from dairy | Behavioural | dairy group |
Primary outcome
Change of linear growth
Time frame: 6 months
growth, including linear growth (length), body weight, and all the Z scores will be recorded at the beginning and end of the study.
1 secondary outcome
Change in Body composition
Time frame: 5 and 12 months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- 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.
- Derived from this study: PubMed 30413312Tang 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.
- Derived from this study: PubMed 29722841Tang 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.
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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.
Nancy Krebs, MD principal investigator
UC 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 a high-protein complementary diet with meat and a high-protein complementary diet with dairy in people with Infant Growth and Infant Body Fat, 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 10 Jul 2019. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of linear growth (time frame: 6 months). 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 NCT02142647, which also lists 3 linked publications.
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 10 Jul 2019.