Infant FormulaBabyGrowthNCT03456934
Lower Protein Intake and Long-term Risk of Obesity and Cardiovascular Disease
A study testing Modified infant formula and Standard infant formula in people with Infant Formula and Growth, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
Trial summary
The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Read more about this study
- Who is it for?
- Ages 13 to 15 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant Formula, Growth
- What is being tested?
- Modified infant formula and Standard infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Aug 2017to 13 Oct 2022
- 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 13 to 15 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy term infant
- Infant is aged 14 weeks (+/- 1 week)
- Infant is exclusively formula feeding or predominantly breast-feeding at age 14 weeks
Who cannot join
- Any adverse maternal, fetal or infant medical history that may have effects on growth and/or development
- Infant born with congenital disease or malformation affecting growth and/or development
- Food allergy to any trial products (e.g. milk, soy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lower Protein Intake and Long-term Risk of Obesity and Cardiovascular Disease: A Multi-centred, Randomised, Controlled Trial
The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and cardiovascular disease.
Read the detailed description
Obesity and its cardiovascular consequences are the most important causes of morbidity and mortality worldwide. Breastfed infants have been shown to have less cardiovascular risk factors in adulthood, which can be partially explained by their slower growth compared to formula fed infants. The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and atherosclerotic cardiovascular disease (CVD), the critical windows for these programming effects, and the mechanisms of action.
- Conditions
- Infant Formula, Growth
- Being tested
- Modified infant formula, Standard infant formula
- Keywords
- Protein requirements, Adiposity, Body composition, Cardiovascular health
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified infant formulaOther
Test formula with lower protein content than standard formula
Standard infant formulaOther
Standard infant formula
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Modified infant formula given from 3 to 12 months of age, as per standard requirement. Receives: Other: Modified infant formula |
| Control Group | Active comparator | Standard infant formula given from 3 to 12 months of age, as per standard requirement. Receives: Other: Standard infant formula |
| Breast-fed Reference Group | No intervention | Non-randomized infants who are predominantly breast-fed at time of enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant weight gain
Rate of weight gain (g/d)
Measured: Between ages 14 weeks (+/- 1 week) and 12 months (+/- 2 weeks)
Secondary outcomes (4)
Body mass index (BMI)-for-age Z-score
Based on World Health Organization (WHO) growth standards
Measured: Age 2 years (+/- 1 month)
Height-for-age Z-score
Based on WHO growth standards
Measured: Age 2 years (+/- 1 month)
Adiposity
Sum of 4 skinfolds (triceps, biceps, sub-scapular, supra-iliac)
Measured: Age 2 years (+/- 1 month)
Fat mass
Deuterium dilution (assessed in subset)
Measured: Age 2 years (+/- 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start7 Aug 2017
- Primary completion30 Sep 2021
- Study completion13 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant FormulaStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, double-blind with nonrandomized breast-fed reference group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University College, London
- Responsible party
- Sponsor
- Investigators
- Atul Singhal, MD, Principal investigator, Childhood Nutrition Research Centre, University College London, Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456934
- Sponsor's protocol ID
- 15.09.INF
- Acronym
- BabyGrowth
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2018
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.
PubMed 37929831
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Protein Intake and Long-term Risk of Obesity and Cardiovascular Disease: A Multi-centred, Randomised, Controlled Trial
- ClinicalTrials.gov ID
- NCT03456934
- Acronym / sponsor ID
- BabyGrowth / 15.09.INF
- Conditions
- Infant Formula, Growth
- Keywords
- Protein requirements, Adiposity, Body composition, Cardiovascular health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- University College, London
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 13 Oct 2022 (actual)
- First posted
- 7 Mar 2018 (actual)
- 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.
The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and cardiovascular disease.
Detailed description
Obesity and its cardiovascular consequences are the most important causes of morbidity and mortality worldwide. Breastfed infants have been shown to have less cardiovascular risk factors in adulthood, which can be partially explained by their slower growth compared to formula fed infants. The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and atherosclerotic cardiovascular disease (CVD), the critical windows for these programming effects, and the mechanisms of action.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, randomized, double-blind with nonrandomized breast-fed reference group
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Modified infant formulaModified infant formula given from 3 to 12 months of age, as per standard requirement. |
| Control Group | Active comparator | Other: Standard infant formulaStandard infant formula given from 3 to 12 months of age, as per standard requirement. |
| Breast-fed Reference Group | No intervention | –Non-randomized infants who are predominantly breast-fed at time of enrollment. |
Who may qualify
- Ages
- 13 to 15 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy term infant
- Infant is aged 14 weeks (+/- 1 week)
- Infant is exclusively formula feeding or predominantly breast-feeding at age 14 weeks
Key exclusion criteria (3 listed)
- Any adverse maternal, fetal or infant medical history that may have effects on growth and/or development
- Infant born with congenital disease or malformation affecting growth and/or development
- Food allergy to any trial products (e.g. milk, soy)
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 |
|---|---|---|
| Modified infant formulaTest formula with lower protein content than standard formula | Other | Experimental Group |
| Standard infant formulaStandard infant formula | Other | Control Group |
Primary outcome
Infant weight gain
Time frame: Between ages 14 weeks (+/- 1 week) and 12 months (+/- 2 weeks)
Rate of weight gain (g/d)
4 secondary outcomes
Body mass index (BMI)-for-age Z-score
Time frame: Age 2 years (+/- 1 month)
Height-for-age Z-score
Time frame: Age 2 years (+/- 1 month)
Adiposity
Time frame: Age 2 years (+/- 1 month)
Fat mass
Time frame: Age 2 years (+/- 1 month)
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 17 Mar 2023.
- Derived from this study: PubMed 37929831Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.
- Individual participant dataSharing planned: No
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Infant ALL
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.
Atul Singhal, MD principal investigator
Childhood Nutrition Research Centre, University College London, Institute of Child Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified infant formula and Standard infant formula in people with Infant Formula and Growth, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
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 3 inclusion and 3 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 17 Mar 2023. 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 Kingdom. 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?
Infant weight gain (time frame: Between ages 14 weeks (+/- 1 week) and 12 months (+/- 2 weeks)). 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 NCT03456934, which also lists 1 linked publication.
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 17 Mar 2023.