Lower Protein Intake and Long-term Risk of Obesity and Cardiovascular Disease (BabyGrowth)

March 16, 2023 updated by: Société des Produits Nestlé (SPN)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
249

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1N 1EH
        • UCL Institute of Child Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 months to 3 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy term infant
  • Infant is aged 14 weeks (+/- 1 week)
  • Infant is exclusively formula feeding or predominantly breast-feeding at age 14 weeks

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
Modified infant formula given from 3 to 12 months of age, as per standard requirement.
Other: Modified infant formula
Test formula with lower protein content than standard formula
Active Comparator: Control Group
Standard infant formula given from 3 to 12 months of age, as per standard requirement.
Other: Standard infant formula
Standard infant formula
No Intervention: Breast-fed Reference Group
Non-randomized infants who are predominantly breast-fed at time of enrollment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Infant weight gain
Time Frame: Between ages 14 weeks (+/- 1 week) and 12 months (+/- 2 weeks)
Rate of weight gain (g/d)
Between ages 14 weeks (+/- 1 week) and 12 months (+/- 2 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body mass index (BMI)-for-age Z-score
Time Frame: Age 2 years (+/- 1 month)
Based on World Health Organization (WHO) growth standards
Age 2 years (+/- 1 month)
Height-for-age Z-score
Time Frame: Age 2 years (+/- 1 month)
Based on WHO growth standards
Age 2 years (+/- 1 month)
Adiposity
Time Frame: Age 2 years (+/- 1 month)
Sum of 4 skinfolds (triceps, biceps, sub-scapular, supra-iliac)
Age 2 years (+/- 1 month)
Fat mass
Time Frame: Age 2 years (+/- 1 month)
Deuterium dilution (assessed in subset)
Age 2 years (+/- 1 month)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Infant weight gain
Time Frame: Between 6 and 12 months
Rate of weight gain (g/d)
Between 6 and 12 months
Weight
Time Frame: Ages 4, 5, 6, 12 and 24 months
Body weight (kg)
Ages 4, 5, 6, 12 and 24 months
Length or height
Time Frame: Ages 4, 5, 6, 12 and 24 months
Length or height (cm)
Ages 4, 5, 6, 12 and 24 months
Head circumference
Time Frame: Ages 4, 5, 6, 12 and 24 months
Head circumference (cm)
Ages 4, 5, 6, 12 and 24 months
Body mass index
Time Frame: Ages 6, 12 and 24 months
Weight and length or height will be combined to report BMI in kg/m^2
Ages 6, 12 and 24 months
Weight-for-age Z-score
Time Frame: Ages 14 weeks and 4, 5, 6, 12 and 24 months
Based on WHO growth standards
Ages 14 weeks and 4, 5, 6, 12 and 24 months
Weight-for-length Z-score
Time Frame: Ages 14 weeks and 4, 5, 6, 12 and 24 months
Based on WHO growth standards
Ages 14 weeks and 4, 5, 6, 12 and 24 months
Height-for-age Z-score
Time Frame: Ages 14 weeks and 4, 5, 6, and 12 months
Based on WHO growth standards
Ages 14 weeks and 4, 5, 6, and 12 months
BMI-for-age Z-score
Time Frame: Ages 14 weeks and 4, 5, 6, and 12 months
Based on WHO growth standards
Ages 14 weeks and 4, 5, 6, and 12 months
Adverse events
Time Frame: Ages 14 weeks and 4, 5, 6, 9, 12 and 24 months
Safety
Ages 14 weeks and 4, 5, 6, 9, 12 and 24 months
Feeding intake
Time Frame: Ages 14 weeks and 4, 5, 6, and 12 months
Infant feeding questionnaire
Ages 14 weeks and 4, 5, 6, and 12 months
Feeding tolerance
Time Frame: Ages 14 weeks and 4, 5, 6, and 12 months
GI symptom and stool pattern questionnaire
Ages 14 weeks and 4, 5, 6, and 12 months
Metabolic markers of cardiovascular health
Time Frame: Ages 6 and 12 months
Blood sample (in a subset)
Ages 6 and 12 months
Blood pressure
Time Frame: At age 12 and 24 months
Systolic and diastolic blood pressure (in a subset)
At age 12 and 24 months
Appetite and feeding / eating behavior
Time Frame: Ages 14 weeks and 4, 5, 6, and 24 months
Baby and Children's Eating Behavior Questionnaire
Ages 14 weeks and 4, 5, 6, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Société des Produits Nestlé (SPN)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University College, London

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Atul Singhal, MD, Childhood Nutrition Research Centre, University College London, Institute of Child Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 13, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15.09.INF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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