Effect of Nutritional Intervention on Metabolic Response in Infants

October 4, 2021 updated by: Nestlé

Effect of Nutritional Intervention on Metabolic Response in Infants: A Single-Blind, Randomized, Controlled Trial

The purpose of this study is to determine the glucose response of complementary feeding regimens consisting of two different follow-up formulas (FUFs) and infant cereals (ICs).

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

This is a prospective, randomized, single-blind, controlled, 2-arm parallel group trial in infants aged 6 months (26 weeks) at enrollment, who are no longer breastfed, and who are ready but have not yet started complementary feeding. They will be fed one of two different isocaloric feeding regimens (Experimental [EXPL] or Control [CTRL]) consisting of different follow-up formulas (FUFs) and infant cereals (ICs). The main purpose of this study is to determine the glucose response of these two different complementary feeding regimens. All enrolled infants will participate in the trial for approximately 6 months.

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.
102

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

  • Philippines
      • Las Piñas, Philippines, 1742
        • Las Piñas Doctors Hospital

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

5 months to 5 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:.

  1. Written informed consent has been obtained from both parent / liable parent or legally acceptable representative (LAR), if applicable
  2. Healthy infant who was singleton, full-term gestational birth (≥ 37 completed weeks of gestation) with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg
  3. Infant is no longer breastfeeding or receiving breast milk, has not yet started FUF, and is developmentally ready to begin complementary feeding
  4. Infant's parent(s)/guardian is of legal age of consent, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol.
  5. At screening visit (visit 0), infant is 24 - 26 weeks (5½ - 6 months) old
  6. Weight-for-height value >-2 standard deviations from the WHO Child Growth Standards median

Exclusion Criteria:

  1. Chronic infectious, metabolic, or other disease including any condition that in the opinion of the investigator may impact feeding, growth or adherence to study procedures
  2. Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)
  3. Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, gluten sensitivity or severe food allergies that impact diet
  4. Born to mothers with gestational diabetes or type 1 diabetes
  5. Major medical/surgical event requiring prolonged hospitalization during the first 6 months
  6. Receiving or having received insulin, growth hormone or any other medication known to affect glucose or carbohydrate metabolism or pre- or probiotics known to affect fecal microbiota prior to enrollment
  7. Subjects or subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol
  8. Currently participating or having participated in another clinical trial within 4 weeks prior to trial start

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
  • Masking: SINGLE

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: EXPL feeding regimen
Lower protein / lower estimated glycemic index regimen
Other: EXPL feeding regimen
EXPL FUF (lower protein and 100% lactose) + EXPL IC (whole grains and legumes)
ACTIVE_COMPARATOR: CTRL feeding regimen
Standard protein / standard glycemic index regimen
Other: CTRL feeding regimen
CTRL FUF (standard protein content and carbohydrate profile) + CTRL IC (refined grains)

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
Glucose peak
Time Frame: Study days 85-92
Average of the glucose peaks measured by a continuous glucose monitor
Study days 85-92

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
Glycemic response
Time Frame: Study days 85-92
Incremental area under the blood glucose response curve
Study days 85-92
Glucose response variability
Time Frame: Study days 85-92
Mean amplitude of glycemic excursions, standard deviation, J-index
Study days 85-92
Skinfold thickness
Time Frame: age 6 months, 9 months, and 12 months
Subscapular and triceps skinfold thicknesses
age 6 months, 9 months, and 12 months
Weight
Time Frame: age 6 months, 9 months, and 12 months
Weight (g)
age 6 months, 9 months, and 12 months
Length
Time Frame: age 6 months, 9 months, and 12 months
Length (cm)
age 6 months, 9 months, and 12 months
Head circumference
Time Frame: age 6 months, 9 months, and 12 months
Head circumference (cm)
age 6 months, 9 months, and 12 months
Body mass index (BMI)
Time Frame: age 6 months, 9 months, and 12 months
Weight and height will be combined to report BMI in kg/m^2
age 6 months, 9 months, and 12 months
Weight-for-age z-score
Time Frame: age 6 months, 9 months, and 12 months
Weight-for-age z-score based on World Health Organization (WHO) growth charts
age 6 months, 9 months, and 12 months
Weight-for-length z-score
Time Frame: age 6 months, 9 months, and 12 months
Weight-for-length z-score based on WHO growth charts
age 6 months, 9 months, and 12 months
Length-for-age z-score
Time Frame: age 6 months, 9 months, and 12 months
Length-for-age z-score based on WHO growth charts
age 6 months, 9 months, and 12 months
Head circumference-for-age z-score
Time Frame: age 6 months, 9 months, and 12 months
Head circumference-for-age z-score based on WHO growth charts
age 6 months, 9 months, and 12 months
BMI-for-age z-score
Time Frame: age 6 months, 9 months, and 12 months
BMI-for-age z-score based on WHO growth charts
age 6 months, 9 months, and 12 months
Insulin secretion
Time Frame: age 6 months, 9 months, and 12 months
Urinary C-peptide:creatinine ratio
age 6 months, 9 months, and 12 months
Dietary intake
Time Frame: age 6 months, 9 months, and 12 months
Total energy, carbohydrate and protein intake calculated from food recalls / diaries
age 6 months, 9 months, and 12 months
Stool microbiota composition
Time Frame: age 6 months, 7.5 months, 9 months, and 12 months
Fecal microbiota composition assessed using next generation sequencing
age 6 months, 7.5 months, 9 months, and 12 months
Stool pH
Time Frame: age 6 months, 7.5 months, 9 months, and 12 months
Stool pH
age 6 months, 7.5 months, 9 months, and 12 months
Stool microbiota metabolism
Time Frame: age 6 months, 7.5 months, 9 months, and 12 months
Stool organic acids
age 6 months, 7.5 months, 9 months, and 12 months
Gastrointestinal (GI) tolerance
Time Frame: age 6 months, 9 months, and 12 months
GI tolerance assessed using the Infant Gastrointestinal Symptom Questionnaire (IGSQ). IGSQ scores range from 13 to 65, with lower scores indicating lower GI symptom burden.
age 6 months, 9 months, and 12 months
Health-related quality of life
Time Frame: age 6 months, 9 months, and 12 months
Health-related quality of life using the Infant and Toddler Quality of Life Questionnaire Short Form (ITQOL-SF47). ITQOL-SF47 scores range from 0 to 100, with higher scores indicating a more favorable health-related quality of life.
age 6 months, 9 months, and 12 months

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
Insulin-like growth factor-1 (IGF-1)
Time Frame: age 6 months, 9 months, and 12 months
Urinary IGF-1
age 6 months, 9 months, and 12 months
Urinary metabolomic profile
Time Frame: age 6 months, 9 months, and 12 months
Untargeted analysis of urine metabolites by H1-nuclear magnetic resonance (NMR) spectroscopy.
age 6 months, 9 months, and 12 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.
Nestlé

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.
July 31, 2020

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.
April 29, 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.
June 9, 2021

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).
July 6, 2020

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.
July 22, 2020

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.
July 23, 2020

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.
October 5, 2021

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.
October 4, 2021

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.
October 1, 2021

More Information

Terms related to this study

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.
  • 18.17.INF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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