Bottle FeedingNCT02010749
Protein Concentration in Infant Formula: A Follow-up Study of Growth at 2 Years of Age
An observational study of Bottle Feeding, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.
Trial summary
The primary objective of the study was to compare the growth parameters of children approximately 2* years of age, who as infants were randomized to receive either a lower-protein formula ("experimental formula"; EF) with 12.8 g/L protein or a standard formula (SF) with 14.1 g/L protein or who were human milk (HM) fed… Read more about this study
- Who is it for?
- Ages 2 to 3 years
- Conditions the study is for
- Bottle Feeding
- How many people
- 267 participants
- Where
- 1 sitePhilippines
- Study dates
- Oct 2010to Dec 2010
- Phase
- Observational
- 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 2 to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Children 2 years of age who were enrolled in the Wyeth Nutrition study
Who may be able to join
- Children who were enrolled in the Wyeth Nutrition study are eligible to participate in this study
Who cannot join
- Children who were not enrolled in the Wyeth Nutrition study are not eligible to participate in this study
- Children who have received any antibiotics and antifungal medications except topical within two weeks prior to enrollment are not eligible to participate in the stool microbiota study
- Children who are taking any medications known or suspected to affect fat digestion, absorption, and or metabolism, any vitamin and or mineral supplements which contain calcium, suppositories, bismuth-containing medications, herbal supplements, or medications that may neutralize or suppress gastric acid secretion, are not eligible to participate in the stool composition study
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Asian Hospital and Medical Center
Filinvest Corporate City, Alabang,, Muntinlupa City, 1780
About this study
The primary objective of the study was to compare the growth parameters of children approximately 2* years of age, who as infants were randomized to receive either a lower-protein formula ("experimental formula"; EF) with 12.8 g/L protein or a standard formula (SF) with 14.1 g/L protein or who were human milk (HM) fed for the first 4 months of life. The secondary objective was to describe diet and nutrient intake in this cohort of children. The exploratory objectives were to describe stool microbiota in a subset of this cohort and stool composition (stool soap and nonsoap fatty acids, total fatty acids, and minerals) in a second subset of this cohort.
(* The mean age of subjects was 33.0 months due to a delay in the study start-up.)
Read the detailed description
This was an observational, single-site, follow-up study of healthy children who as infants who had completed study 9052A1-3000. An attempt was made to contact all subjects who had completed study 9052A1-3000 by telephone to ask them to participate in study 9052A1-3001. Approximately 66 and 60 subjects were planned to participate in the stool microbiota and stool composition substudies, respectively.
- Conditions
- Bottle Feeding
- Medical subject headings
- Bottle Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Control: Children who had received Standard formula (SF) as infants | |
| Experimental | Experimental: Children who had received lower protein formula as infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight-for-Length Z-Scores
Primary Efficacy Endpoint: weight-for-length Z-score based on World Health Organization (WHO) growth charts.
Measured: 2 years of age
Secondary outcomes (6)
Weight-for-age Z-score
Weight-for-age Z-score based on World Health Organization (WHO) growth charts
Measured: 2 years of age
Length-for-age Z-score
Length-for-age Z-score based on World Health Organization (WHO) growth charts
Measured: 2 years of age
Head circumference-for-age Z-score
Head circumference-for-age Z-score based on World Health Organization (WHO) growth charts
Measured: 2 years of age
BMI-for-age Z-score
BMI-for-age Z-score based on WHO and Centers for Disease Control (CDC) growth charts
Measured: 2 years of age
Dietary intake
Dietary intake (servings per day), percent contribution to energy intake, and percent contribution to protein intake of Dietary endpoints included mean intake (servings per day), percentage contribution to energy intake, and percentage contribution to protein intake of:
- Cereal/cereal products
- Starchy roots/tubers
- Sugars/syrups
- Fats/oils
- Fish/meat/poultry
- Eggs
- Milk and milk products
- Dried beans/nuts/seeds
- Vegetables
- Fruits
- Miscellaneous foods
Measured: 2 years of age
Nutrient intake
Nutrition endpoints included mean intake and percentage adequacy based on the recommended intake of:
- Total energy (kcal)
- Protein (g)
- Carbohydrates (g) (mean intake only)
- Fat (g) (mean intake only)
- Iron (mg)
- Retinol equivalents (μg)
- Calcium (g)
- Thiamin (mg)
- Riboflavin (mg)
- Niacin (mg)
- Ascorbic acid (mg)
- Iodine (μg)
- Vitamin D (μg)
- Zinc (μg)
Measured: 2 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startOct 2010
- Primary completionDec 2010
- Study completionDec 2010
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 Bottle FeedingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010749
- Sponsor's protocol ID
- 9052A1-3001 PHL
- Status last verified
- Dec 2013
- First submitted
- 6 Nov 2013
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- 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 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Concentration in Infant Formula: A Follow-up Study of Growth at 2 Years of Age
- ClinicalTrials.gov ID
- NCT02010749
- Acronym / sponsor ID
- 9052A1-3001 PHL
- Conditions
- Bottle Feeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Dec 2013 (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.
The primary objective of the study was to compare the growth parameters of children approximately 2* years of age, who as infants were randomized to receive either a lower-protein formula ("experimental formula"; EF) with 12.8 g/L protein or a standard formula (SF) with 14.1 g/L protein or who were human milk (HM) fed for the first 4 months of life. The secondary objective was to describe diet and nutrient intake in this cohort of children. The exploratory objectives were to describe stool microbiota in a subset of this cohort and stool composition (stool soap and nonsoap fatty acids, total fatty acids, and minerals) in a second subset of this cohort.
(* The mean age of subjects was 33.0 months due to a delay in the study start-up.)
Detailed description
This was an observational, single-site, follow-up study of healthy children who as infants who had completed study 9052A1-3000. An attempt was made to contact all subjects who had completed study 9052A1-3000 by telephone to ask them to participate in study 9052A1-3001. Approximately 66 and 60 subjects were planned to participate in the stool microbiota and stool composition substudies, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Control: Children who had received Standard formula (SF) as infants |
| Experimental | – | –Experimental: Children who had received lower protein formula as infants |
Who may qualify
- Ages
- 2 to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children 2 years of age who were enrolled in the Wyeth Nutrition study
Key inclusion criteria (1 listed)
- Children who were enrolled in the Wyeth Nutrition study are eligible to participate in this study
Key exclusion criteria (3 listed)
- Children who were not enrolled in the Wyeth Nutrition study are not eligible to participate in this study
- Children who have received any antibiotics and antifungal medications except topical within two weeks prior to enrollment are not eligible to participate in the stool microbiota study
- Children who are taking any medications known or suspected to affect fat digestion, absorption, and or metabolism, any vitamin and or mineral supplements which contain calcium, suppositories, bismuth-containing medications, herbal supplements, or medications that may neutralize or suppress gastric acid secretion, are not eligible to participate in the stool composition study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Weight-for-Length Z-Scores
Time frame: 2 years of age
Primary Efficacy Endpoint: weight-for-length Z-score based on World Health Organization (WHO) growth charts.
6 secondary outcomes
Weight-for-age Z-score
Time frame: 2 years of age
Length-for-age Z-score
Time frame: 2 years of age
Head circumference-for-age Z-score
Time frame: 2 years of age
BMI-for-age Z-score
Time frame: 2 years of age
Dietary intake
Time frame: 2 years of age
Nutrient intake
Time frame: 2 years 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 13 Dec 2013.
- 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.
Related trials for Bottle Feeding
Recruiting
The Bottle Optimization Testing Tiny Little Eaters Study
Childhood Obesity
RecruitingPhase 2/3
BabySTrong II taVNS Feeding Trial
Feeding Delays, Neonates and Term Infants
Recruiting
Positive Feeding of the Preterm Infant
Preterm Infant, Breast Feeding
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bottle Feeding, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.
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 1 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 13 Dec 2013. 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 Philippines. 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?
Weight-for-Length Z-Scores (time frame: 2 years of age). 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 NCT02010749, 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 13 Dec 2013.