Infant DevelopmentCEOBENCT02165956
Effect of a New Infant Cereal on Weight Gain
A study testing New Infant Cereal and Standard Infant Cereal in people with Infant Development, run by Laboratorios Ordesa at 5 sites in Spain.
Trial summary
The purpose of this study is to determine whether a new infant cereal has an effect on weight gain and intestinal microbiota compared to a standard cereal in healthy infants . Read more about this study
- Who is it for?
- Ages 6 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- New Infant Cereal and Standard Infant Cereal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 5 sitesSpain
- Study dates
- Mar 2011to Apr 2013
- 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 6 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Lactating babies
- 6 months of age
- Informed consent signed by parents
Who cannot join
- Malformations, diseases or conditions that may alter development and/or nutritional status
- Born very and extremely preterm (<32 weeks of gestational age)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Centro de Salud Santo Grial
Huesca, 22003
Centro de Salud Perpetuo Socorro
Huesca, 22006
Centro de Salud Isabel II-Centro
Santander, 39002
Centro de Salud El Alisal
Santander, 39011
Consultorio de Soto de la Marina
Soto de la Marina, Cantabria, 39110
About this study
Official title: Effect of a New Food Product on Weight Gain During First Infancy
The purpose of this study is to determine whether a new infant cereal has an effect on weight gain and intestinal microbiota compared to a standard cereal in healthy infants .
Read the detailed description
This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of a new infant cereal supplemented with prebiotics, probiotics, vegetable proteins and a special blend of starches on weight gain and intestinal microbiota in healthy infants from 6 to 12 moths of age. Patients will be randomized to receive either the new infant cereal or a standard cereal.
- Conditions
- Infant Development
- Being tested
- New Infant Cereal, Standard Infant Cereal
- Keywords
- Cereals, Obesity, Complementary Feeding
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Infant CerealDietary supplement
New Infant Cereal
Standard Infant CerealDietary supplement
Standard Infant Cereal
| Study group | Role | What they receive |
|---|---|---|
| New Infant Cereal | Experimental | The amount of cereal administered will be free and from 6 to 12 months of age. Receives: Dietary Supplement: New Infant Cereal |
| Standard Infant Cereal | Active comparator | The amount of cereal administered will be free and from 6 to 12 months of age. Receives: Dietary Supplement: Standard Infant Cereal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in nutritional status
Difference between groups measured by a composite of nutritional parameters(weight, height, perimeters and skin fold measurements).
Measured: At 6, 9, 12, 15 and 18 months of age
Secondary outcomes (3)
Changes in appetite
Differences between groups measured by a 3-day food record.
Measured: At 6, 9, 12, 15 and 18 months of age
Tolerability of study product
Differences between groups measured by frequency and type of a composite of gastrointestinal symptoms (regurgitation, irritability, flatulence and crying).
Measured: At 6, 9, 12, 15 and 18 months of age
Changes in intestinal microbiota
Differences between groups measured by the analysis of faecal samples.
Measured: At 6, 9, 12 and 18 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 posted18 Jun 2014 (estimated)
- Study startMar 2011
- Primary completionApr 2012
- Study completionApr 2013
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 DevelopmentStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Ordesa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luis Alberto Moreno, Professor, Principal investigator, Universidad de ZaragozaGerardo Rodríguez, Professor, Principal investigator, Universidad de ZaragozaMª Luisa Álvarez, Principal investigator, Universidad de ZaragozaMª Jesús Cabero, Principal investigator, University of CantabriaLaura Monje, Principal investigator, University of Cantabria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165956
- Sponsor's protocol ID
- CEOBE-01-011
- Acronym
- CEOBE
- Status last verified
- Jul 2019
- First submitted
- 11 Jun 2014
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Rodríguez G, Cabero MJ, Samper P, Álvarez ML, Monje L, Morera M, Rivero M, García-Fuentes M, Moreno L. Complementary feeding and infant body composition in northern Spain. Ann Nutr Metab. 2013;63 (suppl 1):1-1960. PO908.
Rodriguez G, Cabero MJ, Morera M, Samper P, Álvarez ML, Monje L, Moreno L, García-Fuentes M, Rivero M. Intake pattern of infant complementary feeding in two populations in Northern Spain. JPGN. 2013;56(Suppl 2):486. PO-N-0283.
Morera M, Rodríguez G, Cabero MJ, Samper P, Álvarez ML, Monje L, Miralles A, Álvarez L, Rivero M, García-Fuentes M, Moreno L. Rapid weight gain during complementary feeding period and overweight risk. JPGN. 2014;58(Suppl 1):456. PO-N-0274.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a New Food Product on Weight Gain During First Infancy
- ClinicalTrials.gov ID
- NCT02165956
- Acronym / sponsor ID
- CEOBE / CEOBE-01-011
- Conditions
- Infant Development
- Keywords
- Cereals, Obesity, Complementary Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Laboratorios OrdesaIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 Jun 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.
The purpose of this study is to determine whether a new infant cereal has an effect on weight gain and intestinal microbiota compared to a standard cereal in healthy infants .
Detailed description
This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of a new infant cereal supplemented with prebiotics, probiotics, vegetable proteins and a special blend of starches on weight gain and intestinal microbiota in healthy infants from 6 to 12 moths of age. Patients will be randomized to receive either the new infant cereal or a standard cereal.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Infant Cereal | Experimental | Dietary Supplement: New Infant CerealThe amount of cereal administered will be free and from 6 to 12 months of age. |
| Standard Infant Cereal | Active comparator | Dietary Supplement: Standard Infant CerealThe amount of cereal administered will be free and from 6 to 12 months of age. |
Who may qualify
- Ages
- 6 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Lactating babies
- 6 months of age
- Informed consent signed by parents
Key exclusion criteria (2 listed)
- Malformations, diseases or conditions that may alter development and/or nutritional status
- Born very and extremely preterm (<32 weeks of gestational age)
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 |
|---|---|---|
| New Infant CerealNew Infant Cereal | Dietary supplement | New Infant Cereal |
| Standard Infant CerealStandard Infant Cereal | Dietary supplement | Standard Infant Cereal |
Primary outcome
Changes in nutritional status
Time frame: At 6, 9, 12, 15 and 18 months of age
Difference between groups measured by a composite of nutritional parameters(weight, height, perimeters and skin fold measurements).
3 secondary outcomes
Changes in appetite
Time frame: At 6, 9, 12, 15 and 18 months of age
Tolerability of study product
Time frame: At 6, 9, 12, 15 and 18 months of age
Changes in intestinal microbiota
Time frame: At 6, 9, 12 and 18 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 19 Jul 2019.
- Results publicationRodríguez G, Cabero MJ, Samper P, Álvarez ML, Monje L, Morera M, Rivero M, García-Fuentes M, Moreno L. Complementary feeding and infant body composition in northern Spain. Ann Nutr Metab. 2013;63 (suppl 1):1-1960. PO908.
- Results publicationRodriguez G, Cabero MJ, Morera M, Samper P, Álvarez ML, Monje L, Moreno L, García-Fuentes M, Rivero M. Intake pattern of infant complementary feeding in two populations in Northern Spain. JPGN. 2013;56(Suppl 2):486. PO-N-0283.
- Results publicationMorera M, Rodríguez G, Cabero MJ, Samper P, Álvarez ML, Monje L, Miralles A, Álvarez L, Rivero M, García-Fuentes M, Moreno L. Rapid weight gain during complementary feeding period and overweight risk. JPGN. 2014;58(Suppl 1):456. PO-N-0274.
- IUNS 2013 Congress - Abstract Book - Ann Nutr Metab. 2013;63 (suppl 1):1-1960Link provided by the sponsor.
- ESPGHAN 2014 Annual Meeting - Abstracts Book - JPGN. 2014;58(Suppl 1):456.Link provided by the sponsor.
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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.
Luis Alberto Moreno, Professor principal investigator
Universidad de Zaragoza
Gerardo Rodríguez, Professor principal investigator
Universidad de Zaragoza
Mª Luisa Álvarez principal investigator
Universidad de Zaragoza
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Infant Cereal and Standard Infant Cereal in people with Infant Development, run by Laboratorios Ordesa at 5 sites in Spain.
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 2 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 19 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 5 sites in Spain. 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?
Changes in nutritional status (time frame: At 6, 9, 12, 15 and 18 months 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 NCT02165956, 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 19 Jul 2019.