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Infant Nutrition SciencesACERNCT02781298

Acceptability, Tolerance, Satiety and Prebiotic Effect of a New Infant Cereal

A study testing New Infant Cereal and Multicereals Infant Cereal in people with Infant Nutrition Sciences, run by Hero Institute for Infant Nutrition at 4 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates a new infant cereals on acceptability, tolerance, satiety and prebiotic effect in infants. Read more about this study

Who is it for?
Ages 5 to 6 monthsHealthy volunteers can take part
Conditions the study is for
Infant Nutrition Sciences
What is being tested?
New Infant Cereal and Multicereals Infant Cereal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
4 sitesSpain
Study dates
Dec 2014to Feb 2017
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 5 to 6 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy term infant
  • Birth weight 2500-4200 g
  • Tolerance to cow's milk
  • Tolerance to lactose
  • No Breastfeeding at least 4 months of age
  • No use antibiotic at least 2 weeks before recruitments

Who cannot join

  • Intolerance to gluten (celiac disease)
  • Congenital abnormalities
  • Acute diseases
  • Chronic situation that affect to food intake or metabolism
  • Breastfeeding infant
  • Any food allergy
  • Participation in other study

Trial locations and contacts

4 sites in 1 country.

Spain4 sites

  • Institute Hero for Infant Nutrition

    Alcantarilla, Murcia, 30820

  • Quantum Experimental

    Murcia, Murcia, 30010

  • University of Murcia

    Murcia, Murcia, 30100

  • Hospital Virgen de la Arrixaca

    Murcia, Murcia, 30120

Other trials in Spain

About this study

Official title: Acceptability, Tolerance, Satiety and Prebiotic Effect of a New Infant Cereal in Infant Between 5 and 8 Months of Age, at the Beginning of Complementary Feeding

This study evaluates a new infant cereals on acceptability, tolerance, satiety and prebiotic effect in infants.

Read the detailed description

This is a controlled, randomized, prospective, crossover, triple-blind study to evaluate of a new infant cereal with a portion of whole grain flour on sensorial acceptability, gastrointestinal tolerance, satiety and prebiotic effect in healthy infants fron 5 to 8 months of age at the beginning of complementary feeding.

Being tested
New Infant Cereal, Multicereals Infant Cereal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • New Infant CerealDietary supplement

    The infants will start the complementary feeding with the infants cereals of this study, the amount of cereal ingested will be free according to pediatricians recommendations.

  • Multicereals Infant CerealDietary supplement

    The infants will start the complementary feeding with the infants cereals of this study, the amount of cereal ingested will be free according to pediatricians recommendations.

Study groups in NCT02781298
Study groupRoleWhat they receive
New Infant CerealExperimentalamount ingested according to pediatricians recommendations
Receives: Dietary Supplement: New Infant Cereal; Dietary Supplement: Multicereals Infant Cereal
Multicereals Infant CerealActive comparatoramount ingested according to pediatricians recommendations
Receives: Dietary Supplement: New Infant Cereal; Dietary Supplement: Multicereals Infant Cereal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hedonic scale- Sensorial Evaluation

    Sensorial acceptability -Differences between groups measured by Hedonic scales (4-points for children and 7-points for adults)

    Measured: Day 24, day 73

Secondary outcomes (7)

  1. Weight

    Weight (g)

    Measured: Day 1 (Baseline), Day 45, day 93.

  2. Length

    Length (cm)

    Measured: Day 1 (Baseline), Day 45, day 93.

  3. Head Circumference

    Head Circumference (cm)

    Measured: Day 1 (Baseline), Day 45, day 93.

  4. Gastrointestinal tolerance

    Numbers of Regurgitations, gassiness, rejections- Differences between groups measured by a 1-day record

    Measured: Day 7, day 24, day 45, day 52, day 73, day 93

  5. Intestinal habits

    Frequency of defecations and stools consistency- Differences between groups measured by 1-day record

    Measured: Day 7, day 24, day 45, day 52, day 73, day 93

  6. Satiety

    Food intake (amount), crying (time) and sleeping (time)-Differences between groups measured by 1-day record

    Measured: Day 7, day 24, day 45, day 52, day 73, day 93

  7. Prebiotic effects

    Microbiome sequencing- Differences between groups measured in collected stools

    Measured: Day 1 (baseline), day 45

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2016 (estimated)
  2. Study startDec 2014
  3. Primary completionFeb 2017
  4. Study completionFeb 2017

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02781298
Sponsor's protocol ID
CT09-14
Acronym
ACER
Status last verified
Feb 2017
First submitted
9 May 2016
Last updated
23 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Bernal MJ, Periago MJ, Martinez R, Ortuno I, Sanchez-Solis M, Ros G, Romero F, Abellan P. Effects of infant cereals with different carbohydrate profiles on colonic function--randomised and double-blind clinical trial in infants aged between 6 and 12 months--pilot study. Eur J Pediatr. 2013 Nov;172(11):1535-42. doi: 10.1007/s00431-013-2079-3. Epub 2013 Jun 29.

    PubMed 23812516

  • Fardet A. New hypotheses for the health-protective mechanisms of whole-grain cereals: what is beyond fibre? Nutr Res Rev. 2010 Jun;23(1):65-134. doi: 10.1017/S0954422410000041. Epub 2010 Jun 22.

    PubMed 20565994

  • Stephen A, Alles M, de Graaf C, Fleith M, Hadjilucas E, Isaacs E, Maffeis C, Zeinstra G, Matthys C, Gil A. The role and requirements of digestible dietary carbohydrates in infants and toddlers. Eur J Clin Nutr. 2012 Jul;66(7):765-79. doi: 10.1038/ejcn.2012.27. Epub 2012 Apr 4.

    PubMed 22473042

  • Mennella JA, Trabulsi JC. Complementary foods and flavor experiences: setting the foundation. Ann Nutr Metab. 2012;60 Suppl 2(Suppl 2):40-50. doi: 10.1159/000335337. Epub 2012 Apr 27.

    PubMed 22555188

Questions about this trial

What is this clinical trial studying?

A study testing New Infant Cereal and Multicereals Infant Cereal in people with Infant Nutrition Sciences, run by Hero Institute for Infant Nutrition at 4 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 6 inclusion and 7 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

Hedonic scale- Sensorial Evaluation (time frame: Day 24, day 73). 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 NCT02781298, which also lists 4 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 23 Feb 2017.

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