A
OtherControl: base infant rice-based cereal with no added sugar
NCT Number: NCT07318506
The purpose of this study is to define the effects of different inclusions in infant cereals on the adaptation of oral motor behavior and skills displayed at a given age.
Interested in participating?
Request Info6 month–6 month
All sexes
Interventional
Not applicable
Instituto DYM S.A., Barcelona, Spain
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
1.1. [182-242]-days of age from V1 to last visit for the 6-8-month-old age group 1.2. [243-364]-days of age from V1 to last visit for the 8-12-month-old age group 1.3. [365-547]-days of age from V1 to last visit for the 12-18-month-old age group 1.4. [548-730]-days of age from V1 to last visit for the 18-24-month-old age group
Exclusion criteria
Control: base infant rice-based cereal with no added sugar
Test product: base infant rice-based cereal with age appropriate inclusions. Inclusion type 1 for 6-8 months age group; type 4 for 8-12 months age group; type 4 for 12-18 months age group; type 9 for 18-24 months age group.
Test product: base infant rice-based cereal with age appropriate inclusions. Inclusion type 2 for 6-8 months age group; type 5 for 8-12 months age group; type 6 for 12-18 months age group; type 10 for 18-24 months age group.
Test product: base infant rice-based cereal with age appropriate inclusions. Inclusion type 3 for 6-8 months age group; type 6 for 8-12 months age group; type 8 for 12-18 months age group; type 11 for 18-24 months age group.
Test product: base infant rice-based cereal with age appropriate inclusions. Inclusion type 7 for 8-12 months and 18-24 months age groups. Not applicable for 6-8 months and 18-24 months age group.
Time frame: Immediately after the product intake
Define the change in number of chews observed during consumption of infant cereals with or without different inclusions based on manual video coding
Time frame: Immediately after the product intake
Comparer chewing duration extracted from video manual coding and the Baby FaceReader automatically calculated metrics between products with different textures for each age group.
Time frame: Immediately after the product intake
Comparer chewing rate extracted from video manual coding and the Baby FaceReader automatically calculated metrics between products with different textures for each age group.
Time frame: Immediately after the product intake
Comparer the observation of tongue lateral movements extracted from video manual coding and the BabyFaceReader automatically calculated metrics between products with different textures for each age group, using a 3 points categorical scale.
Time frame: Immediately after the product intake
Comparer the observation of rotary chewing motions extracted from video manual coding and the Baby FaceReader automatically calculated metrics between products with different textures for each age group, using a 3 points categorical scale.
Time frame: Immediately after the product intake
Identify specific correlation between product texture sensorial caracteristics data and number of chews for each age group, using Partial Least Squares Regression.
Time frame: Immediately after the product intake
Identify specific correlation between product texture mechanical caracteristics data and number of chews for each age group, using Partial Least Squares Regression.
Time frame: Immediately after the product intake
Comparer between product textures and according to the age group time to consume 5 spoons
Time frame: Immediately after the product intake
Comparer between product textures and according to the age group time to consume each individual spoon
Time frame: Immediately after the product intake
Comparer between product textures and according to the age group occurrence of positive and negative behaviors per session
Time frame: Immediately after the product intake
Comparer parents reported liking between product textures for each age group based on the score of liker scale responses (dislike extremely score to like extremely score).
Contact information is provided by the study sponsor or research team.
Société des Produits Nestlé (SPN)
Industry
Acronym: ICONIC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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