Chewing Capability Study for Infants and Toddlers

Completed

• Conditions: Healthy

• Registration Number: NCT02156986
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

The main objective of the study is to conduct a pilot study on the characterization of the mastication abilities of infants and toddlers using different commercial cereal based products in order to gain knowledge and be able to plan future studies.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-06-04
• Study First Submitted QC: 2014-06-04
• Study First Posted: 2014-06-05
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-04
• Last Update Posted: 2014-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Born at term (37+ weeks)
• Familiar with solid foods
• No known history of food allergies
• Child must be within 2 weeks of the targeted age group for 9 months, within 1 month for 12 months, within 2 months for 18 and 24 months, and within 3 months for 36 months for this study.
• English must be the primary language of the participant and family.
• Having obtained his/her caregiver's or legal representative's informed consent.

Exclusion Criteria

• History of speech/language, cognitive, or physical impairments as indicated on the self-reported medical history questionnaire completed by caregiver or legal guardian
• Any previously undiagnosed speech/language or cognitive impairment detected by the Investigator. In the case a subject is identified as being at risk for a communication or feeding impairment, the caregiver will be notified and provided with a list of local speech-language pathology providers who could perform a formal assessment
• History of poor weight gain/ weight loss, food allergies, difficulties with sucking, difficulties with chewing and/ or swallowing, frequent drooling (for age groups 18, 24, and 36 months), frequent choking, gastro-esophageal reflux, frequent spitting up/ vomiting (for age groups 18, 24, and 36 months) or irritability after feedings/ eating
• Latex allergies
• Currently participating in or having participated in a similar clinical trial related to food/diet within the last 9 months
• Caregiver must not be under the age of 18 years old.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Muscle activities involved in the mastication using Electromyography (EMG)	One day during the study visit 2

Trial Locations

Locations (1)

MGH Institute of Health Professions; 🇺🇸 Boston, Massachusetts, United States