Chewing Capability Study for Infants and Toddlers

Effect of Food Structural Properties on Infants and Toddlers Mastication Abilities

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.

Study Overview

• Status: Completed
• Conditions: Healthy

• Study Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02129-4557
      • MGH Institute of Health Professions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 3 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The subjects investigated will be healthy infants and toddlers ranging from 9 to 36 months in 5 groups:

• 9 months (±2 weeks),
• 12 months (±1 month),
• 18 months (±2 months),
• 24 months (±2 months),
• 36 months (±3 months).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
9 month old infant
12 month old infant
18 month old toddler
24 month old toddler
36 month old toddler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Muscle activities involved in the mastication using Electromyography (EMG)	One day during the study visit 2

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: June 4, 2014
• First Submitted That Met QC Criteria: June 4, 2014
• First Posted (Estimate): June 5, 2014

Study Record Updates

• Last Update Posted (Estimate): August 5, 2014
• Last Update Submitted That Met QC Criteria: August 4, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 13.03.INF