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Completed

NCT Number: NCT02156986

Chewing Capability Study for Infants and Toddlers

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.

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Key information

Conditions

Healthy

Age range

9 month–36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

MGH Institute of Health Professions

Boston, Massachusetts, 02129-4557, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Muscle activities involved in the mastication using Electromyography (EMG)

    Time frame: One day during the study visit 2

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Effect of Food Structural Properties on Infants and Toddlers Mastication Abilities

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 5, 2014
Registry last updated
Aug 5, 2014

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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