Oral Nutritional Supplementation in Children

Abbott

Status: Terminated

Conditions: Children

Treatments: Other: Nutritional Supplement and Counseling; Other: Counseling

Study type: Interventional

Funder types: Industry

Identifiers

NCT02125123

AL15

Details and patient eligibility

About

This study will investigate the effect of an oral nutritional supplement (ONS) along with dietary counseling on improving the dietary intake among children with picky eating behaviors.

Enrollment: 26 patients

Sex: All

Ages: 36 to 109 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. ≥ 36 months and < 109 months of age.
2. Healthy and not suffering from any physical disability.
3. Height-for-age and BMI-for-age between the 5th and the 95th percentile; weight-for-age between the 5th and the 85th percentile.
4. Capable of oral feeding.
5. Has a mean score of greater than 3.0 on the fussiness category in the Children's Eating Behaviour Questionnaire and also consumes on average less than the daily recommendations for at least 3 of 5 food groups (Dietary Guidelines for America, 2010).
6. Willing to abstain from consuming non-study nutritional supplements during the study intervention period.

Exclusion criteria

1. History of an acute or chronic condition that may affect feeding habits or nutritional status.
2. Taking any medications or nutritional supplements on a daily basis for more than 2 weeks during the past month that may profoundly affect feeding habits or nutritional status.
3. Clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement.
4. Any acute/chronic condition requiring medical treatment which may include hospitalization.
5. Allergy or intolerance to any ingredient in the study product.
6. Gastrointestinal infection, acute constipation or acute diarrhea.
7. Hepatitis B or C, or HIV, or malignancy.
8. Congenital cardiac defects.
9. Dysphagia, aspiration risk or difficulty in swallowing due to acquired/congenital abnormalities.
10. Parent(s)/LG of the subject has any clinically significant medical disease or physical/psychological condition that may interfere with protocol adherence or ability of the parent(s)/LG to give informed consent.

Trial design

26 participants in 2 patient groups

Nutritional Supplement and Counseling

Experimental group

Description:

Two servings a day; ready-to-feed nutritional supplement plus dietary counseling

Treatment:

Other: Nutritional Supplement and Counseling

Counseling

Active Comparator group

Description:

Dietary Counseling

Treatment:

Other: Counseling