Oral Nutritional Supplementation in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Nutritional Supplement and Counseling

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

Group Type EXPERIMENTAL

Nutritional Supplement and Counseling

Intervention Type OTHER

Ready-to-feed nutritional supplement and dietary counseling

Counseling

Dietary Counseling

Group Type ACTIVE_COMPARATOR

Counseling

Intervention Type OTHER

Dietary counseling

Interventions

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Nutritional Supplement and Counseling

Ready-to-feed nutritional supplement and dietary counseling

Intervention Type OTHER

Counseling

Dietary counseling

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

36 Months

Maximum Eligible Age

109 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes