Clinical Trials Directory

Trials / Completed

CompletedNCT04768933

Parental Notions and Clinical Experiences About Child's Gut Comfort, Overall Satisfaction and Sense of Well-being When Consuming a New Toddler Milk

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
Société des Produits Nestlé (SPN) · Industry
Sex
All
Age
12 Months – 33 Months
Healthy volunteers
Accepted

Summary

This is a prospective, open-label, single-arm study in a real-world setting of healthy Chinese toddlers provided with new toddler milk for a total of 4 weeks (28 days).

Detailed description

The new toddler milk contains prebiotic and an optimized fat blend of bovine milk fat, vegetable fats, and a LC-PUFA oil mixture (providing DHA and ARA). The prebiotic and bovine milk fat-based blend have shown to be able to improve digestive comfort and milk taste. Physiological factors such as physical discomfort has been shown to be associated with negative emotionality and temperament (Putnam 2012). Therefore, the investigators hypothesize that by improving digestive comfort, they are able to influence child temperament, happiness, and other behavioral characteristics.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTToddler MilkAt least three 130 mL servings daily of study formula are recommended for a total daily intake of 390 mL. Study participants will continue this feeding regimen Days 4 to 28 (approximately 4 weeks).

Timeline

Start date
2020-10-11
Primary completion
2020-11-28
Completion
2020-12-12
First posted
2021-02-24
Last updated
2021-02-24

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT04768933. Inclusion in this directory is not an endorsement.