NCT04483453

Effect of Nutritional Intervention on Metabolic Response in Infants

Effect of Nutritional Intervention on Metabolic Response in Infants: A Single-Blind, Randomized, Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 24 Weeks – 26 Weeks
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the glucose response of complementary feeding regimens consisting of two different follow-up formulas (FUFs) and infant cereals (ICs).

Detailed description

This is a prospective, randomized, single-blind, controlled, 2-arm parallel group trial in infants aged 6 months (26 weeks) at enrollment, who are no longer breastfed, and who are ready but have not yet started complementary feeding. They will be fed one of two different isocaloric feeding regimens (Experimental \[EXPL\] or Control \[CTRL\]) consisting of different follow-up formulas (FUFs) and infant cereals (ICs). The main purpose of this study is to determine the glucose response of these two different complementary feeding regimens. All enrolled infants will participate in the trial for approximately 6 months.

Conditions

• Infant Development
• Glucose, High Blood

Interventions

Type	Name	Description
OTHER	EXPL feeding regimen	EXPL FUF (lower protein and 100% lactose) + EXPL IC (whole grains and legumes)
OTHER	CTRL feeding regimen	CTRL FUF (standard protein content and carbohydrate profile) + CTRL IC (refined grains)

Timeline

• Start date: 2020-07-31
• Primary completion: 2021-04-29
• Completion: 2021-06-09
• First posted: 2020-07-23
• Last updated: 2021-10-05

Locations

1 site across 1 country: Philippines