Effect of Nutritional Intervention on Metabolic Response in Infants

NCT ID: NCT04483453

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2021-06-09

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

EXPL feeding regimen

Lower protein / lower estimated glycemic index regimen

Group Type: EXPERIMENTAL

EXPL feeding regimen

Intervention Type: OTHER

EXPL FUF (lower protein and 100% lactose) + EXPL IC (whole grains and legumes)

CTRL feeding regimen

Standard protein / standard glycemic index regimen

Group Type: ACTIVE_COMPARATOR

CTRL feeding regimen

Intervention Type: OTHER

CTRL FUF (standard protein content and carbohydrate profile) + CTRL IC (refined grains)

Interventions

EXPL feeding regimen

EXPL FUF (lower protein and 100% lactose) + EXPL IC (whole grains and legumes)

Intervention Type: OTHER

CTRL feeding regimen

CTRL FUF (standard protein content and carbohydrate profile) + CTRL IC (refined grains)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Written informed consent has been obtained from both parent / liable parent or legally acceptable representative (LAR), if applicable

2. Healthy infant who was singleton, full-term gestational birth (≥ 37 completed weeks of gestation) with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg

3. Infant is no longer breastfeeding or receiving breast milk, has not yet started FUF, and is developmentally ready to begin complementary feeding

4. Infant's parent(s)/guardian is of legal age of consent, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol.

5. At screening visit (visit 0), infant is 24 - 26 weeks (5½ - 6 months) old

6. Weight-for-height value >-2 standard deviations from the WHO Child Growth Standards median

Exclusion Criteria

1. Chronic infectious, metabolic, or other disease including any condition that in the opinion of the investigator may impact feeding, growth or adherence to study procedures

2. Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)

3. Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, gluten sensitivity or severe food allergies that impact diet

4. Born to mothers with gestational diabetes or type 1 diabetes

5. Major medical/surgical event requiring prolonged hospitalization during the first 6 months

6. Receiving or having received insulin, growth hormone or any other medication known to affect glucose or carbohydrate metabolism or pre- or probiotics known to affect fecal microbiota prior to enrollment

7. Subjects or subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol

8. Currently participating or having participated in another clinical trial within 4 weeks prior to trial start

• Minimum Eligible Age: 24 Weeks
• Maximum Eligible Age: 26 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Las Piñas Doctors Hospital

Las Piñas, , Philippines

Countries

Philippines

Other Identifiers

18.17.INF

Identifier Type: -

Identifier Source: org_study_id