Regulation and Mechanism of New Compound Functional Ingredients in Infants

NCT05297006 | Unknown

• 1 other identifier: S170003
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 3

Brief Summary

A prospective, multicentre, randomized, double-blind, parallel control study was conducted to analyze the changes in growth, intestinal flora, and immune function of infants with different feeding patterns from postnatal to 1 year of age.

Conditions

Sialic Acid; Oligosaccharide

Keywords

Infant; Human milk; Growth and development; immune level

Outcome Measures

Primary Outcomes (5)

• Growth and development indexes

  Baby body length, weight, head circumference gain

  12 months

• Growth and development indexes

  Baby body weight gain

  12 months

• Growth and development indexes

  Baby body head circumference gain

  12 months

• Neurodevelopmental level

  The Peabody scale was used to assess the level of neural development of infants at 4 months and 6 months

  4 months

• Neurodevelopmental level

  The Peabody scale was used to assess the level of neural development of infants at 6 months

  6 months

Study Arms (3)

Breastfeeding group

The mother can breastfeed exclusively until the infants is at least 4 months old, after which complementary foods are added scientifically according to the baby's condition.

Formula group containing new compound functional ingredients

Only use formula milk powder containing oligosaccharides, sialic acid and other ingredients feed the infants for at least 4 months, and then complementary food is added scientifically according to the infant's condition.

Dietary Supplement: The infants who drank milk powder were given a dietary intervention four months before

Formula group without new compound functional ingredients

Only use formula milk powder without oligosaccharides, sialic acid and other ingredients feed the infants for at least 4 months, and then complementary food is added scientifically according to the infant's condition.

Dietary Supplement: The infants who drank milk powder were given a dietary intervention four months before

Interventions

The infants who drank milk powder were given a dietary intervention four months before DIETARY_SUPPLEMENT

The infants who eat milk powder were randomly divided into two groups: group containing new compound functional ingredients and group without new compound functional ingredients

Formula group containing new compound functional ingredients; Formula group without new compound functional ingredients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Breastfeeding group The mother can breastfeed exclusively until the infants is at least 4 months old, after which complementary foods are added scientifically according to the baby's condition. Formula group containing new compound functional ingredients Only use formula milk powder containing oligosaccharides, sialic acid and other ingredients feed the infants for at least 4 months, and then complementary food is added scientifically according to the infant's condition. Formula group containing new compound functional ingredients Only use formula milk powder containing oligosaccharides, sialic acid and other ingredients feed the infants for at least 4 months, and then complementary food is added scientifically according to the infant's condition.

You may qualify if:

• Healthy infants;
• Full-term (gestational age ≥37 weeks);
• Birth weight 2500-4500g;
• Mothers have no history of diabetes, hypertension, heart disease, and other diseases during pregnancy;
• The guardian signed informed consent and voluntarily enrolled into the group and promised to complete systematic follow-up.

You may not qualify if:

• Hospitalization with cognitive impairment or deformity ≥2 days
• History of birth asphyxia (Apgar score \< 3)
• Severe allergy to milk and serious medical conditions such as intracranial hemorrhage, chronic diarrhea, necrotizing colitis, or acute infection
• The guardian refused to enroll or could not complete the system follow-up.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Peking University First Hospital: collaborator
• Peking University People's Hospital: collaborator

Study Sites (3)

Peking University People's Hospital

Beijing, Beijing Municipality, 100191, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Peking University First Hospital

Beijing, 100191, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

breast milk, infants' blood, infants' faeces

MeSH Terms

Interventions

Lead

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Central Study Contacts

Ying T Han

CONTACT

+8613661013288; hanying1568@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: March 25, 2022
• Study Start: April 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 25, 2022

Record last verified: 2022-03

Locations

CN (3)