Clinical study of a new generation of powdered formulas that mimic breast milk lipids (OPO/OPL, MLCT)

Effects of MLTC-containing formula on lipid metabolism and growth of neonates

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400090360

Enrollment

Unknown

Registered

2024-09-29

Start date

2024-09-30

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Breastfeeding group:No intervention was implemented in the control group

MLCT group:Infants who need to be formula-fed within the first month of life are fed with infant formula containing new structural lipids until the age of 3 months.

Non-MLCT Group:Infants who need to be formula-fed within the first month of life and are fed with infant formulas that do not contain the new structural fats until the age of 3 months.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The research comprised healthy full-term babies delivered either vaginally or by cesarean section, who were given either breast milk, formula, or a combination of both (breast and formula feeding concurrently).

Exclusion criteria

Exclusion criteria: Exclusion criteria were prematurity (gestational age <37 weeks), low birth weight (<2500 g), maternal chronic diseases (e.g., type 1 or type 2 diabetes mellitus, inflammatory bowel disease), and maternal psychiatric and psychosomatic disorders.

Design outcomes

Primary

Measure	Time frame
Infant gut microbiota;Lipid metabolome in infant feces;	—

Secondary

Measure	Time frame
Weight;Height;Head circumference;Infants' ASQ (Ages and Stages Questionnaires) score;	—

Countries

China

Contacts

Public ContactCai Chenxi

School of Public Health, Xiamen University

chenxicai@xmu.edu.cn+86 592 218 6358

Outcome results