Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants

Официальное название

Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants: A Pilot Study

Обзор

The purpose of this research study is to understand how infants metabolize different meals and to develop clinical tools which identify infants as having two different phenotypes. The phenotypes are the 1) metabolic "thriftiness" and 2) the metabolic flexibility.

Подробное описание

The purpose of this research study is to understand how infants metabolize different meals and to develop clinical tools which identify infants as having two different phenotypes. This will be accomplished by providing two meal test stimuli to infant participants (human milk and infant formula). Energy expenditure and respiratory exchange ratio will be obtained before and after the meals to calculate the delta in both. From there, two phenotypes will be identified. The first phenotypes is metabolic "thriftiness", which will be defined by the energy expenditure after consuming two standard meals. The second phenotype is the degree of metabolic flexibility and will be defined by substrate oxidation (using respiratory exchange ratio) following two standard meals.

Вмешательства

• Другое Meal Test - Human Milk
  Infants will be fed a mixed meal test (meal challenge test) of human milk from his/her human milk donor (e.g., mother). Since all infants enrolled in the study consume human milk as a primary food source, this meal challenge test represents their standard meal, at a larger size. The meal test is provided inside a metabolic chamber to measure energy expenditure (VCO2 and VO2) before and after the meal. The amount of human milk that the infant is fed is estimated using the age and sex specific equ
• Другое Meal Test - Infant Formula
  Infants will be fed a mixed meal test (meal challenge test) of ready-to-feed infant formula. Since all infants enrolled in the study consume human milk as a primary food source, this meal challenge test represents a meal different from their habitual food intake and is a standard meal that all participants receive. The meal test is provided inside a metabolic chamber to measure energy expenditure (VCO2 and VO2) before and after the meal. The amount of infant formula that the infant is fed is est

Первичные конечные точки

• Energy expenditure difference from baseline to postprandial [Срок оценки: 60 minutes]
• Energy expenditure difference from baseline to postprandial (2) [Срок оценки: 60 minutes]

Вторичные конечные точки (2)

• Thrifty and Spendthrift Phenotypes [Срок оценки: 60 minutes]
• Metabolic flexibility [Срок оценки: 60 minutes]

Критерии участия

Критерии включения

• Aged 2 weeks to less than 17 weeks at screening
• Being fed human milk as a primary source of food
• Be willing to consume one meal of infant formula
• Be willing to complete a DXA measurement

Критерии исключения

• Unable to complete the screening visit and two clinic visits within 14 days
• Born with health conditions that would render procedures unsafe
• Born earlier than 35 days and 0 weeks gestation
• Eating supplemental foods
• Physician diagnosed feeding difficulties that may require a special type of nipple for bottle feeding

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 1 центр

• Pennington Biomedical Research Center — Baton Rouge

Идентификаторы

NCT: NCT07096011 · 2025-026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗