Treatment Trials

12 Clinical Trials for Various Conditions

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TERMINATED
Baylor Infant Biomarker of Nutrition Study
Description

The study evaluates the the utility of a non-invasive skin measurement as a biomarker of infant food intake during complementary feeding.

COMPLETED
The Effects of Natural Sugars in Breast Milk on Healthy Infant Growth and Development
Description

This study will investigate the effects of breastfeeding and breastmilk composition on infant gut microbiome development as well as obesity and cognitive outcomes. Breast milk contains certain natural sugars that can promote the growth of 'good' bacteria in the intestines and reduce the growth of harmful bacteria. The purpose of this study is to look at the effects of these natural sugars in breast milk on the infant's bacteria and the impact of this on development of obesity and cognitive outcomes by 2 years of age with plans for longer term follow up contingent upon funding.

Conditions
COMPLETED
Infant Nutrition and Brain Development
Description

Research study on the role of early life nutrition on brain and cognitive development during infancy and early childhood. Two blends of myelin-relevant nutrients at different levels were compared and a breastfed group was considered as epidemiological reference.

ACTIVE_NOT_RECRUITING
Study of Early Infant Diet on Growth and Development
Description

The purpose of this study is to characterize physical growth, body composition, dietary intake, neurobehavioral development, and brain function of infants and children fed mostly breast-milk, milk-based formula or soy-based formula during their first year of life. Children are followed from age 2 months to age 6 years.

Conditions
COMPLETED
Healthy Eating for My Infant (HEMI)
Description

Infants from underserved and minority backgrounds are at increased risk for obesity and poor feeding and nutrition outcomes, but obesity prevention programs tailored specifically to the needs of these infants are lacking. The current study takes a community-engaged approach to development and delivery of an adaptively tailored obesity prevention program delivered via home visiting to target infant eating and feeding (Healthy Eating for My Infant; HEMI).

COMPLETED
Evaluation of Cow Milk-Based Formulas - Functional Proteins
Description

The purpose of this study is to look at the function of infant formula components to optimize the nutritional content and functionality of a marketed routine infant formula.

Conditions
RECRUITING
Baylor Infant and Toddler Biomarker of Nutrition Study
Description

Young children rely on their foods and drinks for the nutrients they need to grow, like energy, protein, vitamins, and minerals. In addition to nutrients, there are substances in fruits, vegetables, milk and formula, called phytochemicals, that can support health. While researchers know more about the role of phytochemicals in adult health, researchers know surprisingly little about how phytochemicals can support health in young children. One group of phytochemicals are called the carotenoids. Carotenoids are responsible for the red, orange, and yellow colors in some fruits and vegetables. In adults, carotenoids can support visual function. Researchers also know that measuring levels of carotenoids in the blood or optically in the skin, can serve as an indirect measurement of what child and adults eat. The purpose of this study is to determine how a child's usual intake of carotenoids is related to their visual development and their blood and skin levels of carotenoids. The study involves 6 visits. For each visit, we will ask about the child's recent diet, will measure their body size, collect a blood sample, collect optical measurements of their skin, and will test how sharp their vision is.

UNKNOWN
Investigating the Effects of Nutrition on the Maturation of Brain Networks Associated With Memory in Infants
Description

This project will investigate whether adding nutritional supplements to the diet will have beneficial effects on the development of infant brain networks (assessed at 4 and 9 months of age). The nutritional supplement will contain lutein (typically found in leafy vegetables),docosahexaenoic acid (DHA; a fatty acid typically found in cold-water fish such as salmon or tuna), and of vitamin E.

Conditions
ACTIVE_NOT_RECRUITING
Infant Diet Effects on Brain Function and Language Processing (fMRI)
Description

The purpose of this study is to identify neurocognitive functions and language processing of 8-year-old children who were fed either breast milk, milk-based formula or soy-based formula during the first year of life.

Conditions
COMPLETED
Sensitive Periods in Early Flavor Learning
Description

Flavor is the primary dimension by which young children determine food acceptance. However, children are not merely miniature adults since sensory systems mature postnatally and their responses to certain tastes differ markedly from adults. Moreover, emerging research has revealed that there are sensitive periods during infancy such that early flavor experiences serve to modify later responses to flavors and foods. The proposed study aims to investigate this important issue by using as a model system a class of infant formulas which are hydrolyzed protein based and thus have very pronounced and distinctive flavors which are unpalatable to older-aged infants and adults. This research was initiated because of anecdotal reports by pediatricians that although it is easy to introduce this type of formula to infants during the first months of life, it becomes extremely difficult to do so later in infancy. Indeed, recent studies in the investigators' laboratory provided the first experimental demonstration that infants younger than 4 months of age willingly accept substantial amounts of, and satiate while feeding, a novel, protein hydrolysate formula. In marked contrast, infants older than 4 months reject the protein hydrolysate formula and this rejection occurs within the first minute of a feed, a finding that strongly suggests the sensory qualities of the formula are responsible, at least in part, for this rejection. Moreover, this rejection is not evident when the investigators test older-aged infants with other unfamiliar, but non-hydrolysate, formulas. In other words, the rejection appears to be in response to a particular component or components of protein hydrolysate formulas. This shift in acceptability can be ameliorated by prior exposure. That is, if these formulas are introduced to infants within the first few months of life and are fed continuously, they remain highly acceptable throughout infancy and early childhood. These observations implicate a sensitive period during development, occurring somewhere before 4 months of age, during which exposure to a formula, which is unpalatable to adults and infants over 4 months of age without exposure, renders it acceptable and presumably palatable. To the investigators' knowledge, this is the clearest example of a sensitive period in the development of responses to foods and flavors in humans thus far identified. There is a paucity of information on whether and how the composition of formulas fed to infants influences their short-term feeding behaviors during the first few months of life. The primary objective of this longitudinal study is to determine the period during early infancy when exposure to the casein-hydrolysate formula, Nutramigen, renders it acceptable during later infancy. The study also aims to determine how early sensory experiences with formula impact upon food acceptance during infancy (8-9 months of age) and childhood. The investigators will also explore how variation in the genes that encode for taste receptors influence preferences for foods and other behaviors.

Conditions
COMPLETED
Bioavailability and Dosing of a Monosaccharide Supplement in Adults
Description

We are developing an oral supplement of carbohydrates to be added to infant formulas in order to improve brain development, immune function, and overall health of infants and children. After a careful review of what is known about these sugars, there is very little information regarding their use in infants and children, although there is some information in adults and animals. Many of these sugars have been used in a glyco-nutritional supplement in adults and children, with minimal or no reported side effects. We are developing a custom blend of important individual sugars, and need information regarding their dosing and blood concentrations following oral intake of the carbohydrate supplement. Timed blood samples following the carbohydrate supplement will provide us with a better understanding of the most effective dose and the metabolism of these sugars in adults. This will give us the preliminary information we need for developing an oral supplement of special sugars that can be added to infant formulas to help improve brain development and immune function in infants and children.

Conditions
WITHDRAWN
Study of Body Composition Methodology in Young Children (InfantPod)
Description

The InfantPod study is a cross-sectional study designed to determine how practical and precise a body composition method is for measuring body fat and lean tissue in infants and children ages 5 months to 3 years.

Conditions