Clinical Research Directory

Baylor Infant and Toddler Biomarker of Nutrition Study

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.

Women Supporting Women to Improve Infant and Child Feeding Practices

Undernutrition in the first 2 years of life is the largest preventable cause of death before age 5. Among those who survive, stunting before age two leaves millions with lifelong physical and cognitive deficits, which are difficult to compensate for later in life. Pakistan is home to the second largest number of stunted children in South Asia. The primary goal of this study is to rehabilitate moderately malnourished children aged 7-23 months and enable mothers to sustain this healthy growth at home by changing their infant and young child feeding (IYCF) practices, child care, hygiene and health-seeking behaviours.

Sex Differences in Metabolism Following a High-fat Meal

Long-term consumption (i.e., several weeks to months) of a diet that is high in fat (\>35% daily calories from fat) is associated with the development of insulin resistance, a condition that can lead to a diagnosis of type 2 diabetes. Women tend to be better protected against the development of high-fat diet-induced insulin resistance compared with men, but it is not fully understand why this sex difference exists. It is possible that women metabolize high-fat meals differently than men, which might explain why they are less likely to develop type 2 diabetes over the course of their lifetime. However, no one has ever compared the metabolic response to a high-fat meal between men and women in the hours immediately after ingestion. During this study, the investigators will administer a single high-fat "fast-food" style breakfast meal (846 kcal, of which 58% is fat) to 24 health young adults (n=12 men, n=12 women) 18-35 years old. Their objective is to determine whether there are differences in the way men and women metabolize high-fat meals, such as this one. The research team will take regular blood samples after participants ingest this meal to measure features of glucose metabolism (e.g., blood glucose and insulin) as well as resting oxygen uptake (VO2) measurements to examine how much of this meal is burned for energy in the hours immediately after ingestion.

Intergenerational Mealtime at a Shared Site: A Small-scale Trial

The goal of this study is to find out whether having children and older people who attend an intergenerational center eating lunch together on a regular basis may be an improvement over continuing to eat lunch with their generational peers in separate dining rooms at the center. Specifically, the study analyzes the functioning and potential impact of an intergenerational dining room in terms of healthy eating, nutrition, self-evaluation of health and well-being, relational care, nutritional knowledge, and intergenerational attitudes. For this purpose, it sets up, in an intergenerational center, a dining room attended by children aged 2-3 years and older people aged 75 years and older who had previously been taking their lunch in separate dining rooms at the center. The main questions this study aims to answer are: * Does eating lunch at the intergenerational dining room improve the intake of healthy foods by children and older people compared to eating at their usual separate dining rooms with their peers? * Does this type of intergenerational dining room serve as a space for nutritional education of children and older people? * Does the experience of eating together have a positive influence in terms of children's attitudes towards older people and vice versa?

Health-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For Health

The purpose of this study is to assess whether introducing table olives into the diet results in health-related benefits for young adults. Several studies have shown that addition of olives as part of somebody's diet has a positive impact on cardiovascular, metabolic, and inflammatory factors. However, there have not been many studies among young, healthy adults. This study will compare levels of specific biomarkers, collected through blood draw, at the beginning of the study and after 5 weeks, to evaluate the effects of investigational daily olive consumption.

Water is K'é: Multi-level Intervention to Promote Healthy Beverage Choices Among Navajo Families

The goal of this clinical trial is to understand if a cultural intervention for Navajo families will improve healthy beverage habits, health outcomes, and family cohesion. The main questions it aims to answer are: * Does Water is K'é results in healthier beverage habits among children aged 2 to 5, compared with children in a control group? * Does the intervention improve the health of other family members? * How does the intervention affect family well-being? Participants will take part in a four-month program at the early child education site (such as a Head Start or the Bureau of Indian Affair's Family and Child Education or FACE Program) where the child is enrolled. They will take part in lesson plans, a social media campaign, and a family water access plan. Researchers will compare the participating families with families at wait-list early child educations sites. We will collect information through surveys, health measurements, and qualitative interviews and compare results to learn if Water is K'e improves health behaviors, health outcomes, and family cohesion.

Determinants and Outcomes of High vs. Low Ultra-processed Feeding

The goal of this clinical trial is to learn about, test, and compare health outcomes of high vs. low-processed feeding. The main question\[s\] it aims to answer are: • Does consuming a diet rich in unprocessed food improve various health outcomes? Participants will either be instructed to consume a diet rich in unprocessed food for 6 months, or consume their typical diet for 6 months. At various points in the study there will be metabolic health data collected. If there is a comparison group: Researchers will compare the low-processed group to the typical diet group to see if there are improvements in metabolic health.

Wakaya: Rising Up for Choctaw Youth Health

Investigators will conduct a two-group randomized waitlist-control trial to assess the efficacy of the Wakaya: Rising Up for Choctaw Youth Health program on improving physical activity, reducing sedentary behaviors and improving healthful eating habits as well as delaying or reducing alcohol, tobacco and other drug use. Wakaya is an experiential, outdoor, nature-based program grounded in Choctaw values. It is a multi-level intervention that increases individual motivation and leadership skills to make healthy behavioral choices for behavior and exercise.

Comparison of the Bioavailability of the Flavanol of Grape Extracts

Polyphenols are a group of naturally occurring compounds found in cocoa, teas, and grape seed extracts (GSE) that have been linked to various health benefits. This study will provide a greater insight into the relationship between polyphenol consumption and health, and could be used to help with the development of functional food products and novel supplements. Although the advantages of a polyphenol-rich diet are well-established, the bioavailability of GSE (a source of polyphenols) in the context of human digestion and beneficial properties are poorly understood. The investigators will conduct an open-label, randomized, 4-way crossover design with the aim to explore the bioavailability of GSE-derived flavan-3-ols from GSE and their related microbial metabolites and advance understanding of the bioactive properties of flavan-3-ols contributing to the development of more effective dietary strategies and functional food products.

The BEGIN Study Bifidobacterium Infantis to Newborns: Effects of Modulating the Gut Microbial Composition on Growth, Immune Function and Inflammatory Conditions - a Randomized Placebo-controlled Double-blinded Intervention Trial

The goal of The BEGIN Study, a randomized controlled double-blinded intervention trial, is to learn if probiotics, with Bifidobacterium longum subspecies infantis Bifin02 (B. infantis), given to healthy newborns can affect various health outcomes and to explore impacts of the infant gastrointestinal microbiome. The main questions it aims to answer are: * Does B. infantis probiotics impact immune function and does it lower the number of bacterial infections and use of antibiotics? * Does B. infantis probiotics impact overall health, development, growth and wellbeing? * Does B. infantis probiotics impact inflammatory diseases, allergies and autoimmune diseases Researchers will compare B. infantis probiotics to a placebo (a look-alike substance that contains no probiotic) to see if B. infantis colonization impact the human immunesystem and various clinical and biochemical health markers. Participants (parents) will * Orally administrate the B. infantis probiotic to their newborn child daily in three weeks from 7 days of age. * Answer baseline and follow up questionnaires in a study app * Take five stool samples from the child and one stool sample from the mother * Collect a 4 week of passive dust sample at home (Electrostatic Dust fall Collector) * Donate one dried bloodspot and one blood sample from their child

Bioavailability and Bioactivity of Orange Polyphenols

This study will provide a greater insight into the relationship between orange consumption and health (particularly gut health) and could be used to help with the development of novel food products. Oranges are a rich source of (poly)phenols, and although the advantages of a (poly)phenol-rich diet are well-established, the bioavailability and bioactivity of orange (poly)phenols in the context of human digestion are poorly understood. This study will address this gap in research.