Treatment Trials

13 Clinical Trials for Various Conditions

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COMPLETED
Dietary Analysis for Caries Prevention in Children Using a Computer Software
Description

Children will be recruited from the pediatric dentistry clinic of Marquette University at their first or recall appointment and will be asked to fill a questionnaire regarding their dietary habits. Afterwards a dietary analysis will be performed using a computer software, developed for this study and dietary instructions will be given to the children.

Conditions
NOT_YET_RECRUITING
Collagen Protein Versus Placebo on Muscle Recovery
Description

This study is focused on exploring the gap in the literature by comparing the effects of collagen protein versus placebo supplementation on the musculotendinous unit following muscle damaging protocol. Thus, the purpose of this study is to identify and compare the effect of collagen protein versus placebo supplementation on indirect markers of musculotendinous unit recovery following eccentric calf exercises.

UNKNOWN
Select Nutrient and Gene Variant Analysis in a Targeted Diet and Lifestyle Intervention Reduces Preterm Birth
Description

Preterm birth (PTB) rates in the US are among the highest in wealthy nations across the globe, and they are particularly high in our most socio-economically disadvantaged populations. PTB increases lifelong morbidity and mortality at significant economic cost. In addition to neonates born too early, small for gestational infants predict the greatest risk for chronic disease in the neonate (F1 generation) through adulthood. Single lifestyle, nutrient, or medical interventions intended to reduce PTB have produced mixed results, but combined micronutrient interventions appear more successful. The investigators experienced a reduced preterm birth rate and combined preeclampsia, gestational diabetes and small for gestational age rate in a 50% Medicaid population by providing targeted micro/macronutrient, genomic and lifestyle evaluation with personalized intervention in a trimester-by-trimester group educational setting (1). The model requires validation in more diverse populations. This study will be applied in a 100% Medicaid population with greater ethnic diversity. Participation will be voluntary, offered to all pregnant participants enrolling at 18 weeks gestation or earlier with the comparator group being those participants who decline the intervention. The study population will receive targeted biomarker evaluation including serum 25-OH D, zinc and carnitine levels, dried blood spot omega 3 fatty acids and select gene variant analysis. Virtual group nutrition and lifestyle education visits conducted by the nutritionist cluster participants in the same trimester allowing for personalization of the nutrition and lifestyle plan based on the data collected and adapted to the specific needs of the trimester. Each study participant will receive individualized nutrient supplementation and probiotic supplementation. Anticipated performance improvement endpoints are significant reduction of preterm birth and combined incidence of preeclampsia, gestational diabetes, small for gestational age, neonatal morbidities and related health care expenses. The investigators will explore gene variants' role in directing nutrition, lifestyle and toxic exposure interventions and in predicting adverse maternal and neonatal outcomes.

RECRUITING
Impact of Dietary Intervention on Inflammation and Microbiome Composition Post-Colonoscopy
Description

This study aims to investigate the impact of various healthy diets, specifically a modified plant-based Mediterranean diet, on the gut microbiome and overall well-being post-colonoscopy. The investigators hypothesize that certain diets can positively influence gut bacteria, reducing inflammation and enhancing metabolic signals. To explore this, they will utilize metagenomic testing on stool samples to analyze the DNA of gut microorganisms. Additionally, they will conduct immune profiling on serum samples and perform metabolomic analysis to comprehensively evaluate the diet-induced changes in immune response and metabolic pathways. This multi-faceted approach will help them understand how dietary changes affect the composition and function of the gut microbiome, immune function, and overall metabolism.

RECRUITING
Biomarker Cost-Benefit Analysis of EFNEP
Description

The goal of this integrated project is to assess whether EFNEP is a cost-effective nutrition education intervention that generates sustained improvement in chronic disease biomarkers. This project will be unique in its use of objective biomarkers, instead of self-reported behaviors, to quantify the economic benefits generated by EFNEP through chronic disease prevention. A paired location untreated control group quasi-experimental design will be employed, with biomarkers (BMI, blood pressure, HbA1c) measured for 500 adults across four representative state EFNEP programs (CO, FL, MD, WA). Biomarkers will be measured pre-EFNEP, 6-months-post-EFNEP and 1-year-post-EFNEP. Analytical techniques will include cost-benefit, bivariate, and multivariate analyses.

Conditions
ACTIVE_NOT_RECRUITING
Analysis of MicroBial Metabolites After Eating Refined Food
Description

The purpose of this study is to learn more about what happens in the human body after consuming a meal that contains ultra-processed foods like hamburgers, and if this is different to what happens after consuming a meal that contains lots of whole foods, like fresh vegetables, instead.

Conditions
COMPLETED
Meta-analysis of Soluble Fiber Consumption on Body Weight, Glycemia, and Insulinemia in Overweight and Obese Adults.
Description

Dietary fiber intake is protective against overweight and obesity; however, a significant fiber gap exists between consumption and recommended intake values. Soluble fiber beneficially impacts metabolism, and supplementation may be a feasible approach to improve body composition and glycemia in overweight and obese individuals. The investigators will evaluate results of randomized controlled trials (RCTs) of soluble fiber supplementation among overweight and obese adults for outcomes related to weight management (e.g. body mass index \[BMI\], body weight, body fat percentage, waist circumference) and glucose and insulin homeostasis (e.g. fasting glucose, homeostasis model assessment of insulin resistance \[HOMA-IR\], fasting insulin) through systematic review and meta-analysis.

Conditions
COMPLETED
Evaluating the Relationship Between Physical Activity, Diet, Weight, and the Neighborhood Environment for Adolescents
Description

Many teenagers have unhealthy eating habits and do not get enough physical activity. This study will examine whether the neighborhood in which a teenager lives affects his/her quality of life, physical activity levels, and eating habits.

Conditions
COMPLETED
Diet and Behavior in Young Children With Autism
Description

This study will determine whether a gluten- and casein-free diet has specific benefits for children with autism.

COMPLETED
Evaluating the Effects of an Oral Protein Supplement on Children's Growth Patterns
Description

This single-center, randomized controlled pilot study aims to evaluate the efficacy of TruHeight Growth Protein Shake on improving growth patterns in children aged 4-17 years. Over six months, participants will consume the protein shake daily, five times a week, with outcomes measured in terms of type X collagen concentration in urine, height via a stadiometer, and body composition using an INBODY device.

COMPLETED
Resistant Starch Blend Gastrointestinal Impact
Description

This study aims to test the hypothesis that a unique blend of resistant starches and fiber will promote gastrointestinal health, as measured by an increase in short-chain fatty acids and improvement in quality of life measures in conjunction with microbial community changes. This study specifically evaluates the impact on short-chain fatty acids and gut microbiota and the impact on quality of life from a resistant starch blend in healthy adult humans with occasional gastrointestinal distress.

COMPLETED
Weight Management Demonstration Project: HEALTH
Description

The study investigated the effectiveness and cost-effectiveness of a cognitive and behavioral weight management program, complemented by an interactive Web site and brief telephone coaching, implemented among TRICARE non-active-duty beneficiaries. A total of 1,755 participants from four Midwestern states were randomized to one of three randomized controlled trial groups with increasing intervention intensity: mailed material and basic Web access (RCT1), plus an interactive Web site (RCT2), plus brief phone- and Web-based coaching support from health lifestyle coaches (RCT3). The study assessed changes in participants' weight, blood pressure, diet, and physical activity from baseline to 6, 12, and 15 to 18 months. Analyses estimated overall cost savings and calculated the cost-effectiveness ratio of each randomized controlled trial compared with a "do-nothing" alternative as the cost per quality-adjusted life year.

Conditions
COMPLETED
Nuclear Morphology of Breast Cells in Ductal Lavage
Description

Breast nipple aspirate fluids (NAF) are useful for non-invasive monitoring of the breast. NAF has been shown to exhibit large inter-individual differences in lipid peroxidation. Unfortunately, the yield of epithelial cells in NAF is low. More recently, breast ductal lavage has been approved for clinical use. Nuclear morphologic features of breast biopsies have been shown previously to have prognostic value for breast cancer risk. In women without cancer, there may be subtle changes in the breast epithelial cells that can only be defined with computer-assisted measurements. The subjects selected for this study will be 98 women with biopsy-confirmed proliferative breast disease. These women are at slightly increased breast cancer risk, and exhibit higher mean levels of cholesterol and cholesterol oxides in NAF than women with non-proliferative histology in the breast. Levels of 8-isoprostane, cholesterol, fatty acids, fat-soluble micronutrients and 2,6-cyclolycopene-4,5-diol will be quantified in breast NAF that is obtained before breast lavage. These measures were chosen based on their potential relationship to dietary intakes and to oxidative stress, which is relevant to the application of these methods to dietary prevention studies.The investigators will characterize the morphology of breast epithelial cells from lavage using quantitative image cytometry to capture nuclear and cellular area, diameter, roundness, perimeter, and nuclear:cytoplasmic area ratio. Correlations will be evaluated between the measured morphologic features and each analyte in the NAF. The impact of various clinical, demographic and dietary factors on cellular morphology will also be explored. This study will help establish the feasibility of using these measures as endpoints in dietary intervention studies and will generate hypotheses that should be tested in larger studies. Such measures also should be applicable to molecular epidemiological investigations that seek to examine the impact of certain gene polymorphisms and environmental exposures on biomarkers of cancer risk.