Clinical Research Directory

Dietary Behavior Intervention in African Americans at Risk for Cardiovascular Disease

Background: The risk of heart disease among African Americans is still common despite a greater understanding of the disease and better approaches to managing it. Healthy cooking and eating patterns can help reduce the risk of heart disease. But things like access to grocery stores and knowledge of good nutrition can affect these healthy patterns. Researchers want to see if community-based programs can help. Objective: To learn about the cooking behaviors of African American adults at risk for heart disease. Also, to see if a community-based cooking intervention will affect home-cooking behaviors. Eligibility: African American adults 18 and older who live in Wards 7 and 8 of Washington, D.C., and have at least one self-reported risk factor for heart disease Design: Phase I participants will complete a survey. It asks about their medical history, lifestyle, stress level, and eating habits. They will take part in a focus group. During this, they will talk about what they eat and what foods are available to them. Participation lasts 1 day for 3 hours at Pennsylvania Avenue Baptist Church in Washington, D.C. Phase II participants will go to shared cooking events at Pennsylvania Avenue Baptist Church. These will be held once a week for 6 weeks. They will be led by a trained chef. Participants will visit the NIH Clinical Center 3 times. Transportation will be provided if they need it. They will have physical exams and have blood drawn. They will be interviewed and complete questionnaires. A dietician will review the food they eat. An occupational therapist will assess their cooking skills. They will keep a daily cooking journal. Participation lasts 18 weeks.

Identification of Objective Metabolomics-based Biomarkers of Yogurt Consumption

Substantial evidence links yogurt consumption to a lower risk of type 2 diabetes (T2D). However, the existing evidence is derived exclusively from prospective cohort studies relying on self-reported dietary questionnaires, which-despite being validated-are subject to random and systematic errors that may compromise evidence quality and hinder regulatory approval. The project aims to discover and validate biomarkers of yogurt intake. The investigators will conduct a randomized, crossover, dose-response feeding trial involving 16 generally healthy adult participants (8 females, 8 males). The trial will include four 7-day diet periods, each separated by a 1-week washout. All diets will be based on a dairy-free background and supplemented with one of the following: (a) 1 serving of soy-based pudding (no yogurt), (b) 0.5 serving of yogurt, (c) 1 serving of yogurt, or (d) 2 servings of yogurt per 2,380 kcal/day. On the 7th day of each diet, participants will complete a mixed-meal test at INAF, consuming a smoothie containing the same yogurt dose as during the preceding days. Plasma samples collected in the postprandial state will be used to profile over 20,000 metabolites. Using artificial intelligence-based approaches, potential biomarkers of yogurt intake will be identified. These candidates will then be filtered using standard statistical methods to assess dose- and time-responsiveness, robustness, and biological plausibility. Biomarkers that meet all criteria will be considered validated indicators of yogurt intake.

Wild Blueberries for Gut, Brain, and Heart Health in Adults With High Blood Pressure

The purpose of the study is to determine the effectiveness of wild blueberries on cardiovascular health, cognitive function, and gut microbiota composition in non-Hispanic Black and White adults with elevated blood pressure.

Using Tailored mHealth Strategies to Promote Weight Management Among Adolescent and Young Adult Cancer Survivors

The AYA WELL study is a 2-arm randomized clinical trial to test the efficacy of a theory-based, mHealth weight management intervention adapted specifically for adolescent and young adult cancer survivors compared to a self-guided arm. Participants, diagnosed with cancer between ages 15-39, currently age 18-39, post-treatment at least 6 months, and who have overweight or obesity will be randomized to receive either: 1) a comprehensive mHealth weight management program (intervention) or 2) digital tools + health education + peer support (self-guided) over 12 months. Outcomes will be assessed at 3, 6, and 12 months.

Assessing Dietary Intake of Selected Food Components Using Short Questionnaires

The aim of the study is to validate short questionnaires for assessing dietary intake of selected food components, with a focus on dietary fibre and iron. Two internationally developed short questionnaires (FiberScreen \[for dietary fibre\] and IRONQ-FFQ \[for iron\]) were adapted to the Slovenian context and will be compared with the standard 24-hour dietary recall method.

Biomarker-estimated Flavanol Intake in Davis (FID)

Flavanols are compounds present in plants, including apples, berries, peaches, cocoa-derived products and certain beverages like tea. Following intake, they are absorbed and broken down into smaller compounds called 'metabolites'. Some of these metabolites are excreted in urine. In this study, we hope to collect urine and examine the metabolites to learn more about the types and amounts of flavanols that people are consuming as part of their usual diet.

MIND Foods and Aerobic Training in Black Adults With HTN

The goal of this randomized controlled trial is to determine the impact of Mediterranean-Dash Intervention for Neurodegenerative Delay (MIND) diet and aerobic training on cognition in Black adults with high systolic blood pressure. Researchers will compare Food Delivery and Cooking PLUS Aerobic Training (FoRKS+) versus Enhanced Usual Care (EUC) to evaluate the effects on cognition. Participants will complete cognitive and cardiovascular assessments, 24-hr blood pressure monitoring, standard blood pressure measurements, weight, fingerstick for HbA1c point-of-care testing, and questionnaires. Participants may also choose to participate in an optional blood draw for DNA Repair Capacity testing as a modifiable risk factor for aging-associated diseases.

The prEgnanCy and eArly Childhood nutrItion triaL (ECAIL)

The purpose of this study is to conduct a randomized controlled trial among 800 socially disadvantaged pregnant women and their families to test the effectiveness of a multi-component home visitation nutrition program, compared to usual care, in promoting healthy feeding practices, lifestyle behaviors and growth in young children.

Protein Supplementation During Dialysis (PROSED)

When a patient has dialysis some nutrients are lost in the process. Nutritional losses include protein, trace elements (i.e. zinc, copper and selenium) and water-soluble vitamins (Vitamins C and B). These nutrients are essential for normal body function, including a good immune system and nutritional status. For example, on average the protein losses during a dialysis session (the process where the blood is cleaned via a machine and special fluid) is equal to 6g of protein/day (which is the equivalent of the amount of protein in 1 egg). Protein needs for the general population are 0.8g protein per kg of body weight. Because people on dialysis lose protein via the dialysis, it is thought that these people need to eat more protein. Currently, in clinical practice for people receiving dialysis, the guidelines are to aim for 1.1 -1.4g of protein per kg of body weight. However, the research is old and very weak. Dialysis treatments have changed over the past 40 years, and the investigator does not know if the replacement of these nutritional losses is important to how well people do on dialysis and if they have any effect on survival. Previous research is mostly limited to haemodialysis (a type of dialysis that requires a machine which cleans the patients' blood via special filters) and peritoneal dialysis (this is a type of dialysis which happens via the patients' tummy). There is no research on the nutritional supplementation in home HD and nocturnal HD. Our research will investigate if a higher protein provision leads to a reduction is hospital admissions and improved outcomes in patients receiving dialysis.

Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents

Generation Victoria (GenV) is a longitudinal, population-based study of Victorian children and their parents that will bring together data on a wide range of conditions ,exposures and outcomes. GenV blends study-collected, study-enhanced and linked data. It will be multi-purpose, supporting observational, interventional, health services and policy research within the same cohort. It is designed to address physical, mental and social issues experienced during childhood, as well as the antecedents of a wide range of diseases of ageing. It seeks to generate translatable evidence (prediction, prevention, treatments, services) to improve future wellbeing and reduce the future disease burden of children and adults. The GenV Cohort 2020s is open to all children born over a two-year period, and their parents, residing in the state of Victoria Australia. The GenV Cohort 2020s is preceded by an Advance Cohort of children born between 5 Dec 2020 and 3 October 2021, and their parents. This comprises all families recruited at GenV's Vanguard hospital (Joan Kirner Women's and Children's) and at birthing hospitals throughout Victoria as GenV scaled up to commence recruiting for the GenV Cohort 2020s. The Advance Cohort have ongoing and full participation in GenV for their lifetime unless they withdraw but may have less complete data and biosamples.

The Effect of Pectin Supplementation on Geriatric With Frailty: A Randomised Placebo-Controlled Dietary Intervention Study

The study involves the intake of Low-methoxy (LM) pectin (polysaccharides extracted from citrus peels), which are commonly found in the UK diet (not pharmacological agents), to test their effects on systematic inflammation in the body and gut microbiome composition. Study subjects will be healthy elderly with early signs of frailty or pre-frailty from the local population and will be asked to attend the laboratory on 2 occasions; before and after 4-week' supplementing the diet daily with either 10g of pectin with 10g of whey protein and 10g of cocoa powder added as flavour (active arm) or 10g of whey protein with 10g of cocoa powder added as flavour (placebo). Participants will be given the blinded products portioned in individual sachets, with instructions to add the contents of one sachet a day to 150ml of milk and to consume immediately. At each study visit (\~90 minutes), participants will be asked to provide a stool and blood sample, will have blood pressure, heart rate, weight, height, and waist/hip ratio measured, research team will perform physical functioning test (Time up and go test, 30-second sit to stand test) as well as participants will complete the quality-of-life questionnaire (SF-36), the Depression and Anxiety (HADS) and the Gastrointestinal Symptom Rating Scale (GSRS).

Norwegian Microbiota Study in Anorexia Nervosa

Anorexia nervosa (AN) is a serious mental disorder occurring mainly in women. AN is characterized by severely restricted food-intake and subsequent low weight. The disease burden for the individual is high with medical complications and psychiatric comorbidities. Despite decades of research, there are large gaps in the understanding of the biological aspects of AN and lack of effective interventions. Current clinical treatment is associated with gastrointestinal problems, high rates of relapse and poor outcome causing long-term sickness absence and disability. During the COVID19 pandemic the prevalence and severity of AN has spiked. Therefore, there is great need of novel strategies for AN treatment, that can be easily implemented in the clinic without adding complexity to the standard care of treatment. During the resent years it has been proposed that mental disorders might be treated via manipulating the composition and function of the microbes that live in the gut (the microbiota) by adding or restricting fermentable nutrients (prebiotics) in the diet. However, in order to use prebiotics to treat the microbiota in AN patients, more knowledge is needed on how the AN microbiota is affected by the current standard care treatment. Whether prebiotics can be useful for normalizing AN microbiota remains to be established. The overall aim of the "Norwegian study of Microbiota in Anorexia Nervosa" (NORMA) is to join forces of researchers, clinical health care services and voluntary sector in a transdiciplinary approach to improve the understanding of the role of the gut microbiota in AN patients. The current project will include a clinical trial in AN patients and experimental studies to screen novel prebiotics for their ability to modify and normalize AN derived microbiota. The long-term goal of the project is to pave the way for a targeted and clinically feasible individualized treatment for better tolerable weight-restoration and improved health in AN patients.

Increasing Affordable Fruits and Vegetables for Families With Food Insecurity

Investigator will test an intervention to increase use of a fruit and vegetable incentive program in South Carolina for families in the Supplemental Nutrition Assistance Program (SNAP) experiencing food insecurity. Caregivers are randomized to an intervention or an education-only, wait-list control group. The investigators hypothesize the intervention will improve diet-related outcomes, above and beyond the education-only wait-list control.

Challenges in Achieving Adequate Dietary Status of Women

The aim of the study is to investigate the dietary habits of women of reproductive age (20-49 years). We aim to obtain epidemiological data on the intake and adequacy of key macronutrients and micronutrients, as well as to explore associations with various health indicators. Additionally, we will focus on the nutritional status of subgroups with specific dietary practices, such as vegetarians and vegans.

TREC@TAMU Cancer Prevention Registry and Repository

This study collects health and genetic information to implement cancer prevention and treatment strategies.

Healthy Plant-based Diet and Periodontal Treatment

Background: Periodontitis is a highly prevalent chronic disease, affecting around 743 million people globally. In Hong Kong, over 90% of adults have bleeding gums, and 50% of the elderly have severe periodontitis. The causes of periodontitis are complex, involving polymicrobial dysbiosis, chronic inflammation, immune response, and environmental factors. Current treatments focus on oral hygiene, biofilm/calculus removal, and surgery for advanced cases. While lifestyle and risk factor modifications can improve treatment outcomes, only a few modifiable factors, like smoking cessation and diabetes control, have been established. Identifying more modifiable risk factors and implementing effective interventions are crucial to address this significant public health issue. Diet has shown to be a major modifiable risk factors in pathophysiology of diabetes mellitus and cardiovascular diseases. The recent Global Burden of Diseases (GBD) study also supports this by pointing out the key dietary risk factors for chronic diseases and mortality. Nonetheless, the role of dietary intervention in the field of periodontitis is poorly understood. The evidence of a plant-based dietary pattern, defined by a higher consumption of plant foods and lower intake of animal foods, on preventing and treating NCDs is emerging and a "healthy plant-based dietary pattern" is shown to lower risk of periodontitis and elevated serum antibody levels against periodontopathogens. "Healthful plant-based dietary pattern" mainly comprises of high consumption of healthy plant food (e.g., whole grains, fruit and vegetable), but low proportion intake of unhealthy plant food (e.g., refined grains, fruit juices, and sugar-sweetened beverages) . Although the cross-sectional data from National Health and Nutrition Examination Survey (NHANES) shows promising benefits of the healthful plant-based diet, it is still inconclusive whether "healthful plant-based dietary pattern" is beneficial in preventing and treating periodontal disease. Therefore, it is planned to carry out a high quality, randomised controlled trial to support advocating this dietary pattern in periodontal patients. Hypothesis: It is hypothesized that non-surgical periodontal treatment (NSPT) performed in conjunction with healthful plant-based diet would provide additional clinical, immunological and microbiological benefits without incurring malnutrition periodontitis patients Materials and Methods: 1. Recruitment of subjects 1. Patients diagnosed with Stage II and Stage III Periodontitis will be recruited from the Reception and Primary Care Clinic of the Prince Philip Dental Hospital and the Institute for Advanced Dentistry, The University of Hong Kong. 2. Participants enrolled will be randomized into two groups, one test group and one control group (with or without dietary intervention on healthy plant-based diet) 2. Study Procedures 1. Baseline examination At baseline, besides the routine periodontal examination, patients will undergo dietary assessment by performing the Food Frequency Questionnaire (FFQ), anthropometric measures, oral health related quality of life and physical activity assessment . Biological samples for instance the blood, saliva, fecal and subgingival plaque will also be collected. 2. Periodontal treatment Step I and Step II periodontal therapy including, oral hygiene instructions, control of risk factors, extraction of hopeless teeth, if any, scaling and root surface debridement will be provided to both groups 3. Dietary intervention The participants in the test group will participate in a 3-month active intervention phase, a 3-month reinforcement phase, and a 6-month maintenance phase, with the intervention delivered by a trained and registered dietitian. The participants in the control group will continue the ad libitum diets based on their current eating habits and receive no dietary interventions.. 4. Recall Schedule The follow-up visits will be conducted at 2 weeks, 4 weeks, 3, 6 and 12 months after completion of the debridement. Significance: This study will provide local data and explore whether healthful plant-based diet as an adjunct to non-surgical periodontal treatment can improve clinical outcome, and provide scientific evidence of its effect on clinical, immunological and microbiological markers of periodontitis. This can help us understand more on the relationship of healthful plant-based diet and periodontal diseases, which may eventually provide new perspectives for treatment of patients with periodontitis.

Methylation Diet and Lifestyle Study

The maintenance of health and the progression of disease are associated with an individual's genetic make-up and environmental factors, including lifestyle choices (such as diet, exercise, behaviors, stressors, sleep, tobacco and alcohol use), environmental exposures and socioeconomic determinants. Environmental factors have been shown to influence, sometimes rapidly, epigenetic processes thereby influencing genetic expression. Regulation of the human genome by the epigenome is now regarded as a cornerstone, heritable, physiologic process, playing a key role in phenotypic expression of health and disease. DNA methylation is a well-researched, primary epigenetic process. Aberrant DNA methylation resulting in hyper- or hypomethylated regions of the genome, generally results in inhibition or expression of certain genes and has been associated with the pathogenesis of numerous conditions, ranging from inflammation and accelerated aging, to cancer, autoimmunity, diabetes, heart disease, dementia, allergic disease, posttraumatic stress disease and others. Likewise, certain healthy diet and lifestyle habits have been demonstrated to favorably influence DNA methylation patterns. Understanding that environmental factors can potently and sometimes rapidly, favorably or negatively influence epigenetic expression, a short-term diet and lifestyle intervention may significantly augment DNA methylation expression. The purpose of this study is to evaluate a 9-week diet and lifestyle intervention on patient-reported quality of life, symptoms, and DNA and biochemical methylation-related biomarkers in healthy males ages 50-72.

Fasting Mimicking Diet and Autophagy

This study aims to evaluates autophagy in circulating white blood cells from generally healthy human volunteers exposed to fasting mimicking diet (FMD), a 5-day dietary regimen.

Dietary Counseling Coupled With FMT in the Treatment of Obesity and NAFLD - the DIFTOB Study

There are several studies performed to reveal the linkage between diet, fecal microbiota, and obesity. Human fecal microbiota transplantations in this asset are still scarce. Therefore, this pilot study of FMT from lean to obese people with dietary counseling will increase the knowledge, whether FMT could play a role in the treatment of obesity and NAFLD. Our primary outcome is the changes in glucose metabolism by HOMA-IR.