Clinical Research Directory

Testing the Feasibility and Impact of a Whole-Food Plant-Based Diet Intervention on College Students

The goal of this pilot randomized controlled trial (RCT) was to assess the feasibility, acceptability, and impacts of a whole-food plant-based (WFPB) vegan diet intervention for undergraduate university students randomly assigned, stratifying by sex and race/ethnicity, to one of two intervention groups (each with a distinct teaching-learning design, i.e., interactive (IA) versus lecture-based (LB)) and a control group. The main questions the researchers aimed to answer were: * Were the study procedures feasible and acceptable for the overall sample and were the intervention sessions, following a WFPB vegan diet, and the prospect of continuing this diet feasible and acceptable for the intervention participants? * Were there greater improvements in diet quality, WFPB vegan diet adherence, physical and mental health, and intrapersonal factor outcomes for the intervention group engaging in interactive learning compared to the intervention group learning through traditional lecture? And were there greater improvements in these outcomes for both intervention groups compared with the control group? The researchers compared the group outcome means for the two intervention groups against one another and those for the two intervention groups against those of the control group. Study participants completed two sets of measurements over the course of 6 weeks. * All participants completed online baseline and post-intervention surveys and in-person baseline and post-intervention biometric measurements. * Only the intervention group participants attended three 75-minute consecutive weekly intervention sessions to learn about different aspects of the WFPB vegan diet between the two sets of survey and biometric measurements.

Acute Metabolic Response Versus Long-term Adaptation to a Vegan Diet

At baseline, venous blood samples were collected from all eligible participants. The following biochemical parameters were analysed: serum electrolytes (mineral profile), fasting glucose, creatinine, urea nitrogen, total proteins, albumin, bilirubin, liver enzymes, C-reactive protein (CRP), total cholesterol, triacylglycerols (TAG), serum iron, active vitamin D, vitamin B12, complete blood count. At baseline, all participants also underwent standardized anthropometric measurements, including height (cm), body weight (kg) and BMI was calculated accordingly. Body composition was assessed using bioelectrical impedance analysis with the InBody Tanita MC-780MA device. The following parameters were recorded: total body fat (kg, %), visceral fat (kg, %), skeletal muscle mass (kg, %), total muscle mass (kg, %), total body water (kg, %), sarcopenic index (kg/m²), phase angle. To assess health-related quality of life and symptom burden, all participants completed validated questionnaires: World Health Organization Quality of Life - Brief Version (WHOQOL-BREF), Patient Assessment of Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM), Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10), Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QoL) and Patient Health Questionnaire-15 (PHQ-15). After the one-month intervention, participants in the VEG group repeated laboratory testing, anthropometric assessment, body composition analysis, and questionnaire evaluation. The same follow-up assessments were performed in the WD group for comparative purposes. Long-term vegans (VEG-P) did not undergo repeated measurements. Dietary Monitoring and Adherence At study enrolment, all participants were offered a dietary consultation to improve adherence to the assigned dietary regimen. Participants were also instructed to maintain a food diary throughout the study period, which was periodically reviewed via telephone or email consultation.

Vegan Diet in Small Children

Following increased knowledge about climate change and how food production affects greenhouse gas emissions, the interest in vegetarian diets is increasing. In line with this, also vegan diet is becoming more common at all ages, including in young children. But the state of knowledge regarding the effect of this diet on children during infancy and early childhood has been poorly studied and existing literature consists to a large extent of case reports. With the main hypothesis that vegan diet from the introduction of complementary foods causes reduced bio availability of certain micronutrients important for development, the aim of this study is to examine dietary intake and development during the first years of life in a group of children eating vegan diet and compare with a reference group eating mixed diets. In an observational study, investigators plan to include 30 children before the age of 6 months during the years 2021-2026, where the parents have decided to offer their child only vegan food. The children are studied in comparison with a reference group of 30 matched cases regarding growth, nutritional status, and dietary intake. Data collection includes monthly dietary records and blood sample analyses and growth at 6, 12 and 24 months. At the age of 3, cognitive developmental assessment (WPSSI-IV) and an DEXA examination of body composition are performed. The study is expected to contribute to increased knowledge about the risk and benefits of vegan diets and thereby provide a better basis for future recommendations.

The Treatment of Painful Diabetic Neuropathy With Diet

The purpose of this clinical trial is to determine whether targeted nutritional changes can improve symptoms of painful diabetic neuropathy. Impaired blood flow to peripheral nerves-resulting in reduced oxygen delivery and subsequent nerve injury-is a well-established contributor to neuropathy. Prior studies have shown that a whole-food, plant-based diet without added oils can improve or even reverse arterial disease, suggesting a potential mechanism for enhancing nerve perfusion and function. This study is a randomized controlled trial comparing a whole-food, plant-based diet with standard pharmacologic management for painful diabetic neuropathy.

Vegan Diet and Immune-Inflammatory Outcomes in Asthma and Healthy Adults

This randomized controlled study evaluates the effects of a balanced vegan diet compared with a balanced omnivorous diet on inflammatory and immune response markers and clinical asthma parameters in healthy adults and individuals with mild to moderate asthma, aged 18 to 50. Participants will follow assigned dietary plans for 12 weeks with dietitian support delivered via digital tools.

Analysis of NfL and GFAP in Different Dietary Patterns

This observational study aims to investigate the impact of different dietary patterns on brain tissue biomarkers in healthy young adults by measuring blood levels of NfL and GFAP. The primary research question is: Do vegan, vegetarian, or omnivorous diets influence NfL and GFAP levels?

Effect of Vegan Diet on Microbiome and Metabolism

The goal of this interventional study is to investigate how vegan diet affects health in healthy volunteers, Men and women ages 20 - 30 years old. The main questions it aims to answer are: Change in Microbial community composition and metabolic alterations Changes in plasma metabolic profile. Researchers will compare changes in microbiota and plasma metabolites profile to see the influence of vegan diet in health. In the dietary trial, participants were first assigned to a 2-week omnivorous diet phase, then switched to a 2-week vegetarian diet phase

Influencing a Vegan Diet and the Intake of Dietary Supplements During Pregnancy and Childhood

The main goals of the exploratory, cross-sectional survey among vegans are to reveal influencing factors, sources of information gathering, reasons for choosing certain dietary supplements of pregnant vegans and parents, difficulties in administering dietary supplements to children, and the compliance of dietary supplements of vegans, because there is no data available yet. Results serve as a starting point for comprehensive information provision for surveyed vegans and provide insight into the nutritional knowledge of vegans. The advisory role of the medical experts is essential to provide vegans with reliable information on a balanced vegan diet and dietary supplements. The opinion of medical experts has a decisive influence on the health of vegans. For this reason the content of their advice will be assessed. The main questions the study aims to answer are: Do vegan pregnant women and parents know about possible nutrient deficiencies during pregnancy and childhood and who do they turn to for information about nutritional supplements? What is the quality of the information received?