Clinical Research Directory

Evaluating Intermittent Fasting In Individuals At High Risk ForPancreatic Cancer Undergoing Screening

To learn whether an eating pattern called intermittent fasting (IF) is tolerable and feasible for individuals at high risk of pancreatic cancer and whether IF is associated with changes in biological markers, including metabolic, inflammatory, microbiome, and imaging-related markers.

Impact of Intermittent Fasting on the Mental Health of Perimenopausal Women

This study will explore how intermittent fasting (specifically the 16/8 method) affects the mental health of women who are in the perimenopause stage. This life stage often brings hormonal changes that can impact emotional and physical well-being. The study will include 98 women aged 45-55, who will be randomly divided into two groups. The study will compare the mental health outcomes of those who follow intermittent fasting with those who do not, using independent t-tests to analyze the results. The goal is to better understand if intermittent fasting can help improve mental health during perimenopause.

Intermittent Fasting for NAFLD in Adults

NAFLD is a growing threat to public health. Currently, there is a significant need for highly effective treatments for NAFLD. Non-obese NAFLD (BMI\<30kg/m2) is an increasingly recognized condition, sometimes described as "lean NAFLD". Intermittent Fasting (IF) may be uniquely beneficial in non-obese NAFLD. The purpose of this study is to identify non-pharmacologic, lifestyle-based methods of NAFLD treatment within non-obese adults.

Effect of Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) on Gastric Emptying

This study aims to assess the effect of using Glucagon-like peptide-1 receptor agonists (GLP-1) receptor agonists on gastric emptying on surgical patients and whether specific guidelines need to be established for these patients. GLP-1 receptor agonists are mainly used for the treatment and mitigation of obesity and metabolic syndromes. One of their mechanisms of action is by delaying gastric emptying, hence increasing satiety. However, patients need to abstain from eating for a set amount of time before surgery to reduce the risk of aspiration. Hence patients who use GLP-1 receptor agonists may need more time to abstain eating (nil-per-os). In this study we aim to assess how much time is sufficient before surgery in these specific population of patients.

Evaluation of the Efficiency of Intermittent Enteral Nutrition on Multi-organ Failure From Patients With Mechanical Ventilation in Intensive Care Unit

This study aims to evaluate the efficiency of intermittent enteral nutrition versus continuous enteral nutrition to prevent from organ failures for patients at the acute phase of sepsis shock with mechanical ventilation in ICU.

The Rufaida Project: Researching the Impact of Ramadan Fasting on the Gut and Vaginal Microbiome

The body's systems are deeply connected, but they are often studied separately. A recent large-scale citizen-science project on women's health, called Isala, discovered a group of gut-related bacteria present in the vaginal microbiome. This finding supports the idea that gut and vaginal bacteria interact closely, a connection known as the gut-vagina axis. However, it remains unclear whether changes in gut bacteria influence the vaginal microbiome. This discovery led to an exploration of how diet affects both the gut and vaginal microbiomes. In the gut, bacteria rely on carbohydrates from food, while in the vagina, bacteria feed on glycogen, a sugar stored in the vaginal lining. This glycogen is broken down into smaller sugars, which beneficial Lactobacillus bacteria use for fermentation. Since starch is a major source of these sugars, researchers suspect that a starch-rich diet may support Lactobacillus growth, which in turn promotes vaginal health. To test this hypothesis, the Rufaida Project was launched. Ramadan is characterised by a fasting period of approximately one month during which participants abstain from eating between sunrise and sunset. Ramadan provides a unique opportunity to study how fasting affects the microbiome under controlled conditions. In this study, 50 Muslim women will be asked to provide vaginal and stool samples at eight predetermined time points-before, during, and after Ramadan. These samples will be analysed using 16S rRNA amplicon sequencing to determine bacterial composition. Comparative analysis will be conducted between samples across different time points and anatomical sites. The objective is to understand how fasting and dietary changes influence the gut and vaginal microbiomes, and whether gut bacteria play a role in shaping vaginal health. Additionally, participants will complete weekly health questionnaires. An additional study group of up to 300 Muslim women will complete weekly questionnaires without providing biological samples. This research could improve understanding of the links between diet, gut health, and vaginal health, potentially leading to new strategies for enhancing women's well-being through nutrition.

Impact of Intermittent Fasting on Sleep and Quality of Life

The goal of this clinical trial is to investigate the impact of intermittent fasting on sleep, quality of life and fatigue among healthy volunteers. The main questions aim to answer: Whether intermittent fasting would allow participants to experience an improvement in their sleep quality, duration and latency? Whether intermittent fasting would ameliorate participants' quality of life and reduce chronic fatigue symptoms? Researchers will compare the two most prevailing fasting windows of intermittent diet including an early morning feeding window (8 a.m.-4 p.m.) and a late feeding window (12 p.m.-8 p.m.) to see if there is a difference among these feeding windows on sleep and quality of life. Participants will: * Be divided into two groups (group A and group B) that will alternate their fasting windows. * Group A will start with intermittent fasting over a feeding period from 12 p.m. to 8 p.m. for one month, then a two weeks period of usual eating habits (washout period) and finally one month of intermittent fasting with a feeding period from 8 a.m. to 4 p.m. * Group B will follow intermittent fasting over a feeding period from 8 a.m. to 4 p.m for one month, then a two weeks period of usual eating habits (washout period) and finally one month of intermittent fasting with a feeding period from 12 p.m. to 8 p.m. * At enrollment, at the end of each month of intermittent fasting and at the end of washout period participants will be asked to complete some questionnaires and will be submitted to anthropometric measurements using impedance scales. * Participants will be asked to complete an electronic 24 hour recall diary using the Automated Self-Administered 24h Dietary Assessment (ASA24) Tool software once per week every week during study.

Longitudinal Monitoring During Intermittent Fasting Protocols in Obese Adults

LIMITFOOD2 is a randomized clinical intervention study that investigates the effects of two different intermittent fasting protocols compared to a control group on the health of obese adults. A total of 90 participants will be randomized into three equally sized groups: a modified alternate day fasting, a time-restricted eating and a control group, receiving general weight-loss counseling.

Intermittent Fasting, Mediterranean Diet and NAFLD

This study aims to evaluate the effects of Intermittent Fasting (IF) 14/10 compared with the Low Glycemic Index Mediterranean Diet on NAFLD.

Intermittent Fasting Versus Carbohydrate Drinks Before Surgery

The purpose of this study is to investigate whether time-restricted feeding, a form of intermittent fasting, before surgery improves insulin resistance around the time of surgery, compared to carbohydrate drinks and standard fasting before surgery.

Intermittent Fasting and Mediterranean Diet in Patient With Multiple Sclerosis

When the literature was reviewed, there is no study in which the effects of intermittent fasting and Mediterranean diet on quality of life, sleep, circadian rhythm and appetite hormones leptin and ghrelin levels in MS patients were evaluated and the two diet types were comparatively examined in terms of all these parameters.

Time-restricted Eating and Cognition

This study aims to investigate how time-restricted eating (TRE), more specifically TRE at different times (early vs late in the day), influences brain activity, behavior, decision-making, food intake, physical activity, the gut microbiome and metabolic processes. The study intervention procedure is a replication of that described in Peters et al. (2021).

Intermittent Fasting to Improve Insulin Secretion

Type 2 diabetes (T2D) mellitus is a challenge for health care systems as the numbers increases constantly. In 2014, 422 million people had been living with diabetes worldwide. The absolute numbers of people with prediabetes have also grown substantially over 25 years worldwide. In Germany, about 10% of the population has T2D and another 21 % of the population has prediabetes.Overall, 16% of all deaths in Germany are attributable to type 2 diabetes. Macro- and microvascular complications of diabetes imply a significant threat for the patients and are already present in the prediabetic state. Short term and long term complications, the burden of treatment, and reduced quality of life are major burdens of the disease. Accumulating data indicate that currently recommended therapeutic diet regimens in patients with obesity and diabetes are not sustainable on the long term. Novel concepts are therefore urgently needed. T2D occurs when insulin secretion from pancreatic beta-cells cannot sufficiently be increased to compensate for insulin resistance. Causes of beta-cell dysfunction are heterogeneous. In addition, the most important determinants of diabetes remission are the extend of weight loss and restoration of beta-cell function. In the course of diabetes progression, the inability to recover insulin secretion might identify the state of no return to normal glucose tolerance. It is therefore crucial to improve insulin secretion in treatment and prevention of diabetes. Up to now lifestyle intervention trials in prediabetes or pharmacological intervention trials in diabetes did not show improvement of insulin secretion after intervention. However, one recent small human trial shows that intermittent fasting (early time restricted fasting) is able to improve insulin secretion.Currently, there are no trials that examine the effect of intermittent fasting in individuals with a broad range of impaired glucose metabolism (from prediabetes to diabetes). Recently novel subtypes of diabetes and prediabetes with high risk for the early manifestation of diabetes complications have been identified. Currently, prevention strategies for this high risk individuals have not been examined yet. We will study for the first time the effectiveness of 4 weeks intermittent fasting on changes in insulin secretion capacity in subphenotypes of diabetes and in prediabetes.

TirolGESUND: Baseline-controlled Comparison of the Effects of Fasting Dietary Intervention or Smoking Cessation Combined With Exercise in Healthy Female Tyrolean Volunteers Aged 30-60 on Epigenetic and Multi-omic Biomarkers of Health, Ageing, and Disease

The goal of this clinical study is to learn about disease-risk and age-associated changes in DNA methylation patterns associated with disease risk or age in healthy women aged 30-60 in response to health-promoting lifestyle intervention (intermittent fasting or smoking cessation). The main questions the study aims to answer are: * Are the scores of DNA methylation in epigenetic signatures associated with age, women's cancer risk, or risk exposure reduced after 6 months of lifestyle intervention compared to baseline? * What are the dynamics of DNA methylation changes during or following intervention, and do differences in changes between different sample types exist? * Which other biomarkers of health and disease, including metabolic changes, microbiome, clinical, mental, or inflammatory parameters, are altered following intervention? The investigators also aim to explore whether DNA methylation changes are associated with changes in other biomarkers mentioned above. Participants will be allocated to intermittent fasting or smoking cessation based on inclusion criteria. Intermittent fasting encompasses a 16:8 intermittent fasting schedule. Food intake is limited to an 8 h window per day with fasting for the remaining 16 h. Within the intermittent fasting study, participants are randomised to receive a ketogenic supplement (medium-chain triglyceride fibre) or not. Participants in the smoking cessation study will be guided to stop smoking. All participants will receive 1:1 personal coaching throughout the study, and will be provided with an optional exercise programme. All participants will also receive nutritional advice from a professional dietician throughout the study. Participants are invited to donate samples every 2 months for 6 months. Researchers will compare signatures at the start and after 6 months of intervention. Within the intermittent fasting group, researchers will compare effects in individuals that received the ketogenic supplement to those that did not.

The Effectiveness of Intermittent Fasting and Behavioral Economics Intervention on Weight Control in Obese Patients

This study is a parallel randomized controlled trial (RCT). To determine the effect of intermittent fasting, intermittent fasting with behavioral economics, and intensive lifestyle modification on nutritional status; the differences between HOMA-IR, body weight change, and body composition in obese people. Each participant will be randomized to receive the intervention (intermittent fasting, intermittent fasting with behavioral economics, or intensive lifestyle modification. The study protocol will be explained to the eligible participant and informed written consent will be obtained. The total sample size will be 123 participants. Blood and urine samples will be collected at baseline and each follow-up visit including 1-month, 2-months, 6-month, and 12-months, respectively for further study to find out the mechanisms of weight loss, weight regain, and the improvement in the metabolic disease.