Clinical trials

The goal of this clinical trial is to study how whole-body electrical stimulation combined with amino acid intake affects muscle health in ventilated ICU patients. The main questions to answer are: * Does electrostimulation improve the balance of muscle protein in ICU patients? * Does combining electrostimulation with amino acid help build muscle and prevent muscle loss? Researchers will compare three groups of patients: 1. Sham electrostimulation (no current applied) + the standard nutrition 2. Electrostimulation + the standard nutrition 3. Electrostimulation + a 20g amino acid bolus Participants will: * Receive either real or sham electrostimulation * Get their standard nutrition or a 20g amino acid bolus * Have marked amino acids given through an IV * Have blood samples taken to measure the amino acids and glucose in the blood * Undergo ultrasound of the upper arm to measure the blood flow

The aim of the present study is to assess the impact of short-term forearm immobilization on forearm muscle glucose uptake and amino acid net balance and kinetics in individuals with T2D compared with a control group with normoglycaemia.

This study evaluates the effects of a Combined Lifestyle Intervention Program (CLIP) on sleep, lifestyle behaviors, obesity risk and health in night-shift workers. The primary objective is to assess the effect of the CLIP on objectively measured sleep duration. Secondary objectives include behavioral outcomes related to sleep, diet, physical activity, and stress, as well as body weight and metabolic outcomes, . It is hypothesized that CLIP participants will show a greater increase in sleep duration than controls, alongside favorable changes in lifestyle and health outcomes.

People tend to regulate intake by the weight of food rather than its energy content, making energy dense foods, especially those combining salty, fatty, and umami tastes, more likely to promote passive overconsumption. Lowering energy density can reduce daily energy intake, but often decreases palatability, whereas umami can enhance palatability, and sometimes decrease food intake. This suggests that adding umami to a regular energy dense diet could reduce food intake over time, and that adding umami to a reduced energy dense diet could sustain palatability and limit compensatory energy intake. Therefore, the aim of this study is to assess the effect of a 2-week dietary intervention of adding umami and/or lowering energy density on food intake. Secondary objectives are whether adding umami and/or lowering energy density affect dietary satisfaction, appetite, perceived umami intensity, food preferences, bodyweight and composition, and wellbeing ratings. This will assessed in a double-blind crossover, randomized controlled trial of three times two weeks, each separated by two weeks washout in 33 healthy Dutch adults between 18-65 years of age, with a BMI between 20-30. Umami taste will be added through MSG supplementation of the three main meals. Supplementation will depend on both intervention group, and individual participants' body weight. Energy density will be lowered by swapping regular products for low-fat, low-sugar or higher water products. The three intervention diets will vary in umami taste intensity, and/or energy density: 1) regular energy density without added umami (control), 2) regular energy density with added umami, 3) reduced energy density with added umami. Umami will be supplemented by supplementing food items with 55-60 mg MSG per kg bodyweight daily, divided over three eating occasions. Foods will be offered ad libitum, and participants will add a seasoning sachet containing MSG to their selected portion. The primary objective will be to compare average daily food intake (kcal) over two weeks between the three dietary interventions differing in umami taste intensity and energy density. Secondary outcomes are dietary satisfaction, appetite, perceived umami intensity, food preferences, bodyweight and composition, and wellbeing ratings.

The aim is to develop a food supplement drink that supports muscle health by combining specific fatty acids, which can positively affect metabolic and inflammation processes that are important for muscle health.

Background of the study: Enhanced immune responses can lead to chronic hyperinflammation, which contributes to the development of non-communicable diseases such as type 2 diabetes and cardiovascular disease. Poor dietary habits, particularly the consumption of high-fat meals, are thought to trigger this process by increasing the concentration of triglyceride-rich lipoproteins in the bloodstream, resulting in postprandial triglyceridemia. This state stimulates immune cell activation, elevates circulating lipopolysaccharide levels, and enhances the production of inflammatory mediators including IL-6, TNFα, VCAM1, and ICAM1, as well as changes in inflammatory gene expression in peripheral blood mononuclear cells. Until now, most research investigating the relationship between fat intake and postprandial inflammation has focused on the effects of a single high-fat meal. However, in daily life, individuals typically spend the majority of the day-up to 18 hours-in a postprandial state, continuously exposed to multiple meals containing a mix of macronutrients and fats from diverse sources. It remains unclear how repeated fat intake influences the timing, magnitude, and overall pattern of the postprandial immune response. The MIRACLE study is designed to address this gap by exploring how repetitive postprandial fat exposure affects circulating immune cells in healthy individuals, comparing the effects of plant-derived and dairy-derived lipids. The study employs a double-blind, randomized, cross-over, two-armed intervention design in which each participant acts as their own control. Objective of the study: The primary objective of the MIRACLE study is to determine how daily repetitive exposure to lipids from the same source modulates the postprandial immune response, as reflected by IL-6 levels, compared with acute exposure. Postprandial IL-6 concentrations will be measured using multiplex ELISA assays at multiple time points following the high-fat shake at baseline (T0) and after repeated exposure (T1). These data will allow calculation of protein dynamics and incremental area under the curve (iAUC) values for IL-6. Secondary objectives: Secondary objectives include comparing postprandial IL-6 iAUC values across T0, T1, and T2; comparing IL-6 responses between the plant- and dairy-derived fats; and identifying mechanisms underlying lipid-induced immunomodulation in PBMCs, including changes in immune cell functioning, phenotypes, and circulating inflammatory parameters. The study will also assess the effects of repeated fat intake on postprandial metabolic markers such as glucose and triglyceride levels. Glucose will be continuously monitored using glucose sensors, while other metabolic parameters will be measured in plasma. Additionally, the relationship between body composition, as assessed by Dual Energy X-ray Absorptiometry (DXA), and postprandial immune and metabolic responses will be evaluated at T0, T1, and T2. Study design: On each test day, a catheter cannula will be inserted into an antecubital vein, followed by a 30-minute rest period before measurements begin. Baseline blood samples (t = 0) will be drawn from the catheter, after which participants consume a 0.6 L high-fat shake containing 95 grams of fat from one of the two lipid sources. Subsequent blood samples will be collected at 0.5, 1, 2, 3, 4, and 6 hours post-consumption to monitor postprandial responses. Following the first test day, participants will consume smaller breakfast shakes (\~300 mL, \~20 grams of fat) daily for four consecutive weeks, using lipid powders corresponding to the same fat source. After these four weeks, the postprandial test day will be repeated following the same procedures as on the first day. After the second test day, a washout period of two weeks will take place before participants return for a third test day, again following the same protocol. This will be followed by another washout period of two weeks to three months before beginning the second arm of the study, during which participants will consume lipids from the alternate fat source. Thus, each participant completes both the plant-derived and dairy-derived fat interventions in a randomized order, ensuring within-subject comparison. Study population: 39 healthy male or female volunteers, age 40-70, BMI 22-27. Intervention: 2 different breakfast shakes based on either plant-derived or dairy-derived fat.

The aim of the study is to investigate the effect of non-nutritive sweeteners on glucose regulation. Secondary objectives are to investigate the effect of NNS on gut microbiome, gut hormone secretion, sweet taste sensitivity and preference, and the excretion of NNS in urine.

The aim of this randomized controlled trial is to investigate the feasibility of increasing preoperative dietary fiber intake in individuals with colorectal cancer who will undergo surgery. This will be done using 1) digital personalized dietary advice or 2) a dried vegetable product compared to 3) habitual diet (control).

The goal of this clinical trial is to examine the effect of whole-body electrostimulation with protein intake on muscle protein synthesis, muscle mass and function during bed rest in healthy young adults (18-35 years). The main questions to answer are: * Does whole-body NMES followed by protein intake improve muscle protein synthesis rates during 3 days of bed rest? * Does repeated NMES sessions offer protective effects on muscle mass and function during extended periods of inactivity? Researchers will compare sham electrical electrostimulation, electrical stimulation and electrical stimulation + protein groups to see if whole-body electrostimulation combined with protein intake offers the greatest improvement in muscle protein metabolism and muscle preservation. Participants will: * Undergo 3 days of bed rest while receiving one of the following interventions: * Sham-NMES followed by standard nutrition (CON) * Whole-body NMES followed by standard nutrition(NMES) * Whole-body NMES followed by a bolus of 20g protein (NMES+PRO) * Receive heavy water (D2O) to assess body water turnover. * Undergo leg extension exercises to assess muscle function. * Have quadriceps muscle thickness measured via ultrasound. * Provide saliva samples for analysis. * Have calf circumference measured to monitor changes in muscle mass.

Hip fractures often lead to functional limitations, loss of independence, weight loss and decreased well-being. Only half of the patients regain their functional level and 24% die within the following year. Financial consequences are significant due to costly surgery and long-term care. Hip fracture incidence is expected to increase sharply due to the ageing population, reducing accessibility to and quality of rehabilitation care. Therefore, optimizing treatment is essential. Previous protein and exercise studies showed improved muscle and bone health in healthy or frail community-dwelling older adults, but effects in older hip fracture patients are not known. Better rehabilitation may improve bone and muscle health, nutritional status, quality of life, lower costs and lower burden for healthcare. The overall objective is to investigate the effectiveness, costs and cost-effectiveness of a protein-enriched diet and resistance exercise for 3 months compared to usual care on bone and muscle health, and quality of life in older adults recovering from an acute hip fracture.

Rationale: Protein from plant-based foods may be unable to stimulate protein synthesis due to a suboptimal essential amino acid content and a lower digestibility. However, a more optimal amino acid profile may be achieved by increasing portions sizes and blending multiple plant-based sources. Studies investigating the anabolic properties of vegan diets (total elimination of animal-based foods) rather than single plant-based foods in older adults are scarce. It remains unknown if a vegan diet can also affect protein synthesis rates in other musculoskeletal tissues than muscle. Primary objective: To assess the effects of a 2-week preoperative vegan diet in comparison to an omnivorous diet on protein synthesis rates in Hoffa's fat pad, synovium, tendon, bone, ligaments, menisci, and cartilage in older adults with knee osteoarthritis undergoing total knee arthroplasty. Secondary objective: To assess the effects of a 2-week preoperative vegan diet in comparison to an omnivorous diet on blood pressure and plasma amino acids in older adults with knee osteoarthritis undergoing total knee arthroplasty. Study design: Multi-center, randomized, controlled trial with an intervention and a control group. Study population: 40 older adults (60 - 80 years) with osteoarthritis of the knee undergoing total knee replacement. Intervention: Controlled vegan diet versus controlled omnivorous diet, for a duration of 14 days. Main study parameters/endpoints: Primary study parameters are protein synthesis rates of Hoffa's fat pad, synovium, tendon, bone, ligament, menisci, and cartilage. Secondary parameters include blood pressure and plasma amino acids.

A randomized, placebo-controlled, parallel, double-blind trial with three intervention arms and a period of four intervention-weeks that assesses the intake of different dosages of a complex fiber product on bowel function via microbiota changes in subjects that are unsatisfied with their current bowel function.

The GEOLynch cohort study has been established to investigate the influence of genetic, environmental and other factors on tumour risk in persons with Lynch syndrome.