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NCT07400367
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is the new clinical term introduced in 2023 to redefine what was formerly known as Non-Alcoholic Fatty Liver Disease (NAFLD). It is defined as fatty liver confirmed by imaging or biopsy, accompanied by at least one cardiometabolic risk factor (e.g., hyperglycemia, dyslipidemia, hypertension, or obesity). Its pathological progression ranges from simple steatosis to steatohepatitis, primarily driven by excessive energy intake, hepatic lipid accumulation, and insulin resistance. MASLD is currently the most prevalent chronic liver disease globally, with a prevalence rate of approximately 30-40%. However, there is no satisfactory pharmacological treatment, leaving lifestyle modification as the primary therapeutic approach. Many patients struggle to effectively adjust their habits, leading to persistent hepatic inflammation and damage, which may eventually progress to end-stage diseases such as cirrhosis and hepatocellular carcinoma. In many developed countries, MASLD has become the leading indication for liver transplantation, imposing a heavy burden on healthcare systems. Gut dysbiosis is closely linked to MASLD. An imbalance in the gut microbiota disrupts the gut-liver axis, leading to impaired intestinal mucosal barrier function. This allows bacterial components to enter the circulation, further triggering hepatic inflammation and abnormal lipid metabolism. Consequently, modulating the gut microbiota is considered a potential therapeutic strategy. Over the past decade, probiotics, prebiotics, and synbiotics have been extensively studied as non-pharmacological treatments for NAFLD. Multiple studies indicate that these products can reduce liver enzymes (AST, ALT), insulin resistance (HOMA-IR), and inflammatory markers (hs-CRP, TNF-α). The most effective combinations typically involve Lactobacillus, Bifidobacterium, and Streptococcus, with a recommended duration of approximately 12 weeks. However, the impact of these products on liver fibrosis, hepatic fat accumulation, and cardiometabolic risk factors remains inconclusive. The probiotic product to be tested consists of Lactobacillus salivarius AP-32, Lactobacillus rhamnosus bv-77, Bifidobacterium animalis CP-9, and Lactobacillus reuteri GL-104. This formulation complies with food safety regulations. In clinical studies, it had been proven as an effective adjuvant method that increased beneficial gut bacteria such as Akkermansia muciniphila and improved the control of blood glucose, lipids, and inflammatory markers. Study Objectives This study aims to investigate the efficacy of this probiotic product as an adjuvant therapy alongside lifestyle modifications in adult patients with MASLD. We will evaluate its impact on: 1. The degree of liver fibrosis and steatosis 2. Cardiometabolic risk factors (BMI, waist circumference, blood lipids, and blood glucose). 3. Inflammatory markers. 4. Gut microbiota composition.
NCT06571994
The goal of this randomized controlled trial is to learn if an intervention of reducing plastic exposure through diet, personal care and cleaning products can improve health outcomes in adult participants with cardiometabolic risk factors. The main questions it aims to answer are: * Will the low plastic exposure intervention reduce urinary excretion of bisphenols? * Will the low plastic exposure intervention reduce urinary excretion of phthalate metabolites? * Can reducing plastic exposure improve cardiometabolic biomarkers? Researchers will compare this 4-week low plastic intervention with a control/no intervention group. Participants in the intervention group will: * be provided with food that have no/low plastic and plastic-associated chemicals * be provided with personal care and cleaning produces that have no/low plastic and plastic-associated chemicals * replace cooking and food preparation equipment with no/low plastic alternatives Participants in the control group will not receive the intervention and are not expected to change their behaviour. All participants will provide biological samples (urine, stool, nasal lavage and blood) at several timepoints during the study and attend 4 clinic visits: screening and before, during and after the intervention. Participants will also complete the sociodemographic questionnaire, a physical activity assessment using the International Physical Activity Questionnaire (IPAQ - Short Form), the 24-hr personal care product recall questionnaire, the plastic-associated chemicals questionnaire and be interviewed by a member of the research team to complete a 24-hour diet recall (24DR-PE) of food consumed, and how it was stored prepared, and consumed. The 24DR-PE will facilitate assessments of deviations from the protocol, and enable the assessment of energy, macro and micronutrient intake.
NCT06775132
This cross-sectional study aims to investigate the associations between dietary intake, cardiometabolic health markers, and gut microbiota composition in Singapore adults.
NCT06953232
In a single-blind, randomised, placebo-controlled crossover manner, this study aims to assess the impact of a high-fat mixed meal containing a whey protein (WP)-enriched milk fat globule membrane (MFGM) powdered ingredient on markers of heart and brain health in the fed state among middle-to-older-aged, postmenopausal women living with overweight and at moderate risk for cardiovascular disease. Participants will attend two \~8 hour study visits, where they will consume a high-fat meal containing a WP-enriched MFGM powdered ingredient or a placebo WP-based powdered ingredient. Each visit will involve anthropometric measurements and periodic assessments of heart health, including blood pressure and blood vessel stiffness measurements, blood sample collections, as well as computer-based tests measuring mood and cognition (brain function) over a 6-hour postprandial period.
NCT06793345
The goal of this clinical trial is to investigate the impact of a 10-week MIWT program on thyroid hormone levels and key cardiometabolic markers in obese postmenopausal women. The main question it aims to answer is: Does MIWT enhance thyroid function and reduce cardiometabolic risk factors in this population? Researchers will compare MIWT (designed to MIWT group) to non-training intervention (designed to control group) to see if the training program works to improve thyroid function and cardiometabolic risk factors. Participants in MIWT group will: perform a 10-week MIWT program, four sessions per week (5 repetitions of 6-min-walking-test (6MWT) at 60-80% of 6MWTdistance measured at baseline, interspersed by 6-min of active recovery between repetitions). Participants in control group will : not perform any physical training and maintain their usual daily activities.
NCT05687240
This study is designed as a two-group parallel randomized controlled trial (N=50) to test effects of 8-weeks of Qigong/Tai Chi (QTC) intervention compared to QTC plus HRVB on HRV parameters (primary), and cardiometabolic risk factors and sequelae (secondary) (e.g., BMI, waist circumference/percent body fat, sleep quality, stress, anxiety/depression, emotional regulation, eating behaviors, and cognitive performance).
NCT05777746
Persons with Type 2 Diabetes (T2D) are at an increased risk of cardiovascular disease (CVD) and mortality. Dietary changes are recommended by guidelines to treat T2D and reduce risk of CVD. Plant-based diets eliminate certain (i.e. vegetarian diet) or eliminate all animal based products (i.e. vegan diet). Clinical trials with plant-based diets have not looked at incidence of CVD as a (primary) outcome, but at intermediate outcomes of cardiovascular risk. A meta-analysis of 8 trials including 369 persons with T2D found an effect of a plant-based diet on glycated hemoglobin (HbA1c) of -0.29% \[95% CI: -0.45, -0.12%\] relative to mostly (omnivorous) low-fat diets or usual diet. The 95%CI ranged from what the authors had defined as clinically trivial to clinically relevant. For lipids, a network meta-analysis in persons with T2D compared the effect of a plant-based diet to a (omnivorous) low fat diet (274 patients allocated to a plant-based diet vs 2047 patients allocated to low fat diets). Compared to omnivorous low fat diets, the mean effect of plant-based diets on LDL-Cholesterol was -0.33 mmol/L \[95%CI:- 0.55, - 0.12\]. However, the quality of the evidence for this estimate was graded as low, mainly due to imprecision and within-study-bias. Furthermore, plant-based diets might reduce blood pressure (BP). However, while vegetarian diets reduce BP in patients with and without hypertension, for vegan diets the effect was only significant in patients with a systolic BP\>130mmHgz (see section 1.4.3). Additionally, the effect of plant-based diets on inflammation, which might also be causally related to CVD risk in persons with T2D, has not been reported in trials with persons with T2D. Furthermore, most clinical trials of plant-based diets in persons with T2D have used resource intensive interventions, like weekly group meetings and cooking sessions. The effect of an online plant-based dietary intervention, which is more scalable, has not been reported in clinical trials. Lastly, factors influencing adherence in these trials have not been reported. In summary, plant-based diets likely lower CVD risk by lowering HbA1c, LDL cholesterol and potentially blood pressure in persons with T2D. However, estimated effect sizes are imprecise and the effect on inflammation is still unknown. Furthermore, trials to date have used resource intensive interventions. Thus, the present trial aims to study the effect of a primarily online plant-based dietary program on (cardio)vascular risk factors in persons with T2D. Additionally, adherence and factors influencing adherence will be investigated. Participants will be randomized to the intervention or control group. The intervention group will be guided to transition to a plant-based dietary pattern using an online platform and online sessions. Researchers will compare the intervention group to the control group, that continues with usual diet, to see if the cardiovascular risk profile of the intervention group improves.
NCT05403294
Obesity is associated with a number of risk factors for cardiovascular disease. Body mass index (BMI) is the most commonly recommended and used anthropometric measure to classify general obesity in clinical and epidemiological studies. It is widely accepted that obesity increases the risk of heart disease and is thought to be a risk factor for adverse outcomes after cardiac surgery. However, recent studies show paradoxical results, wherein obese patients can experience fewer adverse events and lower mortality than patients with normal-low body mass index(BMI) . The discriminative capacity of BMI has been criticized because it cannot distinguish muscle mass from fat mass, or reflect fat distribution . Alternatively, abdominal obesity indices, such as waist circumference (WC) and waist-to-height ratio (WHtR), have been suggested to be better predictor of cardiometabolic abnormalities because they modulate the limitation of BMI. However, they were insufficient in studies.For this reason, scientists turned to find a new anthropometric formula that could better detect obesity-related mortality and morbidity and they developed 2 new methods. Body Shape İndex (ABSI) is calculated using waist circumference, BMI and height parameters. Body Roundness İndex (BRI) is calculated using waist circumference and height parameters. These new indices may reflect visceral adiposity and strongly predict cardiovascular risk, postsurgical outcomes and resource utilisation.
NCT04877548
The aim of the study is to evaluate the effects of an acute intake of two fermented fruits flours as part of a standardized breakfast, in comparison with the acute intake of a standardized breakfast without fermented fruits flour but with the same amount of available carbohydrates, on postprandial glycaemic response and overall metabolism in subjects at cardiometabolic risk. The metabolic parameters will be assessed in fasting and in postprandial period after the consumption of the standardized breakfast.
NCT04021342
A randomized, double blind, counterbalanced, placebo controlled independent groups design to determine the effects of 3 month supplementation with tart cherry concentrate on indices of cardiometabolic health, exercise capacity and cognitive function. Following screening and recruitment, participants are familiarised with the testing equipment and procedures after which they will be randomly assigned to receive either Montmorency tart cherry concentrate (MC) or an isocaloric placebo (PLA), stratified by gender. The study is comprised of two experimental visits and outcome variables are assessed at baseline (before supplementation) and at 3 months (follow up; after supplementation).