Loading clinical trials...
Loading clinical trials...
Showing 1-20 of 24 trials
NCT06896175
Introduction: This project studies the impact of Ilex paraguariensis harvest time, commonly known as yerba mate, and its consumption mode (mate, tereré, and mate/terere) on the lipid profile of consumers in the Department of Caaguazú, Paraguay. Yerba mate is rich in bioactive compounds such as polyphenols, xanthines, and saponins. There are no clinical trials conducted in Paraguay with our Ilex paraguariensis plantations that have analyzed the influence of harvest time on the yerba mate production process and the infusion mode, in relation to its effect on dyslipidemias. General Objective: To establish the effectiveness of Ilex paraguariensis harvest time and the mode of consumption of the produced yerba mate on the lipid profile of consumers in the Department of Caaguazú, Paraguay. Methodology: The research approach will be quantitative, using a triple-blind randomized clinical trial design. Participants will be regular consumers of yerba mate, divided into groups based on harvest time (beginning or end of the harvest) and consumption mode (mate, tereré, or both). Lipid profile measurements will be taken at baseline and at 30, 90, and 180 days after consumption. Yerba mate samples will be analyzed and classified according to their bioactive properties before being blinded to the researchers and participants. Expected results: a report on the social, cultural, and anthropometric characterization of regular consumers of mate and tereré, and a report on the concentrations of the bioactive properties of yerba mate; polyphenols, xanthines, saponins from Ilex paraguariensis harvested at the beginning and end of the harvest and the database of patients with baseline lipid profile results, at 30, 90, and 180 days of mate and tereré consumers with yerba mate prepared randomly according to the harvest time of the Ip (beginning or end of harvest) analyzed.
NCT05256654
This a multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy and safety of LY3561774 administered subcutaneously at various doses in participants with mixed dyslipidemia and on a stable dose of a statin.
NCT06860087
Our study aims to explore the influence of dietary chromium supplementation in the form of chromium picolinate, at different doses (200 µg and 400 µg per day), on the health of pregnant women with gestational diabetes. This study will also provide more information on the safety of this type of supplementation during pregnancies complicated by gestational diabetes mellitus. The main questions it aims to answer are: * Does chromium supplementation at various doses in women with gestational diabetes mellitus truly influence their glucido-lipidic metabolism, oxidative/antioxidant balance, and inflammatory state? If so, is it beneficial or detrimental? * If this supplementation is beneficial, which dose is the most appropriate? * Do these types of supplementation have any side effects on the health of the mother and fetus? The participants will take chromium supplements for 6 weeks (supplemented groups) while the control participants will not take them (healthy and diabetic control groups). Chromium-supplemented participants will undergo a medical check-up every 02 weeks to closely monitor their health status and detect any potential side effects at an early stage. Researchers will compare the biochemical profile, oxidative stress status, and inflammation markers between chromium-supplemented and non-supplemented participants to assess the impact of this trace element. Researchers will compare the effects of chromium supplements at different doses with each other.
NCT06381947
Statin intolerance occurs in up to 15-20% of treated patients. The combined use of Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitors with ezetimibe is commonly performed in these patients, and has been associated with an estimated LDL-C reduction of 65-70%. This drug combination may be insufficient to reach the LDL-C target in high- and very-high-risk patients with statin intolerance, also considering the goals recommended by the current international guidelines. Also, PCSK9 inhibitor dosage escalations frequently fail to achieve the target. Doubling the dosage of alirocumab from 75 mg to 150 mg, when administrated as monotherapy, determines a further reduction of only 3,6% of LDL-C serum level. The full dose of Evolocumab (420 mg every two weeks), was approved only in the setting of homozygous familiar hypercholesterolemia. Bempedoic acid is an oral, once-daily prodrug, metabolized in the liver to an active inhibitor of ATP-citrate lyase, blocking cholesterol synthesis upstream of 3-hydroxy-3-methylglutaryl-coenzyme A reductase and thereby increasing hepatic expression of the LDL receptor and decreasing circulating LDL-C levels. The CLEAR (Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen) Harmony trial demonstrated that bempedoic acid in addition to maximally tolerated statin therapy did not lead to a higher incidence of adverse events compared to placebo and significantly lowered LDL-C levels. In the CLEAR Serenity study, bempedoic acid showed a safe and effective profile compared with placebo in patients with statin intolerance. In the CLEAR Tranquility, it provided an oral therapeutic option complementary to ezetimibe in patients intolerant to high-dose statins who required additional LDL-C lowering. The synergistic effect of bempedoic acid plus PCSK9 inhibitors has been investigated by one phase 2 trial (NCT03193047), which showed a statistical superiority of bempedoic acid plus evolocumab strategy versus placebo plus evolocumab in terms of percent change in LDL-C up to 2 months. To date, no randomized phase 3 clinical trial have evaluated the effect of bempedoic acid in association with anti-PCSK9 and ezetimibe in statin-intolerant patients not attaining the recommended LDL-C target. The investigators hypothesized that the association of bempedoic acid with PCSK9 inhibitors and ezetimibe may be safe and effective in reducing LDL-C in statin-intolerant patients.
NCT06060886
SchizOMICS is a Phase IV, multicenter, dose-flexible, open-label, randomized controlled clinical trial to evaluate the efficacy and safety of aripiprazole versus paliperidone using multi-omics data in patients with a first psychotic episode. The trial will include a total of 244 patients, with two arms of treatment with paliperidone and aripiprazole (1:1). The main objectives of the study are: 1. To compare the efficacy and safety of aripiprazole and paliperidone in the treatment of first episode psychosis (FEP) subjects in real-world clinical settings at 3 months. 2. To elucidate whether non-responders after 3 months of adequate treatment may display different molecular signatures at baseline based on multi omics data and systems biology analysis. 3. To uncover whether the appearance of side effects after 1 year of adequate treatment may be related to different molecular signatures based on multi-omics data and lifestyle phenotype using systems biology analysis.
NCT03314714
Accumulation of intramyocellular lipids (IMCLs) due to increased supply of fatty acids can induce defects in the insulin signaling cascade, causing skeletal muscle insulin resistance. However, the causes for muscle insulin resistance are not well understood. The association of elevated IMCLs and insulin resistance has been shown in obese humans and individuals with type 2 diabetes as well as several animal models of insulin resistance. Despite the strong relationship between IMCLs and insulin resistance, this suggested relationship disappears when well-trained endurance athletes are included into this consideration as this group is highly insulin sensitive. This metabolic enigma has been termed the 'athlete's paradox'. The aim of this project is to resolve the mechanisms contributing to the athlete's paradox.
NCT05887180
PräVaNet is a prospective, 1:1 randomized, controlled trial to investigate the efficacy of a new, digitalized prevention strategy ("ePrevention") in cardiovascular high-risk patients with type 2 diabetes mellitus in the outpatient sector.
NCT05135234
When muscles are not contracting, the local energy demand by muscle and use of specific fuels used to produce energy by oxidative metabolism are minimal. The time people spend sitting inactive (sedentary time) typically comprises more than half of the day. This sedentary behavior is associated with elevated risk of diabetes, cardiovascular diseases, some cancers, and multiple conditions leading to poor aging. From a progressive series of experiments, the driving goal is to develop a physiological method for sustaining contractile activity via oxidative metabolism over more time than is possible by traditional exercise (hours, not minutes per day). Developing a physiological method suitable of prolonged muscular activity for ordinary people (who are often unfit) requires gaining fundamental insights about muscle biology and biomechanics. This also entails a careful appreciation of the ability to isolate specific muscles in the leg during controlled movements, such as the soleus muscle during isolated plantarflexion. This includes quantifying specific biological processes that are directly responsive to elevated skeletal muscle recruitment. The investigators will focus on movement that is safe and practical for ordinary people to do given their high amount of daily sitting time. This includes developing methods to optimally raise muscle contractile activity, in a way that is not limited by fatigue, and is feasible throughout as many minutes of the day as possible safely. This also requires development of methodologies to quantify specific muscular activity, rather than generalized body movement. There is a need to learn how much people can increase muscle metabolism by physical activity that is perceived to them as being light effort. It is important to learn if this impacts systemic metabolic processes under experimental conditions over a short term time span in order to avoid confounding influences of changes in body weight or other factors.
NCT04895098
Retrospective observational study of the efficacy and safety of statin monotherapy or statins in combination with ezetimibe in patients receiving lipid-lowering therapy in both primary and secondary prevention of cardiovascular diseases (CVD). The study will include patients receiving lipid-lowering therapy in both primary and secondary prevention of CVD who have received therapy of interest for ≥ 3 months in the 2 years preceding the signing of informed consent, i.e. statins as monotherapy or in combination with ezetimibe in a stable mode (without dose adjustment and/or statin replacement). Effectiveness of therapy will be evaluated based on the data on changes in baseline levels of total cholesterol (CS), low density lipoproteins (LDL), high density lipoproteins (HDL), triglycerides (TG), data on which will be obtained from primary medical records. Demographic and anthropometric data on patients, information on the history of hyperlipidemia and concomitant diseases will also be obtained. Also, the study will collect data on the development of adverse reactions of particular interest during therapy (liver/muscle damage, major cardiovascular events (MACE).
NCT04896619
The study is a randomized, cross-over, double-blind, controlled trial in which participants with mildly elevated levels of cholesterol will receive two 4-week interventions (e.g. kori-tofu or control), with a wash-out period of 4 weeks in between. During the intervention periods, subjects will eat 3 slices of bread per day, representing a Kori-tofu dose of 34.5 grams or a matched reference. Fasting total and LDL cholesterol will be determined at the start and end of each of the two intervention periods.
NCT03310502
Aim of the study is to investigate genes regulating glucose and lipid metabolism in subjects whose glucose metabolism, lipid metabolism, blood flow, or body fat distribution has been measured using positron emission tomography (PET), magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRS) or computed tomography (CT) as part of their previous participation in clinical trials conducted at Turku PET Centre. By combining information from PET, MRI, CT, proteomics, metabolomics and genetics analyses we aim to find connection between genetic variation and metabolic and cardiovascular disease.
NCT04984785
The aim of the study is to evaluate modifications in the metabolism of polyunsaturated fatty acids (PUFA) and biosynthesis of the lipid mediators N-acylethanolamines (NAE), both known to induce and be induced by the nuclear peroxisome proliferator-activated receptor (PPAR)-α, which may also explain the well-established improved lipid and energy metabolism after bariatric surgery. The study is focused on understanding the weight loss mechanisms in order to develop targeted dietary protocols.
NCT01963650
The purpose of this study is evaluate the natural course of disease progression related to gross motor function in children with metachromatic leukodystrophy (MLD).
NCT03898505
Obesity and diabetes are a significant global burden and there is an immediate need for novel treatments and management strategies. Our laboratory determined that avocado derived 17 carbon polyhydroxylated fatty alcohols (PFAs) are inhibitors of fatty acid oxidation (FAO) that impart minimal toxicity in mice. FAO is altered in numerous disease states including obesity and diabetes. In these chronic diseases, excessive FAO in muscle and liver mitochondria cause metabolic overload and inefficiency which drives obesity-associated glucose intolerance and insulin insensitivity. The increased FAO that occurs in obese and diabetic individuals depletes several substrates and intermediates of the Krebs cycle, making them less efficient at using oxidative phosphorylation for energy, which can ultimately lead to glucose insensitivity and weight gain. For these reasons, inhibition of FAO is now an established therapeutic approach for the treatment of type II diabetes as reducing FAO: i) improves cellular metabolism to shift towards the more thermogenic oxidative phosphorylation and glycolysis, and ii) reduces hyperglycemia via inhibiting liver gluconeogenesis while improving glucose homeostasis. In collaboration with an industry partner, Advanced Orthomolecular Research (AOR; Calgary, AB), the investigators have developed a supplement containing a blend of 17-carbon PFAs found inside a commercially available food grade avocado powder. The primary objective of this clinical trial is to determine if the avocado derived supplement is safe for oral consumption compared to a placebo-controlled group.
NCT03313869
This experiment consists on a 20-day reduction in daily step in free-living active individuals to induce physical inactivity. This will be used to test the efficacy of the anti-oxidant cocktail we aim to test as a new countermeasure in 2016 during the 60-d bed rest planed by ESA/CNES. The objective of this study is to investigate whether the cocktail of natural antioxidants XXS-2A comprising vitamin E and coupled with omega-3 helps to prevent and / or reduce the glucose intolerance and improve oxidative defenses induced by 20 days of physical inactivity through daily step reduction Although physical inactivity is reported to affect glucose tolerance within days of inactivity, we selected a period of 20 days for the effect of the cocktail to take place and assess secondary molecular mechanisms. The effect of this short period of inactivity on metabolism will moreover be boosted during the last 10 days by taking fructose, a sugar found in abundance in fruits, honey and juices, which is known to quickly trigger metabolic deregulation.
NCT02329067
The objectives of the proposed study are to assess whether the metabolic effects of walnut consumption depends on which food components the walnuts substitute (i.e. carbohydrates; saturated fatty acids) and whether it is important to consume walnuts as snacks or with meals.
NCT03173495
Cardiovascular Diseases (CVDs) are the leading causes of death in the world and in Brazil. In 2001, 12.45 million deaths on the globe (21% of the total) were caused by some CVD. The composition of modern man's diet has changed drastically with the industrialization of food, resulting in the transition from a diet rich in fibers and complex carbohydrates to one with a high content of sugars and fats. Since the current dietary pattern is characterized by the consumption of three or more meals a day, containing a quantity of fat in the range of 20 to 70 g, individuals spend a large part of the day in the postprandial state, with continuous fluctuation of lipemia Over 18 hours. Food intake (postprandial state) is the dynamic, unstable response of the body that refers to rapid hormonal and lipoprotein remodeling. It is well established in the literature that high-fat meals (lipid overload) cause an increase in plasma triglycerides. Hypertriglyceridemia and / or elevated triglyceride-rich lipoproteins (LRT) (chylomicrons, VLDL and their remnants) in the postprandial state induces endothelial dysfunction via increased oxidative stress and is an independent risk factor for CVDs. Therefore, Postprandial Lipemia (PPL) is counted as an early marker of atherosclerotic process, metabolic abnormalities and endothelial dysfunction. High-carbohydrate (CHO) diets may promote increased LDL-c, TG, VLDL and HDL-c reduction, as well as PPL, generating a lipid profile associated with an increased risk of CVDs. This effect appears to be more pronounced with the inclusion of simple carbohydrates (mono and disaccharides), although it also occurs with diets rich in complex carbohydrates (polysaccharides). High fructose diets (HFDs) are a known model of induction of insulin resistance, dyslipidemia and DM2 in primates and humans. The chronic effect of fructose consumption has been well studied in the last decades due to its connection with obesity, resistance to Insulin, accumulation of visceral fat and dyslipidemia. As the consumption of fructose is progressively increasing in society and its chronic exposure can generate a phenotypic effect of dyslipidemia and, consequently, the increased risk of CVDs, prevention and treatment strategies should be seen as an important public health issue . Thus, the objective of this study is to understand the effects of exercise on fat metabolism, since there is a lack of robust evidence about the possible cardioprotective and hypolipemic role of the same on HFD.
NCT03082794
Negative-calorie diet is among the popular dieting guides for weight loss; however, there is still little knowledge about this method. The present study aimed to determine the effects of negative-calorie diet on weight loss and lipid profile, and to compare its efficiency with low-calorie diet in men.
NCT02689765
Metabolic problems represent one of the major health concerns which are attractive for being addressed by nutritional interventions, as these are directly connected to dietary habits.Anthocyans possess cardiovascular disease prevention, obesity control, and diabetes alleviation properties, but association between anthocyans and prediabetes need to be more firmly understood and established from robust clinical data. However, there is little human research that has reported on the efficacy of increased anthocyans bioactive consumption on insulin sensitivity in pre-diabetes.
NCT01668836
Women have a natural protection that gives them greater longevity. One hypothesis most commonly used is the estrogen protection in the premenopausal period. However many studies of various forms of hormone replacement therapy proved ineffective in promoting additional protection for women. Thus, it is discussed other ways of protection associated with longevity in women. Of these, the sirtuin system was found in several animal studies to be associated with longevity. This system also showed, through the involvement of several metabolic pathways, an important protection against the process of atherosclerosis. But the activity of this system in humans is unknown and if it is more active in women than in men. The study's main objectives are to analyze this system in healthy 24 women and 24 men aged 55 to 65 years, and their influence on the main metabolic pathways related to longevity and the process of atherosclerosis. The research protocol includes analysis of the influence of sirtuin (SIRT1) in vascular reactivity, lipid profile, antioxidant capacity, markers of inflammation and homeostasis, before and after the interventions with caloric restriction or resveratrol administration. It is expected of this study mechanistic conclusion for longevity and possible clinical applications in the mechanism of atherosclerosis prevention.