Multi-Organ Denervation With the iRF System to RedUce Sympathetic Drive
HypertensionType 2 Diabetes1 moreThe objective of the study is to evaluate the safety of multi-organ denervation using the Integrated Radio Frequency (iRF) Denervation System. and to understand any potential improvement in hypertension and glycemic control.
Effects of Adding L-BAIBA or L-BAIBA + Grains of Paradise to Exercising Adult Overweight and Obese...
ObeseWeight Loss2 moreThe goal of this intervention study is to examine changes in body composition, weight loss, and cardio-metabolic risk factors after adding supplementation of L-Beta aminoisobutyric acid (L-BAIBA) and Grains of Paradise to exercise in overweight and obese men and women. Participants will supplement for 8 weeks and complete a 8 week exercise protocol.
A Clinical Study to Evaluate the Safety and Tolerability of BioPB-01 in Healthy Adults
Metabolic SyndromeThe present study is a randomized, placebo-controlled, parallel-group, double-blind clinical study. Seventy-eight individuals will be screened, and considering a screening failure rate of 20%, approximately 64 participants will be randomized in a ratio of 1:1 to receive either BioPB-01 or Placebo
Prebiotics in Patients With Non-alcoholic Liver Disease
Non-alcoholic Fatty Liver DiseaseMetabolic SyndromeThe purpose of this present study is to evaluating whether prebiotics - ITF (Inulin/OFS 75/25) is effective in treating patients with non-alcoholic liver disease.
Developing a Positive Psychology Intervention to Promote Health Behaviors in Metabolic Syndrome:...
Metabolic SyndromeSpecific Aim #1 (Feasibility; primary aim): To assess the feasibility of the PP-MI group-based physical activity intervention and outcome assessments in patients with MetS. Hypothesis: The PP exercises and MI-based goal-setting sessions will be feasible: most (≥50%) of participants will complete 6/9 exercises/sessions. Furthermore, the investigators will be able to obtain objective physical activity measurement follow-up data from at least 80% of enrolled participants at the end of the intervention and 24 weeks later. Specific Aim #2 (Acceptability): To assess whether the intervention is acceptable to participants, as measured by ratings provided after each PP-MI session. Hypothesis: The intervention will be acceptable: participants will rate the PP-MI exercises with a mean score of at least 7 out of 10 on ease of completion and helpfulness. Specific Aim #3 (Outcomes): To assess whether this preliminary intervention appears to result in improvement of physical activity, related health behaviors (sedentary time, diet quality), psychological well-being (optimism, positive affect, anxiety, depression), and the exploratory outcomes of MetS-relevant physiological markers (e.g., blood pressure, weight, chart-reviewed lipids and HbA1C). Hypothesis a: The intervention will lead to improvements in physical activity, related health behaviors, optimism and positive affect, reductions in depression and anxiety at 9 weeks and 24 weeks compared to baseline (or the start of the intervention, for the WLC group). Hypothesis b: The hypothesis is that there will be improvements in the exploratory outcomes of the physiological markers, even if they do not reach significance.
Grape Polyphenols and Metabolic Syndrome
Metabolic SyndromeProtection AgainstFruits and vegetables are beneficial for patients with metabolic syndrome, a condition characterized by the coexistence of various risk factors (obesity, hypertension, hypercholesterolemia, insulin resistance) that predispose to cardiovascular disease and diabetes. Diets such as the Mediterranean diet, rich in flavonoids and polyphenolic compounds can exert a high anti-inflammatory, antithrombotic and antiproliferative action. Several studies have shown that grape polyphenols exert a crucial protective action against the onset of cardiovascular, neurodegenerative, and cancer diseases. On the other hand, little information is available on the health effects deriving from the consumption of table grapes on cell membranes lipidomic profile. On this basis, the aim of this study is the evaluation of possible changes in lipidomic profile and plasma antioxidant activity induced by a diet enriched with table grape polyphenols.
Effect of Pasteurized Akkermansia Muciniphila on Insulin Resistance in Otherwise Healthy Subjects...
Metabolic SyndromePre-diabetes1 moreThe purpose of this study is to demonstrate the efficacy of pasteurized Akkermansia muciniphila (pAKK) in improving insulin sensitivity in hyperglycaemic, but otherwise healthy persons with metabolic syndrome. This is the primary objective of this study. Secondary objectives consist of evaluation of the effects of next generation beneficial microbes on metabolic health, anthropometry and body composition, and safety. Therefore, the trial is designed as a phase 2, randomized, double-blind, placebo-controlled, parallel group, multi-center trial comparing pAKK with placebo in restoring insulin sensitivity in dysglycaemic but otherwise healthy subjects with metabolic syndrome. In total, 144 enrolled participants will attend 6 study visits in total. Study visits may be conducted in the clinic, at home by a Healthcare Professional, or by telephone / telemedicine.
Standard Duodenal Switch vs. Single Anastomosis Duodeno-Ileostomy Duodenal Switch
ObesitySurgery2 moreThe aim of the Torsby I Trial is to identify differences and similarities between a standard duodenal switch (DS) and a single-anastomosis duodeno-ileostomy (SADI) regarding effect on weight, comorbidities and malnutrition.
PREMIER: PREvention of Metabolic Illness Through prEcision nutRition
ObesityType 2 Diabetes4 moreDietary intake is a major driving force behind the escalating obesity and type 2 diabetes epidemics. Large, high-quality clinical trials have shown that close adherence to healthy dietary recommendations significantly reduce the incidence of obesity and type 2 diabetes, especially among people at increased risk. However, large inter-individual variability exists in response to dietary interventions. To inform more effective obesity and type 2 diabetes prevention strategies, it is crucial to better understand the biological, environmental, and social factors that influence how people interact and respond to specific foods. In a recent large-scale genome-wide association study, our research team has identified 96 genomic regions associated with overall variation in dietary intake. This study provided evidence that inherited molecular differences are likely to impact on food intake (i.e., preference for certain foods) and metabolic homeostasis (i.e., glucose regulation). Connecting knowledge about human genetic variants with information from circulating metabolites can be particularly useful in understanding the mechanisms by which some people experience a detrimental response to specific foods. The specific objective of the PREMIER study is to carry out an interventional dietary study to measure the response of blood glucose and other biomarkers to a standardized meal, and evaluate the extent to which food choices differ among individuals with distinct genetic susceptibility.
Effect of Interrupting Sedentary Time With Different Frequencies of Physical Activity on Cardiometabolic...
SedentaryCardiometabolic Syndrome1 moreThe knowledge gap on sedentary behavior and sedentary breaks includes whether detrimental effects of sedentary behavior can be fully attenuated by 1.) sedentary breaks 2.) physical activity or 3.) both combined. Specifically, when breaking sedentary time which physical activity pattern- and intensity modifies the negative effects of sedentary behavior on glucose- and lipid metabolism? This lack of quantitative evidence calls for prospective experimental studies investigating the physiological and biological impacts of sedentary behavior, as well as the effectiveness of different strategies to reduce sedentary time. Thus, quantifying effects of the intensity, frequency, volume and investigating the patterns of sedentary breaks and/or physical activity on predefined outcomes is of importance. Aims: Our primary aims are to investigate the effects of breaking up sedentary time on glucose- and lipid metabolism and thus examine whether pattern for sedentary bouts and breaks and physical activity intensity during sedentary breaks matter. Specifically, the aims of the PhD-project are to provide knowledge on the following questions: • How does different patterns of accumulation of sedentary bouts and breaks acutely influence glucose- and lipid metabolism under iso-caloric conditions?