Clinical Research Directory

Impact of Training Load on the Gut miCrobiome And Its Relation to exeRcise Performance, mUscle Phenotype, and markerS of Overreaching in Healthy Men

The goal of this study is to learn how different amounts of supervised indoor cycling training change gut health (gut bacteria, the substances gut bacteria make, and the gut barrier integrity), and how these changes relate to changes in fitness, muscle health, and signs of doing too much training (a state called 'overreaching'). The study includes healthy, recreationally active men aged 18 to 45 years. The primary questions, for which the study is powered (sufficient participants included), are: 1. Does moderate load training change blood and faecal levels of butyrate (a short-chain fatty acid made by gut bacteria) after eight weeks compared with a control group? 2. Compared to moderate load training, do higher training loads lead to different responses in blood and faecal levels of butyrate? Researchers will compare: * A control group that does not complete structured training; * A moderate-load training group that completes eight weeks of supervised cycling (4x/week); * A high-load training group that completes four weeks of moderate-load training followed by four weeks of higher training load (twice the number of training sessions). Participants will: * Be randomly assigned to one of the three groups; * Complete 8 weeks of supervised indoor cycling sessions if assigned to a training group; * Complete four study assessment periods (baseline, after week four, after week eight, and after a short taper (rest period); * Provide blood, stool, skeletal muscle, urine, saliva, and breath samples during the assessment periods; * Complete fitness and performance tests and questionnaires during the assessment periods.

Sodium-rich COndiments Unifying Health and Taste

This research aims to develop an evidence-based classification for sodium-rich condiments (natremic index) based on their CVD-related risks. It is hypothesised that the acute cardiovascular and physiological response (effectively extrapolated to long-term CVD risks) to meals prepared with various sodium-rich condiments can be leveraged upon for the development of such an index that will systematically classify sodium-rich condiments based on the risk they present to cardiovascular health.

Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity

The study will assign participants to take either the medication, empagliflozin or a placebo for 12 weeks. The goal of the study is to determine the effects of empagliflozin on arterial health in Veterans with obesity.

The Influence of Sleep on Cardiovascular Outcomes

The goal of this study is to identify the effects of sleep regularity on cardiovascular regulatory mechanisms. The investigators are hoping to discover if improving the regularity of sleep timing will improve metabolic and vascular health markers. The protocol is a 12-week prospective cohort study that includes both field and in-laboratory data collection in ostensibly healthy male and female adults, aged 18-40years. We will also have a sub-group of individuals with chronic pain to examine the effects of sleep regularity on pain outcomes.

Double-task Exercise in Older Adults at Risk of Cognitive Decline (MeMo-Health-Cog-3 Program)

Cerebral small vessel disease is a frequent cause of cognitive disability among older adults (OAs) in Mexico that imposes a significant burden on the health system and OAs' families. We have called the program Mind and Movement for Cognitive Health (MeMo-Salud-Cog-3). Programs to prevent or delay OAs' cognitive decline are scarce. Methods and analysis: A double-blind, randomized clinical trial will be conducted. The study will aim to evaluate two 24-week double-task (aerobic and cognitive) square-stepping exercise programs for OAs at risk of cognitive decline-one program with and another without caregiver participation-and to compare these with an aerobic-balance-stretching exercise program (control group). 255 OAs (85 per group) affiliated with the Mexican Institute of Social Security (IMSS) between 60 and 65 years of age with self-reported cognitive concerns will participate. They will be stratified by education level and randomly allocated to the groups. The intervention will last 24 weeks, and the effect of each program will be evaluated 12, 24, and 52 weeks after the intervention. Participants' demographic and clinical characteristics will be collected at baseline. The outcomes will include: (i) general cognitive function; (ii) specific cognitive functions; (iii) dual-task gait; (iv) blood pressure; (v) carotid intima-media thickness; (vi) carotid arterial compliance; (vii) OAs' health-related quality of life; and (viii) caregiver burden. We will estimate differences in outcomes between each intervention group and the control group at baseline and follow-up evaluations. We will assess differences-in-differences (D-in-D) treatment effects using a D-in-D estimator. If we identify statistically significant differences in participants' baseline characteristics between the groups, we will adjust the D-in-D estimators by these covariates using generalized linear regression models. Ethics and dissemination: The study was approved by the IMSS Ethics and Research Committee (registration number 2018-785-095). All participants will sign a consent form prior to their participation. The study results will be disseminated to IMSS authorities, healthcare providers and the research community.

Heterogeneity of Vascular Adaptations to Exercise With Aging in Women and Men

The goal of the proposed study is to understand the reasons for the variability in aerobic exercise (AE) training benefits on the vasculature in middle-age and older (MA/O) adults, including differences between men and women. To achieve this goal, a mechanistic randomized controlled (RCT) will be conducted, in which adults are randomized to 12-weeks intervention of AE or no-exercise Control. Our overall hypothesis is that the exercise response variation in vascular benefits is related to age and sex differences in the biological changes underlying vascular aging and/or the molecular transducers (i.e., circulating molecules) that communicate and coordinate the effects of AE on the vasculature in the periphery and brain. Because this is a mechanistic trial, the overall goal is not a single health-related outcome. Rather, the goal is to advance our understanding of the molecular signals and pathways underlying the systemic and local effects of AE on vascular health that may explain the variability in AE responses with age and sex. This knowledge will allow for the development of personalized age- and sex-specific AE recommendations, and/or provide insights into molecular targets that can be manipulated to enhance and/or mimic exercise in non-responders or in persons unable to exercise.

the Effects of Different Exercise on Vascular Health

To explore the effect of smart app and wearable-based lifestyle intervention management on vascular health, comparing different exercise with the improvement of vascular arterial stiffness. The accuracy and consistency evaluation of smart wearable devices in screening for vascular health risks were also discussed.