Clinical Research Directory

BRE-13: Mediterranean Diet

Explore the effect of MedDiet vs. Usual Diet on circulating and breast tumor fatty acid profiles. The investigators aim to examine impact on tumor biology in newly diagnosed participants.

Advancing Health Equity and Preventive Cardiovascular Care in Indigenous and Remote Communities: a Mobile Healthcare Unit

Indigenous people living in Canada face significant healthcare inequities, particularly in basic, primary, and secondary prevention, leading to higher rates of cardiovascular disease and mortality. This program aims to develop a comprehensive understanding of the contextual and individual determinants influencing Indigenous health, and to address health disparities by using tailored community-led participatory research and care initiatives. The investigator and research team use a Mobile Healthcare Unit travelling to Indigenous communities, providing customized, impactful, and sustainable preventive care that adapts dynamically to the evolving needs of each community. The initiative places a strong emphasis on equity and inclusivity, aiming to generate original data in Indigenous and remote underrepresented/underserved populations. This proposal will improve opportunities of identifying facilitators and barriers to preventive care in Indigenous and remote communities. This focus is vital for reducing health disparities and aligns with the Truth and Reconciliation Calls to Action. To maximize knowledge mobilization and ensure culturally appropriate initiatives align with community needs and priorities, this research program collaborates with the Indigenous University Hub at Laval University, local community members and leaders, and Indigenous peoples with lived experience. Existing national and international collaborations with Indigenous communities further enhance the initiative's potential impact and foster knowledge mobilization on a global scale. The ultimate goal is to empower Indigenous peoples and communities to advocate for systemic changes to fight inequities in healthcare in accordance with appropriated truth and reconciliation efforts.

SUSTAINA Study: Effects of Sustainable Diet and Therapeutic Exercise on Health in Young Athletes

The SUSTAINA study aims to evaluate the effects of sustainable dietary programs combined with individualized therapeutic exercise on metabolic health, body composition, and musculoskeletal function in young athletes. Participants will be randomly assigned to different intervention groups receiving tailored exercise training and nutritional guidance based on Mediterranean diet principles. The study will assess physiological, anthropometric, and functional outcomes to identify effective strategies for preventing metabolic and musculoskeletal disorders.

Effects of the Buchinger Wilhelmi Fasting Program and Exercise on Physical Fitness and Sleep Quality

Type of Study: Clinical Trial Goal: The goal of this clinical trial is to investigate whether combining the Buchinger Wilhelmi prolonged fasting program with a structured exercise program can improve physical fitness, body composition, cardiometabolic health, sleep quality, and health-related quality of life. The study will also investigate metabolic responses to prolonged fasting and whether these responses are influenced by exercise. Participant Population/Health Conditions: The study will involve adults attending the Buchinger Wilhelmi Clinic who undergo the prolonged fasting program and meet the study eligibility criteria. Main Questions: * Does structured exercise performed before and/or during prolonged fasting enhance its effects on physical fitness, body composition, and cardiometabolic health? * Does structured exercise improve sleep quality and health-related quality of life during prolonged fasting? Participants Will: * Undergo the Buchinger Wilhelmi prolonged fasting program. * Choose whether to complete an online exercise program before the clinical stay and/or a supervised exercise program during fasting. * Undergo physiological, physical fitness, and body composition assessments before and after the intervention. * Provide blood samples to assess cardiometabolic and metabolic responses. * Complete assessments of sleep and health-related quality of life. Comparison Groups: Researchers will compare the four study conditions to determine whether structured exercise performed before and/or during prolonged fasting enhances the physiological, metabolic, and functional effects of the Buchinger Wilhelmi fasting program.

Validation of a Novel Incremental Step Test for Assessment of Cardiopulmonary Fitness and Ventilatory Thresholds in Adults

The purpose of this single-group diagnostic validation and test-retest reliability study is to determine whether a novel Incremental Step Test (IST) can accurately assess cardiorespiratory fitness and ventilatory thresholds in healthy adults compared with an established laboratory-based cycle ergometer Cardiopulmonary Exercise Test (CPET). The main questions are whether the step test can elicit reliable physiological responses sufficient to identify the anaerobic threshold and respiratory compensation point, and whether it produces reproducible results when repeated under standardised conditions. The study will compare the incremental step test (IST) with CPET to assess whether the IST provides similar peak and submaximal physiological measures and agreement with CPET comparator. Participants will complete three laboratory exercise tests across separate visits: one maximal CPET on a cycle ergometer, followed by two repeated ISTs performed on a 25 cm step board following the audio metronome.

The Austrian LEAD (Lung hEart sociAl boDy) Study

The LEAD study is the first longitudinal cohort investigating respiratory, cardiac, and metabolic health in a reference population of Austria.

The Effects of Quercefit® and Ubiqsome™ in Mitigating Inflammation and Promoting Metabolic Health

The goal of this clinical trial is to learn if Quercefit® or Ubiqsome™ can improve markers of healthy aging, blood sugar control, and heart health in older adults. It will also learn about the safety of these supplements. The main questions it aims to answer are: 1. Do Quercefit® or Ubiqsome™ improve blood sugar, cholesterol, and markers of aging compared to a placebo? 2. What side effects, if any, do participants have while taking these supplements? Researchers will compare Quercefit® (500 mg/day), Ubiqsome™ (300 mg/day), and a placebo (a look-alike capsule with no active ingredient). Participants will: 1. Take their assigned capsules (Quercefit®, Ubiqsome™, or placebo) twice daily for 12 weeks 2. Go to a preferred clinic at the start and end of the study for a fasting blood draw Complete at-home tests: 3. Grip strength testing (using a device mailed to them) 4. Online surveys about fatigue and quality of life 5. Report any side effects and keep track of supplement use

Radicle HealthTM VIP: A Study Assessing the Impact of Health and Wellness Products on Metabolic Health and Related Health Outcomes

Radicle HealthTM VIP: A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on metabolic health and related health outcomes.

Women's Hormonal and Metabolic Wellbeing Study

The goal of this clinical trial is to learn if Daily Nouri Hormone Balance Probiotic blend can improve metabolic, inflammatory, and symptom outcomes in women. Participants will: * Take the probiotic blend or placebo every day for 12 weeks * Complete virtual assessments and report symptoms throughout the study

Defining the Human Insulin Resistance Molecular Network; SIGNATURE

The goal of this intervention study is to learn more about what causes insulin resistance in otherwise healthy adults, and how short-term changes in physical activity or diet may influence it. The study includes healthy male and female participants aged 25 to 55 years, who meet specific health criteria. The main questions it aims to answer are: Does the cause of insulin resistance vary between individuals due to their genes and lifestyle? Can the investigators identify different types (sub-phenotypes) of insulin resistance at the molecular level? Researchers will compare groups who either reduce their physical activity for 14 days or consume a high-fat diet for 3 days, to see how these changes affect insulin sensitivity and related biological markers. Participants will: * Complete a health screening and be assessed for eligibility * Undergo baseline testing to measure insulin sensitivity, physical activity, diet, and metabolic health * Be randomly assigned to one of two short-term interventions (14 days of reduced physical activity, or 3 days of a high-fat, high-calorie diet) * Repeat selected tests after the intervention to assess changes This study will help researchers better understand how lifestyle and biology interact in the development of insulin resistance, even in people who are otherwise healthy.

A Clinical Trial to Evaluate the Effects of A Supplement on Supporting Signs of Metabolic Health

This study evaluates the effects of the Love Wellness supplement Hello Burn Activate on supporting metabolic health in adult females. The 12-week, single-arm, open-label, virtual trial will enroll 40 female participants aged 25-45 who are experiencing challenges with healthy weight management and body confidence. All participants will take one capsule of the test product daily in the morning with their first meal. Participants will complete self-reported questionnaires at Baseline, Week 4, Week 8, and Week 12 to assess changes in perceived metabolic health, body confidence, overall health, and well-being.

Diet, Metabolic Health, and Exercise Responses

Regular physical activity, healthy dietary habits, and good metabolic health are associated with numerous physical and cognitive health benefits. However, individuals vary substantially in their affective, motivational, and cognitive responses to exercise, and the factors contributing to this variability are not fully understood. This prospective observational study will examine whether habitual dietary fat quality and metabolic health are associated with exercise responses, cognitive function, and academic-related outcomes in healthy young adults. Participants will complete assessments of dietary intake, body composition, metabolic health, aerobic fitness, cognitive function, and academic engagement. They will also complete a standardized moderate-intensity cycling session during which affective responses, exercise enjoyment, subjective energy, and motivation for future physical activity will be assessed. The findings will improve understanding of how habitual dietary habits and metabolic health may influence responses to exercise and cognitive functioning and may help inform future lifestyle recommendations aimed at promoting physical activity participation, cognitive performance, and overall health.

HIIT, Cardiorespiratory Fitness, and Metabolic Health in Healthy Young Adults

The purpose of this study was to investigate the effects of a high-intensity interval training (HIIT) intervention on cardiorespiratory fitness (CRF) and cardiometabolic health in active male university students. The main question it aims to answer is: Does HIIT improves CRF and cardiometabolic outcomes, including blood pressure, lipid profile, and insulin resistance estimated using the homeostasis model assessment of insulin resistance (HOMA-IR). Researchers will compare HIIT (designed to experimental group) to non-training intervention (designed to control group) to see if the training program works to improve the cardiometabolic health status. The HIIT program consisted of three sessions per week for 9 weeks, comprising of three sets of six to eight 30-second running bouts performed at 100-110% of maximal aerobic speed (MAS), interspersed with 30-second active recovery runs at 50% MAS between bouts.

Health Benefits of Dance Exercise

In Greece, people of different age groups, including young children to older adults, participate in dance exercise training. Although it is well-known that regular participation in dancing is associated with benefits such as entertainment, socialization and increased physical activity, the long-term effects of dancing on metabolic and mental health as well as physical performance remain largely unknown. Therefore, the aim of this study is to investigate the effects of a 6-month dancing exercise intervention on metabolic and mental health and physical performance in premenopausal and postmenopausal women.

A Clinical Trial to Evaluate the Effects of a Plant-Based Liquid Supplement on Metabolic Health and Overall Well-Being

This single-arm clinical trial will evaluate the effects of a plant-based liquid supplement on metabolic health, digestive health, skin health, and overall well-being. Twenty participants aged 40 to 60 years with elevated alanine transaminase (ALT) or aspartate transaminase (AST) levels will use the supplement daily for 90 days. Participants will complete questionnaires, provide body composition and waist circumference measurements, submit photographs, and undergo blood testing throughout the study. Outcomes include changes in metabolic biomarkers, body composition, digestive symptoms, skin health, and overall well-being.

A Study to Evaluate a Supplement Combination in Supporting Weight Loss, Metabolic Health, and Quality of Life

This consumer-use study evaluates the effects of a combined postbiotic and prebiotic supplement regimen on appetite control, cravings, metabolic health, energy, and quality of life in adults aged 18-65 years with a body mass index (BMI) between 25 and 30. Participants will consume one capsule of resM™ GLP-1 Postbiotic and one scoop of resG prebeet ENERGY Prebiotic daily for 60 days. Data will be collected through daily check-ins, weekly surveys, and quality-of-life questionnaires administered through the Chloe mobile application. The primary objective is to evaluate changes in appetite control and food cravings over 60 days of supplementation.

Effect of Dairy Protein Yogourt vs Plant-based Yogourt on Body Weight, Body Composition, Bone Health and Gut Microbiota

The consumption of an adequate quantity of protein in the diet is essential to maintain a healthy body composition and functioning. It is also well established that all proteins are not equal regarding their ability to promote health benefits. Recently, we have innovated in that matter by showing that under the context of high intake of dietary fat, the dairy protein casein was more effective than a mix of proteins representative of a western diet to prevent body weight gain and insulin resistance. This was explained in part by modifications of the gut microbiota. This finding represents the main conceptual basis of the present research program that is aimed to determine the impact of dairy protein from yogurt compared to a plant-based equivalent on body composition indicators including muscle mass and bone mineral density, in relation to the profile of the gut microbiota, the production of newly discovered protein-derived metabolites, and markers of metabolic health. This program will include a human and an animal component requiring the testing of these variables before and after a standardized intervention. The human component will be a clinical study consisting of a 12-week diet-based weight loss intervention in postmenopausal overweight women being randomly assigned to one of the three following groups: yogurt, plant-based yogurt, or kept on diet without supplements. The animal experimentation will permit to causally determine the implication of the gut microbiota in the protein effects following transfer of the human bacteria to germ free mice and validate the benefits seen in humans. It is anticipated that these two complementary investigative approaches will allow a thorough documentation of the impact of fermented dairy protein on body composition and functioning, a better understanding of the underlying mechanisms, and the identification of new biomarkers to better appreciate related health benefits.

The SWITCH (Substitution of High With Low Ultra-processed Soy Protein Foods In a Guideline-based Diet inTervention for Cardiometabolic Health) Trial

This is a randomized, controlled, parallel study with 3 experimental arms aimed to assess the effect of a digital dietary intervention (web-based app, online behavior change curriculum) enhanced with 10 servings of vegetables and fruit (5 as dietary advice within the app, 5 within a dehydrated vegetable and fruit blend), with or without high Ultra Processed Food (UPF) soy-containing proteins compared to standard of care (usual care) on systolic blood pressure (SBP; primary outcome), and other key cardiometabolic endpoints over 12-weeks in adults living with hypertension and obesity, 50% with type 2 diabetes. The main questions this study aims to answer are: 1. Are nutrient-dense, high-UPF soy-protein foods similar (non-inferior) to low-UPF soy-protein foods in the context of a guidelines-based diet in their effect on blood pressure and other cardiometabolic risk factors? 2. Does an enhanced digital dietary intervention lead to meaningful reductions in blood pressure and other cardiometabolic risk factors compared to standard of care? Participants who are eligible and consent to be part of this study will be randomized to one of the following groups: 1) Active treatment (high-UPF soy-containing enhanced digital dietary intervention), 2) Reference treatment (low-UPF soy-containing enhanced digital dietary intervention), or 3) Control (standard of care). Participant Requirements: During the 12-week intervention, all participants will be required to attend in-person clinic visits at baseline (week 0), week 8 and 12. Baseline Visit (Week 0): Participants will be asked to arrive in a fasted state (no food or beverages, except water, for 10-12 hours before the visit). * Undergo various assessments, including anthropometric measurements, office blood pressure readings, and blood sampling (via a capillary finger prick and blood sample taken by the study nurse). * Review the 7-day food records completed using the Keenoa mobile app one week prior to clinic visit. * Bring fecal and urine samples from home. * Complete and review all questionnaires received via email one week prior. Telephone Check-in (Week 1): One week after beginning the study, the study staff will call participants to check in on how participants are following the protocol and answer any questions. Mid-Study Visit (Week 8): Participants will be asked to arrive in a fasted state (no food or beverages, except water, for 10-12 hours before the visit). * Have their office blood pressure and anthropometric measurements taken. * Complete and review all questionnaires received via email one week prior * Review the 3-day food records completed using the Keenoa mobile app one week prior to clinic visit. Final Study Visit (Week 12): Participants will be asked to arrive in a fasted state (no food or beverages, except water, for 10-12 hours before the visit). * Undergo various assessments, including anthropometric measurements, office blood pressure readings, and blood sampling (via a capillary finger prick and blood sample taken by the study nurse). * Review the 7-day food records completed using the Keenoa mobile app one week prior to clinic visit. * Bring fecal and urine samples from home. * Complete and review all questionnaires received via email one week prior. Throughout the study, participants will be asked to continue their usual lifestyle and physical activity. Additional Requirements for Treatment Groups: Participants randomized to the active and reference treatment groups will also be required to: * Incorporate a study vegetable and fruit blend (provided) into their daily diet for the full 12 weeks * Consume soy products categorized as either high ultra processed soy foods at least 4 servings per day, including at least 2 servings of ultra processed soy milk and 2 servings of other soy-based products (e.g., soy yogurt, soy burgers, or soy ground round) or non-ultra processed soy foods at least 4 servings per day, including at least 2 servings of minimally processed soy milk, 1 serving of edamame or roasted soy nuts, and 1 serving of tofu or tempeh * Participate in the digital dietary intervention, which includes: a health app, 7-day Kickstart Package, weekly text message support, and a 7-session online interactive program designed based on behaviour change theory * Attend a virtual focus group at Week 4 and complete an online feedback questionnaire

St Mary's Assisted Reproductive Technology and Cardiometabolic Health: Modifiable Targets for Multimorbidity Prevention (START-HEALThY)

The main causes of death in women are conditions affecting the heart and blood vessels (cardiovascular disease, CVD). Women who have difficulties getting pregnant (infertility) may be at increased risk, but the reasons for this are not clear. Infertility itself may be linked with poorer heart and blood vessel health, or fertility treatments such as in vitro fertilisation (IVF) could increase the risk. The study aims to understand the practicalities of obtaining detailed profiling of women's pre- and post- pregnancy heart, blood vessel and metabolic health. Two groups of women in Manchester University NHS Foundation Trust, will be recruited over 2 years: 1) women planning a pregnancy, either spontaneously or with IVF treatment after infertility, 2) women who previously took part in a pregnancy health study after IVF or non-IVF conception. Participants will attend a single research appointment where they will undergo a cardiometabolic health assessment. They will have their BMI calculated, body composition measured, a measurement of how well their blood vessels work using a blood pressure cuff around the arm and/or finger and blood sampling performed. A blood pressure cuff as well as a blood sugar sensor may be fitted to be worn after the appointment. Participants will be asked to complete a questionnaire(s), with follow-up for up to 13 months. The cardiometabolic health of those who conceived with or without IVF treatment and with or without a history of infertility will be compared at both time points to investigate the possibility of links between infertility, IVF processes and CVD risk and to understand any potential barriers to recruitment of individuals at either time point to guide future studies. This information could then be used in a full-scale study, including in pregnancy, to improve care and promote lifelong health for women with infertility.

Treating Insomnia and Improving Metabolic Health in Midlife Women With Insomnia

The aim of this study is to determine if suvorexant can help treat the severity of insomnia and improve metabolic health in midlife women who had both insomnia and indicators of metabolic syndrome.

ImpaCt Of Shiftwork on METabolic Flexibility and Skeletal Muscle Clocks

The purpose of this study is to determine the impact of real-world shiftwork on metabolic flexibility.

Impact of Protein Source and Polyphenol Complexation in Protein Bars on Metabolic Health

The goal of this clinical trial is to learn if pulse (pea) protein works similar to animal (whey) protein in protein bars consumed by healthy adults. The main questions it aims to answer are: What are the differences in taste and tolerance profiles between pea and whey proteins? What metabolic and immune changes do participants experience while eating them? What gastrointestinal microbiome shifts can be observed in these participants? How incorporation and complexation of polyphenols with these proteins changes the study outcomes? Participants will: Consume 1 protein bar with whey protein, pea protein, pea protein with complexed polyphenols, or pea protein with free polyphenols every day for 2 months. Visit the study site at baseline and end of study for checkups and tests. Fill dietary, food acceptance, gastrointestinal tolerance, and global health questionnaires.

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.

Effect of Prebiotics in Saudi Adults With Type 2 Diabetes

This study will explore how a natural food ingredient called oligofructose affects blood glucose levels, lipid profiles, inflammation biomarkers, and gut bacteria in Saudi adults with type 2 diabetes. Oligofructose is a type of dietary fiber found in foods such as onions, garlic, and bananas. It is known to help the growth of "good" bacteria in the intestine, which may improve digestion and metabolism. A total of 100 adults (50 with type 2 diabetes and 50 without diabetes) will take part in this research. Participants will be randomly assigned to receive either oligofructose or a placebo twice daily for 12 weeks. Blood tests will be done at the beginning and at weeks 4, 8, and 12 to check changes in blood glucose, lipid profiles, and inflammation. The goal of this study is to find out whether adding oligofructose to the diet can help people with diabetes improve their blood glucose control, reduce inflammation, and support a healthier balance of gut bacteria.