Clinical Research Directory

Improvement in Hepatic Function Through Sumac (Rhus Coriaria L.) Supplement Along With a Calorie-restricted Diet for the Management of Grade-I Obese Non-alcoholic Fatty Liver Disease Patients

This randomized controlled trial aims to evaluate the effects of Rhus coriaria L. (Sumac) supplementation combined with a calorie-restricted diet on hepatic function and metabolic health in grade-I obese patients with non-alcoholic fatty liver disease (NAFLD). A total of 102 participants aged 30-60 years with confirmed NAFLD will be randomly assigned to one of three groups: placebo, 1.5 g/day Sumac supplementation, or 3.0 g/day Sumac supplementation for 12 weeks. Outcomes will include changes in liver function tests (ALT, AST, and ALP), anthropometric measurements, glycemic control, insulin resistance, lipid profile, and inflammatory biomarkers. The study aims to determine whether Sumac supplementation provides additional benefits beyond calorie restriction alone in improving hepatic health and metabolic risk factors associated with NAFLD.

Effect of Low Dose Galactose on Glycaemia and Glucose Kinetics

This project will establish the degree to which adding low-dose galactose to a meal can control blood sugar levels. People will consume standardised glucose drinks (75g glucose, as an oral glucose tolerance test). People will consume these with and without the addition of galactose, and with the addition of another sugar (fructose) for an extra comparison. The investigators will use state-of-the-art labelling methods (dual stable isotope technology) to follow what happens to the glucose that is ingested and understand what happens to sugar being released by the liver and sugar being taken up by other tissues like the muscles. These methods can tell the investigators how the addition of galactose can control blood sugar levels. For example, the galactose could slow down the appearance of glucose from the gut and/or liver released into the blood, or it could increase the disappearance of glucose from the blood into muscles. The investigators will measure the appearance of the label on exhaled breath, which will establish whether ingested sugar is stored, or burned as fuel. The investigators will also explore other potential ways in which galactose might control blood sugar levels by measuring key hormones and metabolites that contribute to blood sugar control (for example, insulin, fatty acids, and incretin hormones which potentiate insulin secretion). This additional evidence of how galactose can control blood sugar levels will provide the understanding required to best make use of this approach across a variety of settings.

Comparative Efficacy of Intra-articular vs. MRI-guided Extra-articular Dextrose Injections in Knee Osteoarthritis Management

Osteoarthritis (OA) is a serious worldwide public health concern, causing increased disability-adjusted life years (DALY), the reasons of which include rising prevalence of obesity and increasing older populations. The knee is one of the most easily injured joint in the body, and knee OA can become a chronic and disabling condition that pose a threat to not only the patient but also his or her caretakers and healthcare resources. The prevalence of knee OA is 5% - 15% in men over 60 years, and 10% - 25% in women aged more than 60. Knee OA can result from injuries, diseases, or wear and tear from overuse. It refers to structural changes that affect subchondral bone, articular cartilage, menisci, ligaments, synovium, and other joint structures. Currently, there are several conservative management of knee OA, including physiotherapy (therapeutic exercise, diathermy, electrotherapy), oral or topical medications, intra-articular and extra-articular injections, and radiofrequency. There are various substances used in injections for knee OA, among which are corticosteroid, platelet-rich plasma (PRP), AmnioFix, exosome, dextrose, and hyaluronic acid (HA). Compared with PRP, AmnioFix, exosome, and HA, which are not covered by the health insurance system, dextrose is a readily available and cost-effective substance. The principle of hypertonic dextrose injection, "prolotherapy", is injection of small volumes of the irritant solution at or around the lesion in order to stimulate fibroblast and vascular proliferation, local tissue healing, reduction of joint instability, thus resulting in pain relief. Previous studies have demonstrated that prolotherapy resulted in clinically meaningful sustained improvement of function and pain in knee OA, and there were no severe adverse events related to hypertonic dextrose injection. A study in 2023 showed that among various dextrose concentrations, higher concentrations demonstrated greater improvement of knee OA, thus 20% dextrose is recommended. Regarding the site of dextrose injection in knee OA, previous studies demonstrated comparable effects of intra-articular and extra-articular injections. The periarticular injections include points around the knee where periarticular nerves exit the joint capsule, and acupuncture points at upper medial and lateral parts of knee joint. A study in 2024 revealed that prolotherapy combining intra-articular with peri-articular perineural injection resulted in better pain alleviation and improvement in knee joint function in knee OA. There are several choices of imaging modality for recognizing the sites of lesion in knee OA, such as X-ray, ultrasound (US), and magnetic resonance imaging (MRI). Radiography is used to assess osteophytes, joint space narrowing, and subchondral sclerosis, but it has limited ability to detect synovial inflammation, joint effusion, soft tissue abnormalities, and early cartilage damage. US can be used to evaluate synovial fluid and cartilage thickness, but not deep structures (e.g. subchondral bone change, meniscus tear, and ACL tear, etc.). On the other hand, MRI is an optimal and accurate imaging choice for visualizing soft tissue as well as deep structures (e.g. ACL, meniscus, etc) in knee OA. The MRI findings of knee OA includes cartilage damage, meniscus tear, bone marrow lesions, synovitis, ligamentous laxity, and osteophytes. The detection of bony lesions can aid intraosseous Infiltrations, and signs of ligamentous laxity also provides target for ligaments injection. However, there is no current evidence on the effectiveness of prolotherapy targeting knee OA lesion sites according to MRI findings. Because the effectiveness of prolotherapy targeting lesion sites according to MRI findings has not been well established, the investigators aim to investigate whether injecting dextrose into MRI-positive lesion sites is more beneficial for knee OA comparing to intra-articular injections. The investigators hypothesize that MRI could be a good choice for the guidance of prolotherapy targets.

Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health

The purpose of this Phase 1 research study is to answer two questions: (1) How frequent should periods of prolonged sedentary time be interrupted? and (2) What is the appropriate duration or length of time of these breaks in sedentary time? To address these questions, this project will conduct a state-of-the-art adaptive dose finding study under controlled laboratory conditions to determine the minimally effective dose (the smallest dose) that yields cardiometabolic benefit for two separate sedentary break elements (frequency and duration). Study findings will ultimately determine how often and for how long people should break up periods of prolonged sedentary time to transiently improve established cardiovascular risk factors; key foundational information critical to the success of future long-term trials and ultimately public health guidelines. Primary Aim: To determine the minimally effective dose combination(s) of frequency and duration needed to provide cardiometabolic benefit during an 8-hour experimentation period. Specifically, the study will determine: 1a. For each fixed duration, the minimum sedentary break frequency (e.g., every 30 min, 60 min, 120 min) that demonstrates a reduction in systolic BP, diastolic BP, or glucose compared with a sedentary control condition. 1b. For each fixed frequency, the minimum sedentary break duration (e.g., activity breaks of 1 min, 5 min, 10 min) that demonstrates a reduction in systolic BP, diastolic BP, or glucose compared with a sedentary control. Secondary Aim: It is also critical to public health strategy to assess the acceptability/feasibility of various sedentary break doses as too high a dose will yield poor uptake. To address this need, the maximally tolerated dose (the highest dose that does not cause undue physical/psychological distress) for frequency and duration of sedentary breaks will also be determined via assessment of 4 constructs: physical exhaustion/fatigue, affect (e.g., mood, emotion), tolerability (e.g., completion of dose protocol), and safety (e.g., hypoglycemia). Maximally tolerated dose will be defined as the highest dose where \<20% of participants exhibit an adverse outcome.

Timing of Broccoli Sprout Intake to Improve Exercise Performance

This study examines how the timing of intake of a broccoli sprout-based drink (a natural source of isothiocyanates, ITCs) affects physiological responses, recovery, and performance after a standardized endurance cycling session. Healthy, endurance-trained adults (18-64 years) will complete four laboratory visits at the Swedish School of Sport and Health Sciences (GIH): one screening/physiology test visit and three intervention visits in a randomized, double-blind, placebo-controlled cross-over design. On intervention visits, participants will ingest either an active broccoli sprout drink (50 g sprouts) or a placebo drink based on alfalfa sprouts (50 g sprouts) according to randomization. The drink will be consumed either approximately 16 hours before exercise (the evening before) or approximately 3 hours before exercise (the morning of the test), enabling comparison of timing in relation to a standardized \~2-hour cycling protocol (individualized intensity) followed by a 10 km cycling time trial. Outcomes include measures of performance, heart rate, perceived exertion and recovery, blood glucose and lactate, and metabolic responses. Venous blood samples are collected at multiple time points before and after exercise and during the subsequent laboratory recovery period, and muscle biopsies are obtained at defined time points to assess muscle metabolism and recovery-related markers. Participants return \~24 hours after exercise for follow-up sampling after an overnight fast, including a glucose tolerance test

Tracing Of Real-time glu13Cose Metabolism in Human Immune Cells

The purpose of this study is to understand how cells of the immune system use the common sugar glucose to fuel energy production and as a building block within the cell. Investigators will intravenously infuse a non-radioactive glucose tracer into participants over a few hours and collect immune cells from the blood to track uptake and usage of this glucose within these immune cells.

Assessing the Value of Avocados on Glycemic Control in Type 2 Diabetes

The objective of this study is to assess the effects of Hass Avocados on glycemic control. The investigators hypothesize that Hass Avocado consumption will reduce fasting blood sugar compared to an isocaloric amount of other fruit during controlled feeding.

Childhood Obesity Prevention Project in Gran Canaria

Given the alarming rates of obesity and overweight in our child population, the investigators have developed an intervention strategy, based on a multidisciplinary, school-centered approach, which addresses nutritional education, physical activity, behavioral intervention techniques and tools that facilitate the learning of healthy lifestyle habits in children between 6 and 10 years of age.