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NCT ID: NCT06333184 Recruiting - Clinical trials for Metabolic Disturbance

Smoothies and Blood Sugars

Start date: March 20, 2024
Phase: N/A
Study type: Interventional

Glycaemic responses to fruit smoothies may depend on the food matrix (e.g., degree of processing and physical structure), ingestion rate, dose ingested and fibre content. Furthermore, the method of sampling could alter inferences. The aim of this project is to characterise how these factors affect the glycaemic response to a commercially available fruit smoothie. Participants will ingest 7 different test drinks in a randomised, crossover design with fingerstick capillary blood sampling alongside continuous glucose monitors. Test drinks will include a glucose reference (CONTROL), the commercial product matched for carbohydrate to CONTROL (PRODUCT), equivalent carbohydrate ingested as whole fruits (WHOLE), equivalent carbohydrate ingested as blended fruits (WHOLE), equivalent carbohydrate as the commercial product ingested slowly (SLOW), equivalent carbohydrate as the commercial product ingested with additional fibre (FIBRE), and the commercial product ingested in a dose typically bought (DOSE). These data will provide insight into how the food matrix and different patterns of ingestion can alter the glycaemic response to a fruit smoothie, and how the measurement method may alter interpretations.

NCT ID: NCT06330623 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Developing Personalised Relative Physical Activity Thresholds in COPD.

IMPACT
Start date: November 22, 2023
Phase:
Study type: Observational

The aim of this observational study is to translate the principle of individualised exercise prescription into the evaluation of daily absolute and relative intensity physical activity. The main questions this study aims to answer are: - Phase 1: What does physical activity (intensity) mean to people with COPD? - Phase 2: Are there differences between time spent in absolute and relative physical activity for people with COPD? Phase 1 Participants will take part in semi-structured interview (30-45 minutes) about living with COPD and perceptions of physical activity and how they perceive intensity. This will also include photovoice and photo-elicitation. Demographic information will be recorded and participants will also complete several respiratory symptom questionnaires. Phase 2: Participants will take part in physical activity testing before and after pulmonary rehabilitation while wearing physical activity monitors. Demographic information will be recorded and participants will also complete several respiratory symptom and physical activity questionnaires. Participants will also wear the physical activity monitors for 8 days after the pre-testing sessions and after their final pulmonary rehabilitation class. Sub-study: Participants will be asked to take images of barriers during physical activity, facilitators during physical activity, feelings during physical activity and types of physical activity they take part in for 8 days after their final pulmonary rehabilitation class. Participants will then take part in a semi-structured interview about the images their have taken while doing physical activity.

NCT ID: NCT06329895 Recruiting - Healthy Volunteers Clinical Trials

A Study to Learn About How BAY2927088 Affects the Level of Dabigatran or Rosuvastatin in the Blood When These Drugs Are Taken Together in Healthy Participants

Start date: March 25, 2024
Phase: Phase 1
Study type: Interventional

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins, like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer. In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations. BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer. Researchers think that BAY2927088 inhibits drug transporters such as P-gp (P-glycoprotein) and breast cancer resistance protein (BCRP). Drug transporters are proteins that help in the movement of certain drugs into, through, and out of the body's cells. Dabigatran is a drug used in the treatment of blood clots in a vein and rosuvastatin is a drug used in the treatment of high cholesterol in the blood. The main purpose of this study is to find out how BAY2927088, taken as multiple doses, affects the levels of dabigatran and rosuvastatin in the blood of healthy participants. For this, researchers will measure the following for dabigatran and rosuvastatin, when given with and without BAY2927088: - Area under the curve (AUC): a measure of the total amount of the drug in participants' blood over time - Maximum observed concentration (Cmax): the highest amount of the drug in participants' blood In this study, participants will take the following treatments: - Dabigatran in the morning of Day 1 and 9. - Rosuvastatin in the morning of Day 3 and 12. - BAY2927088 two times a day in the morning and evening of Days 6 to 15. Participants will be in this study for about 8 weeks with 3 visits to the study clinic. Participants will visit the study clinic: - at least once, 2 to 28 days before the treatment starts, to confirm they can take part in this study - once on the day before the treatment starts and will stay in the clinic until Day 16 of the treatment - once, 7 to 10 days after last dose of BAY2927088, for a health check-up During the study, the doctors and their study team will: - do physical examinations - collect blood samples from the participants to measure the levels of dabigatran, rosuvastatin and of BAY2927088 - check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG) - ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

NCT ID: NCT06329804 Recruiting - Blood Pressure Clinical Trials

The Dose Response Effect of Isometric Handgrip Training Frequency on Blood Pressure in Normotensive Individuals

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

It is estimated by WHO (2021) that 1.4 billion individuals across the globe have high blood pressure with only 14% of people managing these elevated levels. Simple and effective lifestyle strategies are required to help people improve their blood pressure and/or attenuate increases in blood pressure with ageing. Exercise is one possible strategy: in previous research, several different types of exercise have been shown to have effects on blood pressure (Blackwell et al., 2017). However, many individuals do not adhere to currently recommended levels of exercise (150 mins of moderate intensity exercise per week), due to a combination of the required time commitment, lack of motivation, and the associated levels of effort / exertion and discomfort (Korkiakangas et al 2009). Thus, there is a need to investigate alternative exercise interventions which will overcome these barriers but remain effective at improving blood pressure (Herrod, Lund, & Phillips, 2021). Low intensity isometric hand grip training (IHGT) has been shown to result in large decreases in rest-ing blood pressure in younger and older age groups, in both men and women, and in individuals with normal as well as elevated baseline blood pressure (Badrov et al, 2013; Bentley et al., 2018; Millar et al., 2014). In this research, IHGT has typically involved performing 4 x 2 IHGT holds at 30% of maximal voluntary contraction, 3 times a week, over a 4-8-week intervention (Millar et al, 2014). Interestingly, there are very few studies that have investigated the effect of changing different protocol parameters on the adaptations in blood pressure, and the minimal effective dose of IHGT is unknown. One important modifiable parameter is training frequency and it is unknown whether reducing the frequency of IHGT will reduce the efficacy for improving blood pressure. Therefore, the aim of this randomised controlled trial is to compare the effect of IHGT with a frequency of 2 or 4 sessions/week on resting blood pressure.

NCT ID: NCT06324669 Recruiting - Type 2 Diabetes Clinical Trials

The Effect of a Ketone Drink on Blood Glucose Levels in People With Type 2 Diabetes

Start date: March 16, 2024
Phase: N/A
Study type: Interventional

Ketones are naturally produced by our body and can affect our blood sugar levels. Ketones could be important in the treatment of type 2 diabetes (T2D). The purpose of this research is to determine if a ketone drink can lower blood sugar in people with T2D following a meal. This research will provide new knowledge about the regulation of blood sugar. This may also inform if ketone drinks could be used as a treatment for T2D.

NCT ID: NCT06322160 Recruiting - Thyroid Cancer Clinical Trials

The Role of tHyroid cAncer Specific Patient Concerns iNventory (PCI-TC) in Enhancing Shared decisiOn Making

HANSOM
Start date: May 3, 2023
Phase:
Study type: Observational

Multiple clinical equipoises exist for the management of thyroid cancers. Shared decision-making (SDM) process where patients are supported to consider options, to achieve informed preferences with their clinicians have been recommended to improve patients' satisfaction and their overall quality of life. However, SDM can be difficult to achieve in our standard clinical encounters due to clinician's lack of confidence and time limitation to elicit patient's concerns and preferences. PCI as a decision-making support tool has shown to enhances clinician's awareness of patient's needs and allows for a more effective communication while the consultation time is unaffected. The successful development, testing and implementation of a PCI-TC could improve patient satisfaction, clinical efficiency and ensure that unmet need is appropriately addressed. This study will support the development of PCI-TC to better understand the wide-ranging needs of our patients and to improve the SDM process in the thyroid cancer management pathway.

NCT ID: NCT06321887 Recruiting - Clinical trials for Inflammatory Bowel Disease

EffiCacy and sAfEty of Low doSe orAl iRon for Anaemia in IBD

CAESAR
Start date: October 20, 2023
Phase: Phase 3
Study type: Interventional

Iron deficiency anaemia (IDA) is common in inflammatory bowel disease (IBD). However, although iron is commonly prescribed, the amount of elemental iron needed to achieve clinical efficacy, and the optimal method of supplementation, are under debate. This pilot study aims to investigate the efficacy and safety of low dose and standard dose oral iron preparations for the treatment of IDA in patients with IBD.

NCT ID: NCT06321458 Recruiting - Obesity Clinical Trials

Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity

LightWAY
Start date: April 29, 2024
Phase: N/A
Study type: Interventional

In this trial, the aim is to assess the clinical benefits and harms, as well as cost-effectiveness of an intensive weight loss (IWL) intervention that includes total dietary replacements, behavioural support and weight-loss medication compared with existing weight management programmes within primary care for people with severe and complex obesity.

NCT ID: NCT06320535 Recruiting - Malaria,Falciparum Clinical Trials

A Phase 1 Study to Assess an Escalating Dose, Multi-prime Vaccination Schedule of R21/Matrix-M™

Start date: March 25, 2024
Phase: Phase 1
Study type: Interventional

This is a phase I clinical study that aims to assess the safety and immunogenicity of a novel, escalating dose regimen of R21/Matrix-M™ in healthy, malaria-naïve adults.

NCT ID: NCT06320522 Recruiting - Ketosis Clinical Trials

Exogenous Ketosis in a Fed and a Fasted State

Start date: February 15, 2023
Phase: N/A
Study type: Interventional

The kinetics of circulating βHB following ingestion of the ketone monoester are dependent on several variables that determine the balance between appearance into, and disappearance from, the bloodstream. These dynamics have been well characterised in fasted humans but in the real world the ketone monoester is likely to be ingested in a fed state, pertinently within athletic spheres consumption would proceed a substantial high-carbohydrate meal. Within this, it is unclear how metabolism under exogenous ketosis might be affected in a fed versus fasted state. This four-arm crossover study looks to characterise the relationship between feeding status, βHB pharmacokinetics, and resting metabolism. As exogenous ketosis is known to reduce circulating glucose levels, this study will also explored if hepatic metabolism - for example, de novo lipogenesis - might consequently be altered, with implications for metabolic disease states such as Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and type II diabetes. Participants will be asked to consume either the ketone monoester drink or a placebo drink when fasted and when having previously consumed a meal.