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Ketosis clinical trials

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NCT ID: NCT05939011 Completed - Ketosis Clinical Trials

Ketogenic Diet Health and Longevity

KDHL
Start date: April 8, 2022
Phase: N/A
Study type: Interventional

The goal of this pilot intervention is to learn about how a well-formulated ketogenic diet (WFKD) impacts various health factors in generally healthy adults. The main questions it aims to answer are: - Establish whether an 8-week isocaloric, WFKD improves body composition and metabolic biomarkers in adults without chronic disease. - Examine changes in transcriptomic sequencing pathways pre- and post-WFKD intervention. - Explore gut microbial changes in adults without chronic disease that consume a WFKD. Participants will follow a well-formulated ketogenic diet for 8-weeks. Study procedures include: - Weekly body weight tracking - Daily urinary ketone assessment - Pre/post stool samples for gut microbiota analyses - Pre/post DXA scans - Diet quality tracking through 3-day food records

NCT ID: NCT05932420 Active, not recruiting - Clinical trials for Exercise Adaptations

Role of Intermittent Exogenous Ketosis in the Physiological and Muscular Adaptive Response to Endurance Training

Start date: October 1, 2022
Phase: Phase 2
Study type: Interventional

In a recent study (Poffé et al., 2019), we demonstrated that increasing the concentration of ketone bodies in the blood through the ingestion of a ketone ester (KE) post-exercise and just before sleeping time during a 3-week overtraining period resulted in suppression of the physiological symptoms of overtraining. Consistent KE intake improved endurance performance, positively affected the autonomic regulation of the heart, suppressed the increase of nocturnal sympathetic activity, and increased spontaneous energy intake. In addition, KE intake had a positive effect on muscular adaptive response, as evidenced by the significantly increased muscular angiogenesis. Therefore, in this study, we aim to investigate whether the oral administration of ketones after exercise and just before bedtime also has a positive effect on the adaptive response during a well-dosed endurance training program. Since suppression of nocturnal sympathetic activity can positively influence sleep quality, we will also study the effect of KE and the training period on sleep quality. To investigate this, we will use a randomized, placebo-controlled parallel research design. Well-trained male cyclists will participate in a fully controlled intervention period of 8 weeks. During the intervention period, participants will follow a supervised cycling training program (5-7 training sessions per week) with a gradual buildup aimed at improving endurance capacity. Throughout the intervention period, participants will ingest 25g ketone ester or a corresponding placebo after each training session and 30 minutes before bedtime. Endurance performance will be evaluated before the start of the training period (pretest), after week 3 (midtest), after week 7 (posttest) of the training period, and at the end of the training intervention (posttest+taper). Additionally, blood samples will be taken at the pre-test and post-test to analyze markers of hormonal status and inflammation. Muscle biopsies will be taken from the vastus lateralis muscle of the right leg at pretest and posttest to analyze cross-sectional area, muscle fiber typing, angiogenesis, protein synthesis and degradation, mitochondrial function, and energy substrate concentrations. One month after the intervention period, an additional biopsy will be taken to study changes in gene expression (epigenetic modifications). Sleep will be evaluated via polysomnography (PSG) at the pretest, midtest and posttest. Finally, before and after the training period, resting and exercise echocardiography will be taken to investigate investigate structural and morphological changes of the heart.

NCT ID: NCT05924295 Recruiting - Ketosis Clinical Trials

Variations in Ketone Metabolism

STAK-VKM
Start date: June 20, 2023
Phase: N/A
Study type: Interventional

This outcome of this study will elucidate how the phenotype of the individual modulates the KE metabolic effect. Most studies of KE have been in homogenous populations, usually young, male athletes. However, two striking experiments using identical, body weight adjusted KE doses in healthy and obese individuals found that BHB area under the curve (AUC) and removal was reduced by obesity and poor metabolic health. Similarly, ketone infusion experiments found that diabetes, obesity, and insulin resistance alter BHB metabolism. It is important to determine how obesity affects KE 'sensitivity' (i.e., breakdown and oxidation) because the increasing prevalence of obesity as a function of age. Age may be another important source of variation in ketone metabolism. The genes that control the ketone system are regulated by a cascade of transcription factors and hormones including PPARα and FGF21, which are themselves known to be affected by aging and dietary status, and the cellular protein sensor target of rapamycin (TOR). Aberrant hyperactivation of TOR with aging may reduce ketogenesis, while it was observed that a long-term ketogenic diet specifically up-regulated PPARα activity. Preliminary work revealed substantial changes across mouse lifespan in the expression of ketone-related genes in the liver such as Hmgcs2 (rate limiting for ketone production) and Bdh1 (rate limiting for BHB oxidation) between young, middle-aged, and old mice, with a nadir of gene expression in middle age before increasing again late in life. Substantial age differences were found in response to matched doses of oral KE in mice and in rats. These data may have important implications for treating people of different ages and for translating KE technologies into the Department of VA. Therefore, this project plans to study individual responses to KE ingestion across the lifespan, against the background of varying metabolic health

NCT ID: NCT05867797 Not yet recruiting - Acute Kidney Injury Clinical Trials

Risk Factors and Outcomes of Acute Kidney Injury in Patients With Diabetic Ketoacidosis at Sohag University Hospital.

Start date: May 20, 2023
Phase:
Study type: Observational

Diabetic ketoacidosis (DKA), a severe complication of diabetes mellitus (DM), is the leading cause of hospitalization, morbidity and mortality in patients with DM (1). DKA is associated with hyperglycemic crises and featured by metabolic acidosis, the production of ketoacids, volume depletion, and electrolyte imbalance. Due to glucose-induced osmotic polyuria and even emesis, volume depletion is a major cause of acute kidney injury (AKI) in DKA patients (2).

NCT ID: NCT05808972 Completed - Acetonuria Clinical Trials

0.9% Saline Versus Balanced Solutions in Severe Diabetic Ketoacidosis

Start date: November 1, 2022
Phase: Phase 4
Study type: Interventional

Severe diabetic ketoacidosis (DKA) is a potentially serious complication of diabetes mellitus. The treatment regimen is based on insulin and rehydration. The choice of rehydration solution is a question that remains open. We sought to compare the effect of sodium chloride 0.9% (SC) versus ringer lactate (RL) in the resolution of severe DKA as well as on the variation of electrolytes.

NCT ID: NCT05752279 Not yet recruiting - Clinical trials for Diabetic Ketoacidosis

Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis

BEST-DKA
Start date: March 2024
Phase: Phase 3
Study type: Interventional

The goal of this blinded, cluster cross-over, randomised controlled trial is to determine whether fluid therapy with Plasma-Lyte® 148 increases the number of days alive and days out of hospital to day-28 compared to 0.9% sodium chloride ('0.9% saline') in critically ill patients presenting to the Emergency Department (ED) and deemed to require admission to a critical care area (ICU, HDU) with moderate to severe diabetic ketoacidosis (DKA).

NCT ID: NCT05732909 Recruiting - Aging Clinical Trials

The Metabolic Effects of β-hydroxybutyrate on Working Skeletal Muscle

Start date: December 22, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test ketone bodies in healthy elderly and young individuals. The main question it aims to answer are: • Do ketone bodies improve skeletal muscle function? Participants will ingest a ketone monoester and skeletal muscle function will then be evaluated by: - Special magnetic imaging techniques - Intravenous infusion of tracer-marked nutrients - Performance tests on a ergometer bike and in a dynamometer Researchers will compare the outcomes between within the young and elderly groups and between the young and the elderly group to investigate if age has an effect on the outcomes.

NCT ID: NCT05699707 Completed - Ketosis Clinical Trials

Metabolomic Signature of Exogenous Ketosis

KM
Start date: February 1, 2023
Phase: N/A
Study type: Interventional

Ketone bodies are a fuel source and signaling molecule that are produced by your body during prolonged fasting or if you consistently eat at low-carbohydrate diet. Blood ketones can be used as a source of energy during fasting and are used by your brain as an alternative source of fuel to glucose. Previous studies have found that ketones, when consumed in form of a supplement drink, can increase blood ketone levels and lower blood glucose, the amount of sugar in your blood. This is of potential interest for individuals with high blood sugar, such as people living with type 2 diabetes. However, how ketone supplements impact metabolism is not fully understood but using high throughput analysis techniques that can characterize hundreds to thousands of metabolites in the blood (known as "metabolomics") may allow researchers to discover novel compounds within the body that are altered by ketone supplements. This will improve our understanding of how ketones impact metabolism and guide future research.

NCT ID: NCT05689697 Not yet recruiting - Patient Activation Clinical Trials

Induced Physiological Ketosis in Asthenia and\or Decreased Tolerance to Physical and\or Mental Exertion

Start date: January 9, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is evaluating of efficacy of innovative dietary strategy -stimulation of physiological ketosis with Liquid Technology Formula PanTrek, in patients with asthenia and or decreased tolerance to physical and\or mental exertion. PanTrek is a liquid formula of potassium and magnesium salts of beta-oxibutiric acid, ginsenosides and rosmarinic acid.

NCT ID: NCT05666895 Not yet recruiting - Clinical trials for Diabetic Ketoacidosis

Role of CBC as a Prognostic Marker for DKA Patients

Start date: January 1, 2023
Phase:
Study type: Observational

1. To evaluate that change of platelet-to-lymphocyte Ratio affect the duration of hospital stay and mortality rate of DKA patients 2. To assess the impact of red blood cell distribution width (RDW) on the prognosis of diabetic ketoacidosis patients 3. To evaluate the changes in hematological parameters (RBCs,Hct,Hb,MCV,PLT,WBCs) and their correlations with acidosis level and dehydration during ketoacidosis treatment