Ketosis Clinical Trial
Official title:
Pre-meals of 3-hydroxybutyrate for People With Type 2 Diabetes
Hyperglycemia following meals in patients with type 2 diabetes mellitus (T2DM) is a common problem. Recently, our group found that oral consumption of the ketone metabolite, 3-hydroxybutyrate (3-OHB), effectively stimulates insulin secretion and delays gastric emptying.The aim of this study is to investigate the dose/response relationship between 3-OHB servings of 0, 10, 20 and 40 grams 30 minutes before an OGTT and, ii) investigate the role of timing by serving 20 grams of 3-OHB at different timepoints ahead of an OGTT (0, 30 and 60 minutes)
Hyperglycemia following meals in patients with type 2 diabetes mellitus (T2DM) is a common problem, which can cause discomfort and fatigue but may also lead to diabetic complications. Small servings of macronutrients, especially protein-rich products, before a main meal (= pre-meals) has been shown to significantly lower postprandial glucose excursions in both healthy individuals and patients with T2DM. The reductions are primarily attributed the fact that protein stimulates insulin secretion and delays gastric emptying. The timing and dose of a premeal are essential for the glycemic reductions following a meal 4. Unfortunately, it often requires a rather large amount of protein (> 50 g) to facilitate clinically relevant reductions in postprandial glucose levels and a large protein intake may be unwanted for some patients (i.e., chronic kidney disease). Recently, our group found that oral consumption of the ketone metabolite, 3- hydroxybutyrate (3-OHB), effectively stimulates insulin secretion and delays gastricemptying. We have also shown that 3-OHB inhibits gluconeogenesis 6, which may further contribute to glucose-lowering effects. Two other clinical studies have shown that serving 3- OHB before an oral glucose tolerance test (OGTT) lowered glucose excursions in healthy volunteers and persons with impaired glucose tolerance. There are no current data available about the effect of 3-OHB premeals in T2DM patients, but we have preliminary data from an ongoing trial showing that 30 g of 3-OHB served 40 min before a mixed meal test effectively lowers postprandial glucose levels (around 3 mM) in patients with T2DM. The optimal dose and timing of 3-OHB pre-meals is unknown but important before initiating long-term clinical trials. We hypothesize that pre-melas of 3-OHB will affect postprandialglucose excursions in a time-dependent matter and servings 30 minutes before an OGTT is Deleted: 4 optimal in order to lower postprandial glucose excursions. The aim of this study is therefore to i) investigate the dose/response relationship between 3-OHB servings of 0, 10, 20 and 40 grams 30 minutes before an OGTT and, ii) investigate the role of timing by serving 20 grams of 3-OHB at different timepoints ahead of an OGTT (0, 30 and 60 minutes). The primary endpoint is glucose trajectories following the OGTT. This study will give important insight into the optimal dose and timing for potential future clinical long-term studies in patients with metabolic diseases (i.e., T2DM, obesity) ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04477161 -
Effect of Ketone Esters in Parkinson's Disease
|
N/A | |
Active, not recruiting |
NCT05477368 -
Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes
|
N/A | |
Completed |
NCT04817176 -
MI-CBT Adherence Program for Lifestyle Interventions in Older Adults
|
Early Phase 1 | |
Completed |
NCT04565444 -
Ketones and Muscle Protein Synthesis
|
N/A | |
Not yet recruiting |
NCT06418074 -
Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity
|
N/A | |
Not yet recruiting |
NCT03954665 -
Ketone Supplementation and Exercise Performance
|
N/A | |
Active, not recruiting |
NCT06097754 -
Intermittent Exogenous Ketosis (IEK) at High Altitude
|
N/A | |
Terminated |
NCT03790436 -
Betaquik as an Adjunct to Dietary Management of Epilepsy in Adults on the Modified Atkins Diet
|
N/A | |
Completed |
NCT03299543 -
Comparison Between Breath Acetone and Blood Beta-Hydroxybutyrate
|
||
Recruiting |
NCT04004676 -
Ketone Supplementation, Glycogen Replenishment and Time Trial Performance Following Glycogen Lowering Exercise
|
N/A | |
Not yet recruiting |
NCT03659825 -
Ketone Esters for Optimization of Cognitive Performance in Hypoxia
|
N/A | |
Active, not recruiting |
NCT04156477 -
Markers of Appetite Regulation During Exogenous Ketosis
|
N/A | |
Completed |
NCT04130724 -
Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status
|
||
Recruiting |
NCT04594265 -
Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure
|
Phase 2 | |
Not yet recruiting |
NCT04576026 -
Exogenous Ketone Supplementation and Cognitive Function During Exercise
|
N/A | |
Completed |
NCT05558488 -
The Effect of a Meatless,Keto Restrictive Diet on Body Composition,Strength Capacity,Oxidative Stress,Immune Response
|
N/A | |
Recruiting |
NCT03564002 -
Metabolic Effects of Very Low Carbohydrate Ketogenic Diet in Subjects With Severe Obesity
|
||
Completed |
NCT04309214 -
Market Research - Acceptability Study for New MCT Fat Products
|
N/A | |
Completed |
NCT05588427 -
Effect of Ketone Ester Supplementation on Hypoxic Tolerance
|
N/A | |
Recruiting |
NCT05656339 -
Metabolic Effects of Whey Protein Supplementation After Fasting in Volunteers
|
N/A |