Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Insulin sensitivity expressed as an M-value
研究概览
简要总结
Recent research reveals intriguing results concerning the role of exogenous lactate and the ketone body 3-hydroxybutyrate (3-OHB) as therapeutic tools to combat obesity and related conditions. Thus, oral administration of lactate and 3-OHB have separately been shown to suppress appetite sensations and slow gastric emptying while administered orally. Both seem to inhibit lipolysis while oral 3-OHB administration have shown direct insulin sensitizing effects. Furthermore, both substrates can be used as fuel for the heart.
The goal of this placebo-controlled randomized crossover design is to test exogenous lactate and the ketone body 3-hydroxybutyrate (3-OHB) in healthy, non-diabetic, obese adults.
The main questions it aims to answer are if chronic administration of LaKe ester affect or improve the following endpoints:
- Insulin sensitivity
- Appetite sensations
- Gastric emptying
- Lipolysis
- Cardiac output
- Left Ventricular Ejection Fraction
- Global Longitudinal Strain and other echocardiographic measures listed below
Participants will ingest a combined lactate and ketone body ester (LaKe ester) or placebo twice a day for 28 days before experimental days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 30-60 years
- •BMI range 30-40
- •Glycated haemoglobin (HbA1c) < 48 mmol/mol
- •Otherwise 'healthy'
- •Written and oral consent
排除标准
- •Medication that affect energy or glucose metabolism, eg metformin, insulin or Glucagon-like peptide-1 receptor (GLP-1) agonists
- •Specific diets (eg practicing ketogenic diets)
- •Cardiac arrhythmias (eg atrial fibrillation)
- •Ongoing acute/chronic serious diseases (eg, anemia, chronic kidney or liver disease)
- •Inability to understand Danish or English
结局指标
主要结局
Insulin sensitivity expressed as an M-value
时间窗: Throughout the cross-over design, approximately 12 weeks
On all study days, a hyperinsulinemic-euglycemic clamp is used to determine insulin sensitivity: continuous infusion of insulin (1 milliunit · kg lean body mass-1 · min-1) for 2 hours. The blood glucose is clamped at 5 mmol/l.
次要结局
- Mitral plane velocities in the lateral mitral annulus (e' and s')(Throughout the cross-over design, approximately 12 weeks)
- Changes in blood concentrations of lactate(Throughout the cross-over design, approximately 12 weeks)
- Differences in lipolysis rate(Throughout the cross-over design, approximately 12 weeks)
- Tricuspid annular plane systolic excursion (TAPSE)(Throughout the cross-over design, approximately 12 weeks)
- Changes in blood concentrations of brain-derived neurotrophic factor (BDNF)(Throughout the cross-over design, approximately 12 weeks)
- Differences in body weight and composition(Throughout the cross-over design, approximately 12 weeks)
- Cardiac Output (CO)(Throughout the cross-over design, approximately 12 weeks)
- Global Longitudinal Strain (GLS)(Throughout the cross-over design, approximately 12 weeks)
- Changes in blood concentrations of free fatty acids(Throughout the cross-over design, approximately 12 weeks)
- Changes in blood concentrations of gastric inhibitory polypeptide (GIP)(Throughout the cross-over design, approximately 12 weeks)
- Changes in blood concentrations of glucagon(Throughout the cross-over design, approximately 12 weeks)
- Changes in blood concentrations of triglycerides(Throughout the cross-over design, approximately 12 weeks)
- Changes in blood concentrations of cholesterol(Throughout the cross-over design, approximately 12 weeks)
- Differences in gastric emptying rate(Throughout the cross-over design, approximately 12 weeks)
- Global work index (GWI)(Throughout the cross-over design, approximately 12 weeks)
- Changes in blood concentrations of glucose(Throughout the cross-over design, approximately 12 weeks)
- Changes in blood concentrations of insulin(Throughout the cross-over design, approximately 12 weeks)
- Changes in blood concentrations of C-peptide(Throughout the cross-over design, approximately 12 weeks)
- Fibrosis-4 (FIB-4)(Throughout the cross-over design, approximately 12 weeks)
- Left Ventricular Ejection Fraction (LVEF)(Throughout the cross-over design, approximately 12 weeks)
- Mitral inflow velocities (E and A)(Throughout the cross-over design, approximately 12 weeks)
- Changes in blood concentrations of 3-OHB(Throughout the cross-over design, approximately 12 weeks)
- Changes in plasma concentrations of growth/differentiation factor 15 (GDF-15)(Throughout the cross-over design, approximately 12 weeks)
- Mood, assessed by Major Depression Inventory score (MDI)(Throughout the cross-over design, approximately 12 weeks)
- Changes in blood concentrations of N-lactoyl-phenylalanine (Lac-Phe)(Throughout the cross-over design, approximately 12 weeks)
- Changes in blood concentrations of erythrocyte volume fraction (EVF)(Throughout the cross-over design, approximately 12 weeks)
- Changes in blood concentrations of Erythropoietin (EPO)(Throughout the cross-over design, approximately 12 weeks)
- Changes in blood concentrations of ghrelin(Throughout the cross-over design, approximately 12 weeks)
- Changes in blood concentrations of liver-expressed antimicrobial peptide 2 (LEAP-2)(Throughout the cross-over design, approximately 12 weeks)
- Changes in blood concentrations of inflammation markers(Throughout the cross-over design, approximately 12 weeks)
- Anxiety Symptom Scale questionnaire (ASS)(Throughout the cross-over design, approximately 12 weeks)
- Supplement tolerability(Throughout the cross-over design, approximately 12 weeks)
- Control of Eating Questionnaire (CoEQ)(Throughout the cross-over design, approximately 12 weeks)