NCT07463495招募中不适用
The Metabolic Effects of Oral Tributyrin Administration in Overweight/Obese Individuals
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Postprandial glucose
研究概览
简要总结
The goal of this double-blinded randomized clinical cross-over trial is to investigate the metabolic and appetite regulating effects of oral tributyrin (a butyrate pro-drug) administration vs placebo.
The main questions it aims to answer are:
- Does tributyrin have glucose lowering properties in humans?
- Does tributyrin reduce appetite in humans?
A sample size calculation estimated a minimum of 10 participants. We expect to include 12 participants in this study. Tributyrin or placebo is ingested once or twice daily for 2x2 weeks, separated by a washout period of minimum 2 weeks. On trial day following each 2-week period we assess:
- Postprandial blood sugar levels
- Hunger sensations (questionnaire)
- Enteroendocrine hormone secretion (GLP-1, GIP, PYY, LEAP2, ghrelin)
- Cardiac function (echocardiography) - An exploratory study evaluating the hemodynamic effects assessed by echocardiography is anticipated to be published separately.
- Caloric intake (ad libitum meal test)
- Gastric emptying rate (acetaminophen test)
- Resting metabolic rate (indirect calorimetry).
While at home, subjects will wear a sleep monitoring device for three consecutive nights and deliver fecal samples for analysis of short-chain fatty acid content and microbiota composition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A body mass index (BMI) between 30-45 kg/m2
- •Older than 18 years of age
- •HbA1c < 48 mmol/mol
- •Hemoglobin within normal range (females: 7.3-9.5 mmol/L, males: 8.3-10.5 mmol/L)
- •Written and oral consent to participate
排除标准
- •Medications affecting glucose metabolism and/or appetite (e.g. insulin, metformin, GLP-1 analogues)
- •Special diet (HCLF, ketogenic diets, vegan/vegetarian)
- •Ongoing cancer or other acute/chronic serious diseases (determined by PI)
- •Inability to understand Danish or English
- •Abnormal blood samples at screening visit (determined by PI and co-investigators)
- •Deemed unsuitable to participate by the PI and co-investigators
研究组 & 干预措施
Control
Placebo Comparator
Oral ingestion of placebo
干预措施: Control (Dietary Supplement)
Oral tributyrin
Experimental
Oral ingestion of tributyrin
干预措施: tributyrin (Dietary Supplement)
结局指标
主要结局
Postprandial glucose
时间窗: During trial day, time 120-300 minutes
iAUC of plasma glucose after ingestion of mixed meal
次要结局
- Subjective appetite - appetite questionaire(0, 60, 120, 180, 240, 300 minutes)
- Butyrate(During trial day, time 0-300 minutes)
- Caloric intake(Time 300 minutes)
- Gastric emptying assessed by acetaminophen(From ingestion of mixed meal test with acetaminophen, time 120-240 minutes)
- GLP-1(During trial day, time 0-300 minutes)
- GIP(During trial day, time 0-300 minutes)
- LEAP2(During trial day, time 0-300 minutes)
- PYY(During trial day, time 0-300 minutes)
- Ghrelin(During trial day, time 0-300 minutes)
- Insulin(During trial day, time 0-300 minutes)
- C-peptide(During trial day, time 0-300 minutes)
- Glucagon(During trial day, time 0-300 minutes)
- Cardiac function(Time 0 and 90 minutes)
- β-hydroxybutyrate(During trial day, time 0-300 minutes)
- Lactate(During trial day, time 0-300 minutes)
- C-reactive protein (CRP)(On trial day, time 0 minutes)
- Tumor Necrosis Factor ⍺ (TNF-⍺)(On trial day, time 0 minutes)
- Interleukin 6 (IL-6)(On trial day, time 0 minutes)
- Interleukin 10 (IL-10)(On trial day, time 0 minutes)
- Lipopolysaccharide Binding Protein (LPB)(On trial day, time 0 minutes)
- Cortisol(On trial day, time 0 minutes)
- Triglyceride(During trial day, time 0-300 minutes)
- FFA(During trial day, time 0-300 minutes)
- Energy expenditure(After 60 and 150 minutes approximately)
- Sleep(Three nights at the end of the 2 week period at home)
- Fecal butyrate(Day 0, 7, 14 during the 2 week period)
- Microbiome composition(Day 0, 7, 14 during the 2 week period)
研究者
研究点 (1)
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