The Effect of lidocaïne Infusion on ad Libitum Food Intake and Satiety in Healthy Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Difference in ad libitum meal intake after intragastric lidocain infusion compared to placebo
研究概览
简要总结
World's population over 60 years old is increasing rapidly. It is expected that in 2050 elderly population will be 22% of the total population, representing around 2 billion people. This situation means a rising in the incidence of elderly-related diseases, and thereby the need for long-term care. Reduction in body fat and weight are a common problem among the institutionalized elderly. Some factors that contribute to the anorexia of aging are decreased perception of hunger and increased satiation. This represents an increased risk of developing cachexia even during minor illnesses. The potentially severe consequences of anorexia of aging a greater understanding of the underlying mechanism of these changes is highly important. Intraesophageal and intragastric infusion of 20mg/kg lidocaine results in an increase in food intake in Wistar rats. All infusions were done 30 minutes before the start of the meal intake (meal consisted of mealworms). It may be possible to decrease satiation, increase hunger, and hence food intake in elderly individuals through gastric infusion of the anesthetics lidocaine or benzocaine. In the future this study could potentially contribute to improve food intake in elderly vulnerable of losing body weight. Therefore, the current study aims to investigate the effect of intragastric administration of lidocaine on food intake, satiety/satiation and gastrointestinal complaints.
详细描述
Aim: To determine the effect of intragastric infusion of lidocaine on satiation, gastrointestinal complaints and food intake.
Hypothesis: We hypothesize that intragastric administration of lidocaine will result in a delay of postprandial satiation and hereby will result in an increase in food intake. Furthermore, lidocaine infusion will not result in an increase in any gastrointestinal complaints.
Primary objective: To investigate the effect of intragastric infusion of lidocaine on ad libitum food intake.
Secondary Objective(s):
- To investigate the effect of intragastric infusion of lidocaine on satiety/satiation.
- To study the effect of intragastric infusion of lidocaine on gastrointestinal complaints.
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)
盲法说明
Masking of participant and investigator
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Based on medical history and previous examination, no gastrointestinal complaints can be defined.
- •Age between 18 and 50 years. Several studies (see introduction) showed a difference in response to a meal between young and elderly people. Inclusion of elderly could interfere with the outcome of this study. Goal of this study is to investigate whether a difference in food intake can be found after intragastric infusion of a local anaesthetic. For this proof of concept study we therefore choose to include healthy male volunteers with a maximum age of 50 years.
- •BMI between 20 and 25 kg/m2
- •Weight stable over at least the last 6 months (≤5% weight change)
排除标准
- •Females, because of their hormonal cycle and the possible influence of these hormones on eating behaviour.
- •History of severe cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, haematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
- •Use of amiodaron, because of the cardiotoxicity (in combination with lidocaine).
- •Use of beta blockers, cimetidine and norepinephrine (synergetic effect on the action of Lidocaine).
- •Other use of medication, which could interfere with the outcome of the study. This will be decided by the principal investigator.
- •Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 90 days prior to the study
- •Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
- •Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic)
- •Excessive alcohol consumption (>20 alcoholic consumptions per week)
- •Self-admitted HIV-positive state
- •Any food allergy
- •Not able to eat a chili con carne meal.
研究组 & 干预措施
Lidocaine
LIdocaine dissolved in water for injections
干预措施: Lidocaine (Drug)
Placebo
Water for injections
干预措施: Placebos (Drug)
结局指标
主要结局
Difference in ad libitum meal intake after intragastric lidocain infusion compared to placebo
时间窗: Difference between Test day 1 and Test day 2 (minimal wash out of 7 days)
The difference in ad libitum food intake (kcal) after intragastric infusion of lidocaine and placebo and active within a subject.
次要结局
- Difference in visual analogue scores for satiation after intragastric lidocain infusion compared to placebo.(15 minutes before the start of the infusion of placebo or lidocaine and after the start of the infusion every 15 minutes, until 90 minutes after start of infusion (8 times total).)
- Difference in visual analogue scores for gastrointestinal complaints after intragastric lidocain infusion compared to placebo.(15 minutes before the start of the infusion of placebo or lidocaine and after the start of the infusion every 15 minutes, until 90 minutes after start of infusion (8 times total).)