Lidocaine and Food Intake

• Status: Completed
• Trial end date: 2018-06-26
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Maastricht University Medical Center
• Treatments: Lidocaine

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

• Smoking

• Self-admitted HIV-positive state

• Any food allergy

• Not able to eat a chili con carne meal.