Lidocaine and Food Intake
Condition: Hunger
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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):

        1. To investigate the effect of intragastric infusion of lidocaine on satiety/satiation.

        2. To study the effect of intragastric infusion of lidocaine on gastrointestinal
           complaints.

      Design: Double blind randomized placebo-controlled cross-over trial in healthy male
      volunteers.

      Study population: 35 healthy human male volunteers, 18 - 50 years old. Main study
      parameters/endpoints: Difference in ad libitum meal intake (as measured during ad libitum
      chili con carne meal).

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: Visual Analogue Scales (VAS) scores for satiety feelings (e.g., satiety,
      fullness, hunger, prospective feeding, desire to eat, desire to snack) and gastrointestinal
      symptoms (burning, bloating, belching, cramps, colics, warm sensation, sensation of abdominal
      fullness, nausea and pain) will be measured using VAS (0 to 100 mm) anchored at the low end
      with the most negative or lowest intensity feelings (e.g., extremely unpleasant, not at all),
      and with opposing terms at the high end (e.g., extremely pleasant, very high, extreme).
      Volunteers will be asked to indicate on a line which place on the scale best reflects their
      feeling at that moment. The scoring forms will be collected immediately so that they cannot
      be used as a reference for later scorings.

      Catheter placement: the subjects will perceive mild discomfort during the placement of the
      catheter. Subjects can, at any time, come in contact with the investigator if any problems
      occur. All participants are healthy volunteers and we don't expect any health benefits or
      disadvantages.
    

Intervention name(s): Lidocaine; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Intragastric infusion of lidocain; Intragastric infusion of water for injections
Other intervention name(s): water for injections
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double blind randomized cross over trial
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science