food intake and satiety
Conditions
Interventions
Product Name: Lidocaine
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: LIDOCAINE HYDROCHLORIDE
Other descriptive name: 2-(diethylamino)-N-(2,6-dimethylphenyl)acetamide
hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Infusion
Route of administration of the placebo: Gastric use
Sponsors
Maastricht University Medical Centre +
Eligibility
Sex/Gender
Male
Inclusion 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. This study will include healthy male subjects. • BMI between 20 and 25 kg/m2) • Weight stable over at least the last 6 months (=5% weight change) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of intragastric infusion of lidocaine on ad libitum food intake;Secondary Objective: 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.;Primary end point(s): food intake in kcal;Timepoint(s) of evaluation of this end point: after the ad libitum meal | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): satiety/satiation (VAS scores) gastrointestinal symptoms (VAS scores);Timepoint(s) of evaluation of this end point: before during and after infusion of lidocaine and placebo | — |
Countries
Netherlands
Contacts
Public ContactAnnick Alleleyn
Maastricht University Medical Centre +
Outcome results
None listed