The effect of lidocaine infusion on ad libitum food intake and satiety in healthy volunteers

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 35

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

•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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of intragastric infusion of lidocaine on ad <br>libitum food intake;Secondary Objective: 1.To investigate the effect of intragastric infusion of lidocaine on <br>satiety/satiation.<br>2.To study the effect of intragastric infusion of lidocaine on <br>gastrointestinal complaints.;Primary end point(s): food intake in kcal;Timepoint(s) of evaluation of this end point: after the ad libitum meal

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): satiety/satiation (VAS scores)<br>gastrointestinal symptoms (VAS scores);Timepoint(s) of evaluation of this end point: before during and after infusion of lidocaine and placebo

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