Status:
COMPLETED
Lidocaine and Food Intake
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Hunger
Eligibility:
MALE
18-50 years
Phase:
PHASE4
Brief 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 mea...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2018
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03227900
Start Date
July 19 2017
End Date
June 26 2018
Last Update
August 1 2018
Active Locations (1)
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1
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6229 HX