We hypothesize that intragastric infusion of lidocaine will result in a delay of postprandial satiation and hereby an increase in food intake at an ad libitum meal. Furthermore, we hypothesize that lidocaine infusion will not result in an increase…
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate the effect of intragastric infusion of lidocaine on ad libitum
food intake
Secondary outcome
To investigate the effect of intragastric infusion of lidocaine on
satiety/satiation.
To study the effect of intragastric infusion of lidocaine on gastrointestinal
complaints.
Background 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 (13). All infusions were done 30 minutes
before the start of the meal intake (meal consisted of mealworms). Except for
esophagus, in this setting the infusion was performed 15 minutes before the
start of the meal intake.
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 bodyweight.
Therefore, the current study aims to investigate the effect of intragastric
administration of lidocaine on food intake, satiety/satiation and
gastrointestinal complaints.
Study objective
We hypothesize that intragastric infusion of lidocaine will result in a delay
of postprandial satiation and hereby an increase in food intake at an ad
libitum meal. Furthermore, we hypothesize that lidocaine infusion will not
result in an increase in any gastrointestinal complaints.
Study design
Double blind randomized placebo-controlled cross-over trial
Intervention
Lidocaine infusion into the stomach
Study burden and risks
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.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Age
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)
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | 2016-001900-47 |
| CCMO | NL57719.068.16 |