Lidocaine and Food Intake

NCT03227900 | Completed Phase 4

• 1 other identifier: METC 163054
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hunger

Outcome Measures

Primary Outcomes (1)

• Difference in ad libitum meal intake after intragastric lidocain infusion compared to placebo

  The difference in ad libitum food intake (kcal) after intragastric infusion of lidocaine and placebo and active within a subject.

  Difference between Test day 1 and Test day 2 (minimal wash out of 7 days)

Secondary Outcomes (2)

• Difference in visual analogue scores for gastrointestinal complaints after intragastric lidocain infusion compared to placebo.

  15 minutes before the start of the infusion of placebo or lidocaine and after the start of the infusion every 15 minutes, until 90 minutes after start of infusion (8 times total).

• Difference in visual analogue scores for satiation after intragastric lidocain infusion compared to placebo.

  15 minutes before the start of the infusion of placebo or lidocaine and after the start of the infusion every 15 minutes, until 90 minutes after start of infusion (8 times total).

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

LIdocaine dissolved in water for injections

Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

Water for injections

Drug: Placebos

Interventions

Lidocaine DRUG

Intragastric infusion of lidocain

Lidocaine

Placebos DRUG

Intragastric infusion of water for injections

Also known as: water for injections

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Only males are eligible, because of the hormonal influence on food intake in females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Based on medical history and previous examination, no gastrointestinal complaints can be defined.
• BMI between 20 and 25 kg/m2
• Weight stable over at least the last 6 months (≤5% weight change)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6229 HX, Netherlands

Location

MeSH Terms

Interventions

Lidocaine; Water; Injections

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Ad Masclee, MD, PhD

  Maastricht University Medical Center (MUMC+)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Masking of participant and investigator
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind randomized cross over trial

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 24, 2017
• Study Start: July 19, 2017
• Primary Completion: June 26, 2018
• Study Completion: June 26, 2018
• Last Updated: August 1, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)