Effect of the Motilin Receptor Agonist, Erythromycin, on Hunger and Food Intake; Study of Role of Cholinergic Pathways

NCT02633579 | Completed

• 1 other identifier: ErythromycinHungerFoodIntake
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, the investigators will evaluate if the food intake associated with the infusion of erythromycin is caused by the phase 3 contractions or by another yet unknown effect of erythromycin. To obtain this the investigators will use atropine, a muscarinic receptor antagonist, to inhibit the formation of contractions induced by a low dose of erythromycin

Conditions

Healthy

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Change in hunger ratings from time of administration over 6 hours

  visual analog scale

  6 hours after intervention, assessment every 5 minutes

Secondary Outcomes (1)

• Timing of food intake

  6 hours after intervention; up to 2 moments of food intake allowed

Study Arms (4)

Erythromycin lactobionate

ACTIVE COMPARATOR

40 mg erythromycin lactobionate was administered over a 20 min period in a volume of 100 ml sodium chloride 0.9 %

Drug: erythromycin lactobionate

Erythromycin lactobionate with atropine

ACTIVE COMPARATOR

40 mg erythromycin lactobionate was administered over a 20 min period in a volume of 100 ml sodium chloride 0.9 %; Atropine sulfate was given as an i.v. bolus (15 µg/kg) followed by a continuous infusion of 15 µg/kg/h over 30 min

Drug: Erythromycin with atropine

Atropine

PLACEBO COMPARATOR

Atropine sulfate was given as an i.v. bolus (15 µg/kg) followed by a continuous infusion of 15 µg/kg/h over 30 min. Infusion of saline as a placebo for erythromycin was administered over a 20 min period in a volume of 100 ml sodium chloride 0.9 %

Drug: Atropine

Placebo

PLACEBO COMPARATOR

Infusion of saline was administered over a 20 min period in a volume of 100 ml sodium chloride 0.9 %; also placebo for atropine was given as an i.v. bolus of saline followed by a continuous infusion over 30 min

Drug: Saline

Interventions

erythromycin lactobionate DRUG

intravenous administration of erythromycin

Also known as: Erythromycin

Erythromycin lactobionate

Atropine DRUG

intravenous administration of atropine

Atropine

Erythromycin with atropine DRUG

intravenous administration of erythromycin with saline

Erythromycin lactobionate with atropine

Saline DRUG

intravenous administration of saline

Also known as: Control

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male subjects aged 18 to 60
• Subject is capable and willing to give informed consent
• Female volunteers of child bearing potential must use oral, injected or implanted hormonal methods of contraception

You may not qualify if:

• Female volunteer is pregnant or breastfeeding
• Gastrointestinal diseases, major abdominal surgery
• Major psychiatric illnesses
• Volunteers that use drugs affecting the gastrointestinal tract or the central nervous system
• Allergy for macrolide antibiotics
• Allergy for atropine
• Severe heartburn
• Enlarged prostate
• Blockage of urinary tract
• Acute closed-angle glaucoma
• Myasthenia gravies
• Severe heart disease
• Thyrotoxicosis
• Fever
• Liver problems

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Related Publications (15)

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  PMID: 5353053 BACKGROUND

• Itoh Z. AI, Takeuchi S., Couch E. F., editor. Hunger contractions and motilin. 5th International Symposium on Gastrointestinal Motility; 1975; Herentals, Belgium.

  BACKGROUND

• Tack J, Deloose E, Ang D, Scarpellini E, Vanuytsel T, Van Oudenhove L, Depoortere I. Motilin-induced gastric contractions signal hunger in man. Gut. 2016 Feb;65(2):214-24. doi: 10.1136/gutjnl-2014-308472. Epub 2014 Dec 24.

  PMID: 25539673 BACKGROUND

• Scarpellini E. HN, D. Ang, P. Vanden Berghe, I. Depoortere, J. Tack. Role of upper gastrointestinal motility stimulation in the occurence of hunger peaks. Gastroenterology. 2009;136:A330

  BACKGROUND

• Janssens J, Vantrappen G, Peeters TL. The activity front of the migrating motor complex of the human stomach but not of the small intestine is motilin-dependent. Regul Pept. 1983 Aug;6(4):363-9. doi: 10.1016/0167-0115(83)90265-3.

  PMID: 6635258 BACKGROUND

• Tack J, Depoortere I, Bisschops R, Delporte C, Coulie B, Meulemans A, Janssens J, Peeters T. Influence of ghrelin on interdigestive gastrointestinal motility in humans. Gut. 2006 Mar;55(3):327-33. doi: 10.1136/gut.2004.060426. Epub 2005 Oct 10.

  PMID: 16216827 BACKGROUND

• Coulie B, Tack J, Peeters T, Janssens J. Involvement of two different pathways in the motor effects of erythromycin on the gastric antrum in humans. Gut. 1998 Sep;43(3):395-400. doi: 10.1136/gut.43.3.395.

  PMID: 9863486 BACKGROUND

• Bayer LM, Bauers CM, Kapp SR. Psychosocial aspects of nutritional support. Nurs Clin North Am. 1983 Mar;18(1):119-28.

  PMID: 6403929 BACKGROUND

• Patel KA, Schlundt DG. Impact of moods and social context on eating behavior. Appetite. 2001 Apr;36(2):111-8. doi: 10.1006/appe.2000.0385.

  PMID: 11237346 BACKGROUND

• van Strien T, Oosterveld P. The children's DEBQ for assessment of restrained, emotional, and external eating in 7- to 12-year-old children. Int J Eat Disord. 2008 Jan;41(1):72-81. doi: 10.1002/eat.20424.

  PMID: 17634965 BACKGROUND

• Soetens B, Braet C, Van Vlierberghe L, Roets A. Resisting temptation: effects of exposure to a forbidden food on eating behaviour. Appetite. 2008 Jul;51(1):202-5. doi: 10.1016/j.appet.2008.01.007. Epub 2008 Feb 7.

  PMID: 18342989 BACKGROUND

• Wilson MM, Thomas DR, Rubenstein LZ, Chibnall JT, Anderson S, Baxi A, Diebold MR, Morley JE. Appetite assessment: simple appetite questionnaire predicts weight loss in community-dwelling adults and nursing home residents. Am J Clin Nutr. 2005 Nov;82(5):1074-81. doi: 10.1093/ajcn/82.5.1074.

  PMID: 16280441 BACKGROUND

• Lowe MR, Butryn ML, Didie ER, Annunziato RA, Thomas JG, Crerand CE, Ochner CN, Coletta MC, Bellace D, Wallaert M, Halford J. The Power of Food Scale. A new measure of the psychological influence of the food environment. Appetite. 2009 Aug;53(1):114-8. doi: 10.1016/j.appet.2009.05.016. Epub 2009 Jun 12.

  PMID: 19500623 BACKGROUND

• Hjelland IE, Ofstad AP, Narvestad JK, Berstad A, Hausken T. Drink tests in functional dyspepsia: which drink is best? Scand J Gastroenterol. 2004 Oct;39(10):933-7. doi: 10.1080/00365520410003344.

  PMID: 15513330 BACKGROUND

• Deloose E, Vos R, Janssen P, Van den Bergh O, Van Oudenhove L, Depoortere I, Tack J. The motilin receptor agonist erythromycin stimulates hunger and food intake through a cholinergic pathway. Am J Clin Nutr. 2016 Mar;103(3):730-7. doi: 10.3945/ajcn.115.113456. Epub 2016 Jan 27.

  PMID: 26817505 DERIVED

MeSH Terms

Interventions

erythromycin lactobionate; Erythromycin; Atropine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: December 17, 2015
• Study Start: October 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 17, 2015

Record last verified: 2015-10