Influence of Intragastric Fatty Acid Infusion on Behavioral Responses to Positive Emotion Induction in Healthy Subjects

Healthy Volunteers Clinical Trial

Official title:

Influence of Intragastric Fatty Acid Infusion on Behavioral Responses to Positive Emotion Induction in Normal Weight Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982616
• Other study ID #: S55863
• Status: Completed
• Phase: N/A
• First received: November 28, 2016
• Last updated: December 5, 2016
• Start date: August 2015
• Est. completion date: June 2016

Study information

• Verified date: December 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test whether intragastrically infused fatty acid will interact with positive emotion induction and if this effect is mediated by gut hormones.

Description:

This study aims at the possible effect of subliminal intragastric administration of fatty acids on responses to positive emotion induction, based on our earlier findings that subjective administration of fatty acid decreases neural responses to negative mood induction (Van Oudenhove et al, J Clin Invest 2011). After screening for exclusion criteria and the participants sign the informed consent form, an intravenous catheter is placed in the forearm, and a naso-gastric tube inserted through the nose. Then the test subject is connected to the equipment in order to record the activity of the autonomic nervous system, via three electrocardiogram electrodes. By using the nasogastric tube we serve a fatty acid solution (Dodecanoic acid, "fatty acid" condition) or a physiological saline solution ( "control" condition) intragastrically. The intragastric administration of low doses of this food ingredient has already been used in several previous studies by our research group and has proven perfectly safe. A positive or neutral emotional state will be induced by the combination of looking at emotional facial expressions and listening to classical music pieces that were previously validated for this purpose; This combination of incentives has already been used in previous studies of our research group. Responses will be measured by means of validated self-report scales and measurements of the vagal tone. We also take blood samples on a regular basis by the intravenous catheter for determination of gastrointestinal hormones, given our hypothesis that this may explain the effect on emotions. After removal of the nasogastric tube, the influence of subliminal administration of fatty acids and emotional state on food intake measured by means of a validated and previously drink test used in which participants "ad libitum" to drink a chocolate milkshake while the emotion-induction by means of classical music pieces continue. Finally, the intravenous catheter is removed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• healthy women

• age > 18 and < 60.

• Body Mass Index (BMI) of 19-25 kg/m2 (no weight change of more than 5% of body weight in the past three months).

Exclusion Criteria:

• chronic medical illness affecting the gastrointestinal, endocrine, cardiovascular or nervous system (risk of) pregnancy history of upper gastrointestinal surgery history of behavioral, therapeutic or surgical treatment aiming at or leading to weight loss/gain psychiatric disorders, including (history of) depression or eating disorders alcohol abuse or dependence regular use of medication, except for oral contraception use of any drugs, including cannabis, during the past 6 months

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Dodecanoic acid
The middle chain saturated fatty acid that can be widely found in daily food.

Behavioral:
• Positive emotion
Positive emotion induced by facial expressions and classic music.

Dietary Supplement:
• saline
saline

Behavioral:
• neutral emotion
Neutral emotion induced by facial expressions and classic music.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven, campus Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (6)

Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48. — View Citation

Mayer EA, Naliboff BD, Craig AD. Neuroimaging of the brain-gut axis: from basic understanding to treatment of functional GI disorders. Gastroenterology. 2006 Dec;131(6):1925-42. Review. — View Citation

Mayer EA. Gut feelings: the emerging biology of gut-brain communication. Nat Rev Neurosci. 2011 Jul 13;12(8):453-66. doi: 10.1038/nrn3071. Review. — View Citation

Mitterschiffthaler MT, Fu CH, Dalton JA, Andrew CM, Williams SC. A functional MRI study of happy and sad affective states induced by classical music. Hum Brain Mapp. 2007 Nov;28(11):1150-62. — View Citation

Parker BA, Sturm K, MacIntosh CG, Feinle C, Horowitz M, Chapman IM. Relation between food intake and visual analogue scale ratings of appetite and other sensations in healthy older and young subjects. Eur J Clin Nutr. 2004 Feb;58(2):212-8. — View Citation

Van Oudenhove L, McKie S, Lassman D, Uddin B, Paine P, Coen S, Gregory L, Tack J, Aziz Q. Fatty acid-induced gut-brain signaling attenuates neural and behavioral effects of sad emotion in humans. J Clin Invest. 2011 Aug;121(8):3094-9. doi: 10.1172/JCI46380. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time evolution of VAS from the beginning until the end of a study visit	visual analogue scale for appetite related sensations	-10min 0min 10min 20min 30min 40min	No
Primary	time evolution of gut hormones from the beginning until the end of a study visit		-10min 10min 20min 30min 40min	No
Secondary	evolution of heart rate variability		-20min 20min	No
Secondary	hedonic food intake	amount of milkshake drunk	40min	No