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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Dodecanoic acid; Behavioral: Positive emotion; Behavioral: neutral emotion; Dietary supplement: saline

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospitals Leuven, Campus Gasthuisberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: positive emotion and fatty acid; positive emotion induction combine with 2.g Dodecanoic acid intragastric infusion	Dietary supplement: Dodecanoic acid; The middle chain saturated fatty acid that can be widely found in daily food.; Other Names: Lauric acid; Behavioral: Positive emotion; Positive emotion induced by facial expressions and classic music.
Experimental: neutral emotion and fatty acid; neutral emotion induction combine with 2.g Dodecanoic acid intragastric infusion	Dietary supplement: Dodecanoic acid; The middle chain saturated fatty acid that can be widely found in daily food.; Other Names: Lauric acid; Behavioral: neutral emotion; Neutral emotion induced by facial expressions and classic music.
Experimental: positive emotion and saline; positive emotion induction combine with saline intragastric infusion	Behavioral: Positive emotion; Positive emotion induced by facial expressions and classic music.; Dietary supplement: saline; saline
Placebo Comparator: neutral emotion and saline; neutral emotion induction combine with saline intragastric infusion	Behavioral: neutral emotion; Neutral emotion induced by facial expressions and classic music.; Dietary supplement: saline; saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
time evolution of gut hormones from the beginning until the end of a study visit		-10min 10min 20min 30min 40min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evolution of heart rate variability		-20min 20min
hedonic food intake	amount of milkshake drunk	40min

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Lukas Van Oudenhove, Prof, Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

General Publications

• 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. doi: 10.1038/sj.ijo.0801083.
• 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.
• 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. Epub 2011 Jul 25.
• 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. doi: 10.1038/sj.ejcn.1601768.
• 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. doi: 10.1053/j.gastro.2006.10.026. No abstract available.
• 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. doi: 10.1002/hbm.20337.
• Zhao D, Boey L, Weltens N, Biesiekierski JR, Iven J, Depoortere I, Tack J, Van Oudenhove L. Influence of subliminal intragastric fatty acid infusion on subjective and physiological responses to positive emotion induction in healthy women: A randomized trial. Psychoneuroendocrinology. 2019 Oct;108:43-52. doi: 10.1016/j.psyneuen.2019.06.010. Epub 2019 Jun 13.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: November 28, 2016
• First Submitted That Met QC Criteria: November 30, 2016
• First Posted (Estimate): December 5, 2016

Study Record Updates

• Last Update Posted (Estimate): December 6, 2016
• Last Update Submitted That Met QC Criteria: December 5, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: S55863

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to ethical rules the individual participant data will be kept confidential.