Influence of Intragastric Fatty Acid Infusion on Behavioral Responses to Positive Emotion Induction in Healthy Subjects
1 other identifier
interventional
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy-volunteers
Started Aug 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 28, 2016
CompletedFirst Posted
Study publicly available on registry
December 5, 2016
CompletedDecember 6, 2016
December 1, 2016
10 months
November 28, 2016
December 5, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
evolution of heart rate variability
-20min 20min
hedonic food intake
40min
Study Arms (4)
positive emotion and fatty acid
EXPERIMENTALpositive emotion induction combine with 2.g Dodecanoic acid intragastric infusion
neutral emotion and fatty acid
EXPERIMENTALneutral emotion induction combine with 2.g Dodecanoic acid intragastric infusion
positive emotion and saline
EXPERIMENTALpositive emotion induction combine with saline intragastric infusion
neutral emotion and saline
PLACEBO COMPARATORneutral emotion induction combine with saline intragastric infusion
Interventions
The middle chain saturated fatty acid that can be widely found in daily food.
Positive emotion induced by facial expressions and classic music.
Neutral emotion induced by facial expressions and classic music.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Leuven, campus Gasthuisberg
Leuven, 3000, Belgium
Related Publications (7)
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.
PMID: 21785220BACKGROUNDParker 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.
PMID: 14749739BACKGROUNDMayer EA. Gut feelings: the emerging biology of gut-brain communication. Nat Rev Neurosci. 2011 Jul 13;12(8):453-66. doi: 10.1038/nrn3071.
PMID: 21750565BACKGROUNDMayer 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.
PMID: 17188960BACKGROUNDMitterschiffthaler 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.
PMID: 17290372BACKGROUNDFlint 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.
PMID: 10702749BACKGROUNDZhao 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.
PMID: 31226660DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lukas Van Oudenhove, Prof
Universitaire Ziekenhuizen KU Leuven
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 28, 2016
First Posted
December 5, 2016
Study Start
August 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
December 6, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share
Due to ethical rules the individual participant data will be kept confidential.