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Effect of Intragastric Administration of Fatty Acids on Generalized Reward Sensitivity

Primary Purpose

Healthy Volunteers

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
dodecanoic acid
saline
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy Volunteers

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Men, self-reporting as heterosexual
  • Age: Adults (+ 17yr)
  • 19 ≤ BMI ≤ 27

Exclusion Criteria:

  • Participants must be in good health, both mental and physical. People with one or more of the following self-reported items applicable, are excluded:

    1. History of or current presence of:

  • Psychiatric disorders (among others, anxiety disorders, somatoform disorders, eating disorders, depression, addiction-related disorders, and the like)
  • Abdominal / Thoracic Surgery (excl appendectomy or cholecystectomy)
  • Neurological, endocrine or gastrointestinal-related disorders
  • Other serious medical conditions.

    2. Present the presence of:

  • Pain Symptoms
  • Use of medication that affects the function of the gastrointestinal tract and / or the nervous system; psychotropic drugs or pain killers
  • A recent accident or an operation which one has not yet fully recovered.

If it is positive answer to any of these criteria, participation will not be possible. These criteria are questioned in advance so that participants do not get unnecessarily turn up.

Sites / Locations

  • University Hospitals Leuven, campus Gasthuisberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

fatty acid

saline

Arm Description

the nutrient that can be widely found in daily food.

saline

Outcomes

Primary Outcome Measures

progressive ratio task
Participants click the screens to get candies. The number of clicks will be used as a measurement of eating behavior.
estimation task
Participants rate the attractiveness of 20 rewarding food pictures, 20 female face pictures on a 1-7 point scale.

Secondary Outcome Measures

VAS
participants rate their appetite related pictures on 100-point scale

Full Information

First Posted
October 24, 2016
Last Updated
May 5, 2017
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT02984150
Brief Title
Effect of Intragastric Administration of Fatty Acids on Generalized Reward Sensitivity
Official Title
Effect of Intragastric Administration of Fatty Acids on Generalized Reward Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aim to investigate the influence of intragastrically infused fatty acid on the generalization of responses to reward within the food domain and between financial and sexual domains.
Detailed Description
Earlier research at the Faculty of Economics and Business (FEB) has demonstrated generalization of reward sensitivity after sensory stimulation in a different domain. As increased sensory stimulation in the sexual domain (Van den Bergh et al. 2008) or the power domain (Briers et al. 2007), the preference for immediate small financial reward increased deferred pay. Hongda, DeWitte & Warlop (2008) were able to neutralize this effect by domain-specific financial satiation. In this research, The investigators investigate the possible influence of (subliminal) intragastric administration of fatty acids in reward sensitivity in the power domain, and whether this effect generalizes to financial and sexual domain. Previous research at the Translational Research Center for Gastrointestinal Disorders (TARGID) showed that such administration can neutralize the effects of mood-priming (Van Oudenhove et al., 2011). This study aims to examine the implications of those findings in the motivational domain. 60 healthy heterosexual men come to the lab twice, once for the fatty acid condition, once for the control condition (counterbalanced, and randomly assigned to sequence condition). In each session the same dv's are measured (first three tasks counterbalanced, progressive ratio task always at the end). At the end of the second session, participants also compete a series of interindividual difference measures (scales). This research forms the start of a collaboration between TARGID and the Center for Research in Marketing and Consumer Science at KU Leuven Faculty of Business and Economics. The current paradigm is largely based on an earlier study by Prof. Dr. Lukas Van Oudenhove showing the effect of intragastric administration of an identical fatty acid solution tested for mood regulation (Van Oudenhove et al., 2011). The procedure performed in this study, which is placing a thin nasogastric tube is frequently used in the TARGID research and other research and is absolutely proven to be safe, with no mention of any adverse reactions during numerous previous studies. Similar studies by our research group had already been approved by the Medical Ethics Committee, and as always sees Prof. Tack ensure that the study conducted by researchers who have received adequate training and have acquired sufficient experience in this specific procedure before the start of the study. The procedure can be carried out in healthy volunteers in a perfectly safe manner.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fatty acid
Arm Type
Experimental
Arm Description
the nutrient that can be widely found in daily food.
Arm Title
saline
Arm Type
Sham Comparator
Arm Description
saline
Intervention Type
Dietary Supplement
Intervention Name(s)
dodecanoic acid
Other Intervention Name(s)
Lauric acid
Intervention Type
Dietary Supplement
Intervention Name(s)
saline
Primary Outcome Measure Information:
Title
progressive ratio task
Description
Participants click the screens to get candies. The number of clicks will be used as a measurement of eating behavior.
Time Frame
10min
Title
estimation task
Description
Participants rate the attractiveness of 20 rewarding food pictures, 20 female face pictures on a 1-7 point scale.
Time Frame
10min
Secondary Outcome Measure Information:
Title
VAS
Description
participants rate their appetite related pictures on 100-point scale
Time Frame
10min

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men, self-reporting as heterosexual Age: Adults (+ 17yr) 19 ≤ BMI ≤ 27 Exclusion Criteria: Participants must be in good health, both mental and physical. People with one or more of the following self-reported items applicable, are excluded: 1. History of or current presence of: Psychiatric disorders (among others, anxiety disorders, somatoform disorders, eating disorders, depression, addiction-related disorders, and the like) Abdominal / Thoracic Surgery (excl appendectomy or cholecystectomy) Neurological, endocrine or gastrointestinal-related disorders Other serious medical conditions. 2. Present the presence of: Pain Symptoms Use of medication that affects the function of the gastrointestinal tract and / or the nervous system; psychotropic drugs or pain killers A recent accident or an operation which one has not yet fully recovered. If it is positive answer to any of these criteria, participation will not be possible. These criteria are questioned in advance so that participants do not get unnecessarily turn up.
Facility Information:
Facility Name
University Hospitals Leuven, campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Briers, B., Pandelaere, M. & Warlop, L. (2007). Adding exchange to charity: A reference price explanation. Journal of Economic Psychology, 28, 15-30. doi: 10.1016/j.joep.2005.12.001.
Results Reference
background
PubMed Identifier
20080096
Citation
Lassman DJ, McKie S, Gregory LJ, Lal S, D'Amato M, Steele I, Varro A, Dockray GJ, Williams SC, Thompson DG. Defining the role of cholecystokinin in the lipid-induced human brain activation matrix. Gastroenterology. 2010 Apr;138(4):1514-24. doi: 10.1053/j.gastro.2009.12.060. Epub 2010 Jan 18.
Results Reference
background
Citation
Van den Bergh, B., Dewitte, S. & Warlop, L. (2008). Bikinis instigate generalized impatience in intertemporal choice. Journal of Consumer Behavior, 35, 85-97. doi: 10.1086/525505
Results Reference
background
PubMed Identifier
21785220
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. Epub 2011 Jul 25.
Results Reference
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Effect of Intragastric Administration of Fatty Acids on Generalized Reward Sensitivity

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