Healthy VolunteersNCT02984150
Effect of Intragastric Administration of Fatty Acids on Generalized Reward Sensitivity
A study testing dodecanoic acid and saline in people with Healthy Volunteers, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- dodecanoic acid and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Men, self-reporting as heterosexual
- Age: Adults (+ 17yr)
- 19 ≤ BMI ≤ 27
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- dodecanoic acid, saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dodecanoic acidDietary supplement
Also called Lauric acid
salineDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| fatty acid | Experimental | the nutrient that can be widely found in daily food. Receives: Dietary Supplement: dodecanoic acid |
| saline | Sham comparator | saline Receives: Dietary Supplement: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
progressive ratio task
Participants click the screens to get candies. The number of clicks will be used as a measurement of eating behavior.
Measured: 10min
estimation task
Participants rate the attractiveness of 20 rewarding food pictures, 20 female face pictures on a 1-7 point scale.
Measured: 10min
Secondary outcomes (1)
VAS
participants rate their appetite related pictures on 100-point scale
Measured: 10min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startNov 2014
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukas Van Oudenhove, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984150
- Sponsor's protocol ID
- S55265
- Status last verified
- May 2017
- First submitted
- 24 Oct 2016
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 20080096Van 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
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.
PubMed 21785220
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intragastric Administration of Fatty Acids on Generalized Reward Sensitivity
- ClinicalTrials.gov ID
- NCT02984150
- Acronym / sponsor ID
- S55265
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fatty acid | Experimental | Dietary Supplement: dodecanoic acidthe nutrient that can be widely found in daily food. |
| saline | Sham comparator | Dietary Supplement: salinesaline |
Who may qualify
- Ages
- 17 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Men, self-reporting as heterosexual
- Age: Adults (+ 17yr)
- 19 ≤ BMI ≤ 27
Key exclusion criteria (11 listed)
- Participants must be in good health, both mental and physical. People with one or more of the following self-reported items applicable, are excluded:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dodecanoic acidAlso: Lauric acid | Dietary supplement | fatty acid |
| saline | Dietary supplement | saline |
Primary outcome
progressive ratio task
Time frame: 10min
Participants click the screens to get candies. The number of clicks will be used as a measurement of eating behavior.
estimation task
Time frame: 10min
Participants rate the attractiveness of 20 rewarding food pictures, 20 female face pictures on a 1-7 point scale.
1 secondary outcome
VAS
Time frame: 10min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- BackgroundBriers, 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.
- Background: PubMed 20080096Lassman 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.
- BackgroundVan 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
- Background: PubMed 21785220Van 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.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dodecanoic acid and saline in people with Healthy Volunteers, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progressive ratio task (time frame: 10min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02984150, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.