MedDataX Logo

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

NCT ID: NCT02982616

Last Updated: 2016-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

positive emotion and fatty acid

positive emotion induction combine with 2.g Dodecanoic acid intragastric infusion

Group Type EXPERIMENTAL

Dodecanoic acid

Intervention Type DIETARY_SUPPLEMENT

The middle chain saturated fatty acid that can be widely found in daily food.

Positive emotion

Intervention Type BEHAVIORAL

Positive emotion induced by facial expressions and classic music.

neutral emotion and fatty acid

neutral emotion induction combine with 2.g Dodecanoic acid intragastric infusion

Group Type EXPERIMENTAL

Dodecanoic acid

Intervention Type DIETARY_SUPPLEMENT

The middle chain saturated fatty acid that can be widely found in daily food.

neutral emotion

Intervention Type BEHAVIORAL

Neutral emotion induced by facial expressions and classic music.

positive emotion and saline

positive emotion induction combine with saline intragastric infusion

Group Type EXPERIMENTAL

Positive emotion

Intervention Type BEHAVIORAL

Positive emotion induced by facial expressions and classic music.

saline

Intervention Type DIETARY_SUPPLEMENT

saline

neutral emotion and saline

neutral emotion induction combine with saline intragastric infusion

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DIETARY_SUPPLEMENT

saline

neutral emotion

Intervention Type BEHAVIORAL

Neutral emotion induced by facial expressions and classic music.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dodecanoic acid

The middle chain saturated fatty acid that can be widely found in daily food.

Intervention Type DIETARY_SUPPLEMENT

Positive emotion

Positive emotion induced by facial expressions and classic music.

Intervention Type BEHAVIORAL

saline

saline

Intervention Type DIETARY_SUPPLEMENT

neutral emotion

Neutral emotion induced by facial expressions and classic music.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lauric acid

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lukas Van Oudenhove

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lukas Van Oudenhove, Prof

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospitals Leuven, campus Gasthuisberg

Leuven, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21785220 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14749739 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21750565 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17188960 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17290372 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10702749 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31226660 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S55863

Identifier Type: -

Identifier Source: org_study_id