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Healthy VolunteersNCT02982616

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

A study testing Dodecanoic acid, Positive emotion and saline in people with Healthy Volunteers, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Dodecanoic acid, Positive emotion and saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteBelgium
Study dates
Aug 2015to 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 18 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • University Hospitals Leuven, campus Gasthuisberg

    Leuven, 3000

Other trials in Belgium

About this study

Official title: 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.

Read the 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.

Being tested
Dodecanoic acid, Positive emotion, saline, neutral emotion

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

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

  • Positive emotionBehavioural

    Positive emotion induced by facial expressions and classic music.

  • salineDietary supplement

    saline

  • neutral emotionBehavioural

    Neutral emotion induced by facial expressions and classic music.

Study groups in NCT02982616
Study groupRoleWhat they receive
positive emotion and fatty acidExperimentalpositive emotion induction combine with 2.g Dodecanoic acid intragastric infusion
Receives: Dietary Supplement: Dodecanoic acid; Behavioral: Positive emotion
neutral emotion and fatty acidExperimentalneutral emotion induction combine with 2.g Dodecanoic acid intragastric infusion
Receives: Dietary Supplement: Dodecanoic acid; Behavioral: neutral emotion
positive emotion and salineExperimentalpositive emotion induction combine with saline intragastric infusion
Receives: Behavioral: Positive emotion; Dietary Supplement: saline
neutral emotion and salinePlacebo comparatorneutral emotion induction combine with saline intragastric infusion
Receives: Dietary Supplement: saline; Behavioral: neutral emotion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. time evolution of VAS from the beginning until the end of a study visit

    visual analogue scale for appetite related sensations

    Measured: -10min 0min 10min 20min 30min 40min

  2. time evolution of gut hormones from the beginning until the end of a study visit

    Measured: -10min 10min 20min 30min 40min

Secondary outcomes (2)

  1. evolution of heart rate variability

    Measured: -20min 20min

  2. hedonic food intake

    amount of milkshake drunk

    Measured: 40min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2016 (estimated)
  2. Study startAug 2015
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

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
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02982616
Sponsor's protocol ID
S55863
Status last verified
Dec 2016
First submitted
28 Nov 2016
Last updated
6 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Due to ethical rules the individual participant data will be kept confidential.

Publications

  • 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

  • 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.

    PubMed 14749739

  • 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.

    PubMed 21750565

  • 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.

    PubMed 17188960

  • 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.

    PubMed 17290372

  • 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.

    PubMed 10702749

  • 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.

    PubMed 31226660

Questions about this trial

What is this clinical trial studying?

A study testing Dodecanoic acid, Positive emotion 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 1 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 6 Dec 2016. 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?

time evolution of VAS from the beginning until the end of a study visit (time frame: -10min 0min 10min 20min 30min 40min). 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 NCT02982616, which also lists 7 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 6 Dec 2016.

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