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Influence of Intragastric Fructose Infusion on Behavioural and Neural Responses to Negative Emotion Induction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02946983
Enrollment
15
Registered
2016-10-27
Start date
2015-09-30
Completion date
2016-06-30
Last updated
2016-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

The investigators will test whether a subliminal, intragastric dose of fructose is able to influence the emotional state at the behavioural and neural level, as has been previously shown for fatty acids. They will also examine the potential involvement of gut peptide release. Based on previous research using fatty acids, an attenuating effect of fructose compared to placebo on the induced negative emotional state is hypothesized at the self-report as well as the brain level.

Interventions

OTHERFructose

Intragastric administration of fructose (25g dissolved in 250ml distilled water)

OTHERControl

Intragastric administration of distilled water

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy volunteers (N=15) * Male and female * Age 18 - 60 * Body Mass Index (BMI) of 20 - 25 kg/m2 * Stable body weight for at least 3 months prior to the start of the study

Exclusion criteria

* Abdominal or thoracic surgery. Exception: appendectomy * Gastrointestinal, endocrine or neurological diseases. Exception: IBS if the participant will be recruited in the patient group * Cardiovascular, respiratory, renal or urinary diseases * Hypertension * Food or drug allergies * Anemia * Eating disorders * Psychotic disorders * Depressive disorders * Emotional and/or restraint eating * No medication on a regular basis, exception: oral contraception * No history of cannabis use or any other drug of abuse for at least 12 months prior to the study * Alcohol abuse (more than 21 units of alcohol for men, more than 14 units for woman per week) * Conditions that can interfere with functional magnetic resonance imaging (fMRI), e.g. cochlear implants, metal fragments or metal implants in the body, pacemaker, neural stimulator, … * Pregnant or breastfeeding women * Claustrophobia

Design outcomes

Primary

MeasureTime frameDescription
Functional brain imagesFrom the start of the study until the endpoint of the study, with a total duration of 50 minutesChanges in brain responses after administration of our test solution compared to baseline will be assessed via functional magnetic resonance imaging

Secondary

MeasureTime frameDescription
Hunger scoresevery 10 minutes since the scan starts until 40 minutes after the start of the scanThe hunger scores will be taken every 10 minutes since the scan starts via a 10 cm visual analogue scale.
Mood assessment via the Self Assessment Manikin questionnaireevery 10 minutes since the scan starts until 40 minutes after the start of the scanMood will be assessed every 10 minutes since the scan starts via the Self Assessment Manikin questionnaire
Gut hormone levelsevery 10 minutes since the scan starts until 40 minutes after the start of the scanPeripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure gut hormones (motilin, ghrelin, CCK, PYY, GLP-1) by radioimmuno-assay.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026