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

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: Fructose; Other: Control

• Registration Number: NCT02946983
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Status Verified: 2016-05
• Study First Submitted: 2016-05-12
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted QC: 2016-10-26
• Last Update Submitted: 2016-10-26
• Study First Posted: 2016-10-27
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fructose - Sad emotion condition	Fructose	Intragastric infusion of fructose with sad emotion induction
Placebo - Sad emotion condition	Control	Intragastric infusion of distilled water with sad emotion induction
Placebo - Neutral emotion condition	Control	Intragastric infusion of distilled water with neutral emotion induction
Fructose - Neutral emotion condition	Fructose	Intragastric infusion of fructose with neutral emotion induction

Primary Outcome Measures

Name	Time	Method
Functional brain images	From the start of the study until the endpoint of the study, with a total duration of 50 minutes	Changes in brain responses after administration of our test solution compared to baseline will be assessed via functional magnetic resonance imaging

Secondary Outcome Measures

Name	Time	Method
Hunger scores	every 10 minutes since the scan starts until 40 minutes after the start of the scan	The 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 questionnaire	every 10 minutes since the scan starts until 40 minutes after the start of the scan	Mood will be assessed every 10 minutes since the scan starts via the Self Assessment Manikin questionnaire
Gut hormone levels	every 10 minutes since the scan starts until 40 minutes after the start of the scan	Peripheral 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.