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

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946983
• Other study ID #: S57996
• Status: Completed
• Phase: N/A
• First received: May 12, 2016
• Last updated: October 26, 2016
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: May 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Fructose
Intragastric administration of fructose (25g dissolved in 250ml distilled water)
• Control
Intragastric administration of distilled water

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional brain images	Changes in brain responses after administration of our test solution compared to baseline will be assessed via functional magnetic resonance imaging	From the start of the study until the endpoint of the study, with a total duration of 50 minutes	No
Secondary	Hunger scores	The hunger scores will be taken every 10 minutes since the scan starts via a 10 cm visual analogue scale.	every 10 minutes since the scan starts until 40 minutes after the start of the scan	No
Secondary	Mood assessment via the Self Assessment Manikin questionnaire	Mood will be assessed every 10 minutes since the scan starts via the Self Assessment Manikin questionnaire	every 10 minutes since the scan starts until 40 minutes after the start of the scan	No
Secondary	Gut hormone levels	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.	every 10 minutes since the scan starts until 40 minutes after the start of the scan	No