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

October 26, 2016 updated by: Universitaire Ziekenhuizen KU Leuven
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fructose - Neutral emotion condition
Intragastric infusion of fructose with neutral emotion induction
Other: Fructose
Intragastric administration of fructose (25g dissolved in 250ml distilled water)
Active Comparator: Fructose - Sad emotion condition
Intragastric infusion of fructose with sad emotion induction
Other: Fructose
Intragastric administration of fructose (25g dissolved in 250ml distilled water)
Placebo Comparator: Placebo - Neutral emotion condition
Intragastric infusion of distilled water with neutral emotion induction
Other: Control
Intragastric administration of distilled water
Placebo Comparator: Placebo - Sad emotion condition
Intragastric infusion of distilled water with sad emotion induction
Other: Control
Intragastric administration of distilled water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional brain images
Time Frame: 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
From the start of the study until the endpoint of the study, with a total duration of 50 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hunger scores
Time Frame: 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.
every 10 minutes since the scan starts until 40 minutes after the start of the scan
Mood assessment via the Self Assessment Manikin questionnaire
Time Frame: 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
every 10 minutes since the scan starts until 40 minutes after the start of the scan
Gut hormone levels
Time Frame: 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.
every 10 minutes since the scan starts until 40 minutes after the start of the scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Jan Tack, Prof, University of Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

October 26, 2016

First Posted (Estimate)

October 27, 2016

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • S57996

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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