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OpenTrials
Completed

NCT Number: NCT02946983

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fructose

Other

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

Control

Other

Intragastric administration of distilled water

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 27, 2016
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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