Skip to main content
OpenTrials
Completed

NCT Number: NCT05371067

Fructose Effect on Neuroinflammation and Feelings

Fructose is increasingly present in our food. The increase in its consumption is associated with the increase in the prevalence of several pathologies such as metabolic syndrome or hepatic steatosis. The effect of fructose consumption on brain health has been poorly studied. Studies in animal models show that diets enriched in fructose promote the development of emotional behavior disorders. Fructose malabsorption is also associated with changes in the microbiota that could also impact brain health. However, no human study to date has associated fructose malabsorption with changes in the gut microbiota and effects on brain health.

The objective of this study is to study the emotional behavior of a population of healthy volunteers according to the presence or not of fructose malabsorption. Patients with fructose malabsorption are susceptible to gut dysbiosis without necessarily consuming high amounts of fructose.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastro-Intestinal Disorder Digestive System Diseases

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CHU de ROUEN

Rouen, 76000, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers
  • Aged 18 to 35
  • Male sex
  • BMI between 18.5 and 25
  • Affiliation to a social security scheme
  • Adult patient having read and understood the information letter and signed the consent form

Exclusion criteria

  • Presence of irritable bowel syndrome, celiac disease
  • Presence of a psychiatric illness
  • Presence of a neurodegenerative disease
  • Presence of an eating disorder
  • Presence of chronic disease, including inflammatory disease
  • Presence of diabetes
  • Presence of an acute infectious disease
  • Presence of a surgical history of the digestive tract (excluding appendectomy)
  • Taking long-term treatment
  • Taking antibiotics within 6 months
  • Taking probiotics within 3 months
  • Typical diet low in lactose, FODMAP, gluten, vegetarian, vegan, vegan, chromonutrition .... in progress
  • Smoker
  • Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / under guardianship or guardianship
  • Simultaneous participation in another interventional clinical trial

Treatment and study plan

Fructose respiratory test

Other

Healthy volunteers will performed a fructose respiratory test in order to evaluate if they are or not fructose malabsorbing. The two population will be compared about their feelings and their micriobiote.

Primary outcomes

  1. Evaluate the chronic effect of fructose on anxiety in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.

    Time frame: Day 1

    Spielberger State Anxiety Questionnaire Score (STAI) with 20 items rated from 1(none) to 4 (a lot).

Secondary outcomes

  1. Evaluate the fructose consumption in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.

    Time frame: For 7 days before day 30

    Usual fructose consumption assessed by dietary log over 7 days

  2. Evaluate the chronic effect of fructose on depression in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.

    Time frame: Day 1

    HAD score (Hospital Anxiety and Depression Scale) with a minimum score of 0 and a maximum of 42. 14 items.

  3. Evaluate the chronic effect of fructose on low-grade intestinal inflammation in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.

    Time frame: up to 1 month

    Spielberger State Anxiety Questionnaire Score (STAI) with 20 items rated from 1(none) to 4 (a lot).

  4. Evaluate the chronic effect of fructose on microbiota's composition in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.

    Time frame: up to 1 month

    Amplicon sequencing of the V3-V4 area (region) of bacterial 16S rRNA in volunteer's faeces

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Fructose Effect on Neuroinflammation and Feelings: Direct Action on the Brain or Indirect by the Intestinal Microbiota?

Acronym: MOODYFRUCTOSE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 12, 2022
Registry last updated
May 18, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.