Clinical trial NCT05371067: Fructose Effect on Neuroinflammation and Feelings
Official title: Fructose Effect on Neuroinflammation and Feelings: Direct Action on the Brain or Indirect by the Intestinal Microbiota?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastro-Intestinal Disorder
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 55
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a monocentric, prospective, non-randomized, comparative assay in which volontarees are enrolled in order to study the fructose effects on intestinal microbiote and their consequencies on the emotions and the neuroinflammation.
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the chronic effect of fructose on anxiety in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.
timeFrame: At the inclusion visit (V1)
Secondary outcomes:
measure: Evaluate the fructose consumption in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.
timeFrame: For 7 days before V2
measure: Evaluate the chronic effect of fructose on depression in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.
timeFrame: At the inclusion visit (V1)
measure: Evaluate the chronic effect of fructose on low-grade intestinal inflammation in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.
timeFrame: up to 1 month
measure: Evaluate the chronic effect of fructose on microbiota's composition in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU de ROUEN
Study officials:
affiliation: University Hospital, Rouen
name: Chloé Melchior
role: PRINCIPAL_INVESTIGATOR
References: