Fructose Effect on Neuroinflammation and Feelings

Gastro-Intestinal Disorder Clinical Trial

— MOODYFRUCTOSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05371067
• Other study ID #: 2020/0209/HP
• Status: Recruiting
• Phase: N/A
• Start date: June 8, 2021
• Est. completion date: August 8, 2022

Study information

• Verified date: January 2022
• Source: University Hospital, Rouen
• Contact: Chloé Melchior
• Phone: 00332 32 88 89 90
• Email: Chloe.Melchior[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: August 8, 2022
• Est. primary completion date: August 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastro-Intestinal Disorder
• Gastrointestinal Diseases
• Intestinal Diseases

Intervention

Other:
• Fructose respiratory test
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.

Locations

Country	Name	City	State
France	CHU de ROUEN	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the chronic effect of fructose on anxiety in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.	Spielberger State Anxiety Questionnaire Score (STAI)	At the inclusion visit (V1)
Secondary	Evaluate the fructose consumption in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.	Usual fructose consumption assessed by dietary log over 7 days	For 7 days before V2
Secondary	Evaluate the chronic effect of fructose on depression in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.	HAD score	At the inclusion visit (V1)
Secondary	Evaluate the chronic effect of fructose on low-grade intestinal inflammation in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.	Score STAI	up to 1 month
Secondary	Evaluate the chronic effect of fructose on microbiota's composition in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.	Amplicon sequencing of the V3-V4 area (region) of bacterial 16S rRNA in volunteer's faeces	up to 1 month