Fructose Effect on Neuroinflammation and Feelings (MOODYFRUCTOSE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastro-Intestinal Disorder
• Intervention / Treatment: Other: Fructose respiratory test

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chloé Melchior; Phone Number: 00332 32 88 89 90; Email: Chloe.Melchior@chu-rouen.fr

Study Locations

• France
  • Rouen, France, 76000
    • Recruiting
    • CHU de Rouen
    • Contact: Nell Marty; Phone Number: 003 2 32 88 82 65; Email: nell.marty@chu-rouen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy volunteers	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Chloé Melchior, CHU de Rouen

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2021
• Primary Completion (Anticipated): August 8, 2022
• Study Completion (Anticipated): August 8, 2022

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases
• Other Study ID Numbers: 2020/0209/HP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No