Fructose Effect on Neuroinflammation and Feelings

NCT ID: NCT05371067

Last Updated: 2022-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-08
• Study Completion Date: 2022-08-08

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.

Conditions

Gastro-Intestinal Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Healthy volunteers

Group Type: OTHER

Fructose respiratory test

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chloé Melchior

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

CHU de ROUEN

Rouen, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Chloé Melchior

Role: CONTACT

Chloe.Melchior@chu-rouen.fr

00332 32 88 89 90

Facility Contacts

Nell Marty

Role: primary

nell.marty@chu-rouen.fr

003 2 32 88 82 65

Other Identifiers

2020/0209/HP

Identifier Type: -

Identifier Source: org_study_id