Fructose Effect on Neuroinflammation and Feelings

NCT05371067 | Completed

• 1 other identifier: 2020/0209/HP
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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) with 20 items rated from 1(none) to 4 (a lot).

  Day 1

Secondary Outcomes (4)

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

  For 7 days before day 30

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

  Day 1

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

  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.

  up to 1 month

Study Arms (1)

Healthy volunteers

OTHER

Other: Fructose respiratory test

Interventions

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.

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

CHU de ROUEN

Rouen, Rouen, 76000, France

Location

Related Publications (1)

• Coursan A, Polve D, Leroi AM, Monnoye M, Roussin L, Benatar C, Tavolacci MP, Quillard Muraine M, Maccarone M, Guerin O, Houivet E, Guerin C, Brunel V, Bellenger J, Pais de Barros JP, Gourcerol G, Naudon L, Laye S, Madore C, Fioramonti X, Melchior C, Douard V. Fructose malabsorption induces dysbiosis and increases anxiety in male human and animal models. Brain Behav Immun. 2026 Mar;133:106221. doi: 10.1016/j.bbi.2025.106221. Epub 2025 Dec 17.

  PMID: 41418890 RESULT

MeSH Terms

Conditions

Digestive System Diseases

Study Officials

• Chloé Melchior

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: May 12, 2022
• Study Start: June 8, 2021
• Primary Completion: May 16, 2022
• Study Completion: May 16, 2022
• Last Updated: May 18, 2026

Record last verified: 2026-02

Locations

FR (1)