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MOODYFRUCTOSE: Fructose Effect on Neuroinflammation and Feelings

Sponsor
University Hospital, Rouen (Other)
Overall Status
Recruiting
CT.gov ID
NCT05371067
Collaborator
(none)
55
Enrollment
1
Location
1
Arm
14
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Fructose respiratory test
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
55 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Fructose Effect on Neuroinflammation and Feelings: Direct Action on the Brain or Indirect by the Intestinal Microbiota?
Actual Study Start Date :
Jun 8, 2021
Anticipated Primary Completion Date :
Aug 8, 2022
Anticipated Study Completion Date :
Aug 8, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Evaluate the chronic effect of fructose on anxiety in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption. [At the inclusion visit (V1)]

    Spielberger State Anxiety Questionnaire Score (STAI)

Secondary Outcome Measures

  1. Evaluate the fructose consumption in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption. [For 7 days before V2]

    Usual fructose consumption assessed by dietary log over 7 days

  2. Evaluate the chronic effect of fructose on depression in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption. [At the inclusion visit (V1)]

    HAD score

  3. 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]

    Score STAI

  4. 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]

    Amplicon sequencing of the V3-V4 area (region) of bacterial 16S rRNA in volunteer's faeces

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de ROUEN Rouen France 76000

Sponsors and Collaborators

  • University Hospital, Rouen

Investigators

  • Principal Investigator: Chloé Melchior, CHU de ROUEN

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT05371067
Other Study ID Numbers:
  • 2020/0209/HP
First Posted:
May 12, 2022
Last Update Posted:
May 12, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

Study Results

No Results Posted as of May 12, 2022