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Fructose Effect on Neuroinflammation and Feelings (MOODYFRUCTOSE)

Primary Purpose

Gastro-Intestinal Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Fructose respiratory test
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gastro-Intestinal Disorder

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de ROUENRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Healthy volunteers

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
January 3, 2022
Last Updated
May 6, 2022
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT05371067
Brief Title
Fructose Effect on Neuroinflammation and Feelings
Acronym
MOODYFRUCTOSE
Official Title
Fructose Effect on Neuroinflammation and Feelings: Direct Action on the Brain or Indirect by the Intestinal Microbiota?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
August 8, 2022 (Anticipated)
Study Completion Date
August 8, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-Intestinal Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chloé Melchior
Phone
00332 32 88 89 90
Email
Chloe.Melchior@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chloé Melchior
Organizational Affiliation
CHU de ROUEN
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de ROUEN
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nell Marty
Phone
003 2 32 88 82 65
Email
nell.marty@chu-rouen.fr

12. IPD Sharing Statement

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Fructose Effect on Neuroinflammation and Feelings

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