Gastro-Intestinal DisorderMOODYFRUCTOSENCT05371067
Fructose Effect on Neuroinflammation and Feelings
A study testing Fructose respiratory test in people with Gastro-Intestinal Disorder, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gastro-Intestinal Disorder
- What is being tested?
- Fructose respiratory test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2021to 16 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Gastro-Intestinal Disorder
- Being tested
- Fructose respiratory test
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fructose respiratory testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Other | Not described Receives: Other: Fructose respiratory test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1
Secondary outcomes (4)
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
Measured: 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.
HAD score (Hospital Anxiety and Depression Scale) with a minimum score of 0 and a maximum of 42. 14 items.
Measured: 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.
Spielberger State Anxiety Questionnaire Score (STAI) with 20 items rated from 1(none) to 4 (a lot).
Measured: 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
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start8 Jun 2021
- Primary completion16 May 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastro-Intestinal DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chloé Melchior, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371067
- Sponsor's protocol ID
- 2020/0209/HP
- Acronym
- MOODYFRUCTOSE
- Status last verified
- Feb 2026
- First submitted
- 3 Jan 2022
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41418890
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fructose Effect on Neuroinflammation and Feelings: Direct Action on the Brain or Indirect by the Intestinal Microbiota?
- ClinicalTrials.gov ID
- NCT05371067
- Acronym / sponsor ID
- MOODYFRUCTOSE / 2020/0209/HP
- Conditions
- Gastro-Intestinal Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Other | Other: Fructose respiratory test |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy volunteers
- Aged 18 to 35
- Male sex
- BMI between 18.5 and 25
- Affiliation to a social security scheme
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fructose respiratory testHealthy 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. | Other | Healthy volunteers |
Primary outcome
Evaluate the chronic effect of fructose on anxiety in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.
Time frame: Day 1
Spielberger State Anxiety Questionnaire Score (STAI) with 20 items rated from 1(none) to 4 (a lot).
4 secondary outcomes
Evaluate the fructose consumption in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Results publication: PubMed 41418890Coursan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chloé Melchior principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fructose respiratory test in people with Gastro-Intestinal Disorder, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the chronic effect of fructose on anxiety in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05371067, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.