Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT05371067
Status:
UNKNOWN
Last Update Posted:
2022-05-12
First Post:
2022-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fructose Effect on Neuroinflammation and Feelings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-08-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-06', 'studyFirstSubmitDate': '2022-01-03', 'studyFirstSubmitQcDate': '2022-05-06', 'lastUpdatePostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the chronic effect of fructose on anxiety in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.', 'timeFrame': 'At the inclusion visit (V1)', 'description': 'Spielberger State Anxiety Questionnaire Score (STAI)'}], 'secondaryOutcomes': [{'measure': 'Evaluate the fructose consumption in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.', 'timeFrame': 'For 7 days before V2', 'description': 'Usual fructose consumption assessed by dietary log over 7 days'}, {'measure': 'Evaluate the chronic effect of fructose on depression in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.', 'timeFrame': 'At the inclusion visit (V1)', 'description': 'HAD score'}, {'measure': 'Evaluate the chronic effect of fructose on low-grade intestinal inflammation in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.', 'timeFrame': 'up to 1 month', 'description': 'Score STAI'}, {'measure': "Evaluate the chronic effect of fructose on microbiota's composition in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.", 'timeFrame': 'up to 1 month', 'description': "Amplicon sequencing of the V3-V4 area (region) of bacterial 16S rRNA in volunteer's faeces"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastro-Intestinal Disorder']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n* Aged 18 to 35\n* Male sex\n* BMI between 18.5 and 25\n* Affiliation to a social security scheme\n* Adult patient having read and understood the information letter and signed the consent form\n\nExclusion Criteria:\n\n* Presence of irritable bowel syndrome, celiac disease\n* Presence of a psychiatric illness\n* Presence of a neurodegenerative disease\n* Presence of an eating disorder\n* Presence of chronic disease, including inflammatory disease\n* Presence of diabetes\n* Presence of an acute infectious disease\n* Presence of a surgical history of the digestive tract (excluding appendectomy)\n* Taking long-term treatment\n* Taking antibiotics within 6 months\n* Taking probiotics within 3 months\n* Typical diet low in lactose, FODMAP, gluten, vegetarian, vegan, vegan, chromonutrition .... in progress\n* Smoker\n* Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / under guardianship or guardianship\n* Simultaneous participation in another interventional clinical trial'}, 'identificationModule': {'nctId': 'NCT05371067', 'acronym': 'MOODYFRUCTOSE', 'briefTitle': 'Fructose Effect on Neuroinflammation and Feelings', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Fructose Effect on Neuroinflammation and Feelings: Direct Action on the Brain or Indirect by the Intestinal Microbiota?', 'orgStudyIdInfo': {'id': '2020/0209/HP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy volunteers', 'interventionNames': ['Other: Fructose respiratory test']}], 'interventions': [{'name': 'Fructose respiratory test', 'type': 'OTHER', '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.', 'armGroupLabels': ['Healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76000', 'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nell Marty', 'role': 'CONTACT', 'email': 'nell.marty@chu-rouen.fr', 'phone': '003 2 32 88 82 65'}], 'facility': 'CHU de ROUEN', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'centralContacts': [{'name': 'Chloé Melchior', 'role': 'CONTACT', 'email': 'Chloe.Melchior@chu-rouen.fr', 'phone': '00332 32 88 89 90'}], 'overallOfficials': [{'name': 'Chloé Melchior', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Rouen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}