Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-22 @ 9:16 AM
Study NCT ID:
NCT06589856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Oral Lactate Affect Gut Hormone Secretion in a Dose-response Relationship?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized single-blinded, placebo-controlled crossover study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-06', 'studyFirstSubmitDate': '2024-09-06', 'studyFirstSubmitQcDate': '2024-09-06', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in mean insulin concentration', 'timeFrame': '60 minutes', 'description': 'Difference in mean insulin concentration 60 minutes after the intervention between CTR and LAC5, LAC10, and LAC20.'}], 'secondaryOutcomes': [{'measure': 'Difference in blood glucose', 'timeFrame': '0-180 minutes after the intervention'}, {'measure': 'Difference in GLP-1', 'timeFrame': '0-180 minutes after the intervention'}, {'measure': 'Difference in GIP', 'timeFrame': '0-180 minutes after the intervention'}, {'measure': 'Difference in LEAP2', 'timeFrame': '0-180 minutes after the intervention'}, {'measure': 'Difference in glucagon', 'timeFrame': '0-180 minutes after the intervention'}, {'measure': 'Difference in c-peptide', 'timeFrame': '0-180 minutes after the intervention'}, {'measure': 'Difference in gastric emptying rate', 'timeFrame': '0-180 minutes after the intervention', 'description': 'Acetaminophen test'}, {'measure': 'Difference in appetite sensation', 'timeFrame': '0-180 minutes', 'description': 'VAS (visual analoge scale)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'To investigate whether there is a linear dose-response relationship between oral lactate and its effects on gut hormone secretion, motility, and appetite.\n\nHypothesis Oral lactate administration affects gut hormone secretion, insulin levels, motility, appetite sensation and the amount of food intake in a linear dose-response relationship.', 'detailedDescription': 'The participants will meet up fasting at the Steno Diabetes Centre Aarhus Research Lab. Immediately after arrival, they will be placed in a bed. The four trial days will be completely alike, besides the interventions.\n\nThe participants will have one intravenous (iv.) access placed in the elbow on the four trial days for a continuous drawing of blood samples throughout the trial day.\n\nBefore drinking the intervention, baseline blood samples will be drawn. Immediately after drinking the intervention, the participants will take 1500 mg paracetamol to determine ventricular emptying rate through the acetaminophen test.\n\nAfter this, the participants can lay in their bed and watch TV, Ipad or work on their computer. Blood samples will be collected at 0, 10, 20, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes after the intervention. Appetite sensations will be measured by a visual analog scales (VAS). After 3 hours the trial day is finished, and the participants can go home.\n\nBefore and after each trial day the participants will collect a fecal sample.\n\nWe will use ANOVA and mixed model regression analyses for comparing the four groups.\n\nBased on a previous study we will need 11 individuals to detect a difference of 17,3 pmol/L in mean insulin concentrations at time 60 minutes, with a SD of 18,3 (α=0.05, β=0.80). To account for potential missing values, we will include a total of 12 participants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18-75 years\n* Written and oral consent\n* Healthy\n\nExclusion Criteria:\n\n* HbA1c \\> 39\n* Taking medicine\n* Any diseases\n* Allergy to paracetamol\n* Doesn't speak or understand Danish.\n* Special diets"}, 'identificationModule': {'nctId': 'NCT06589856', 'briefTitle': 'Does Oral Lactate Affect Gut Hormone Secretion in a Dose-response Relationship?', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Does Oral Lactate Affect Gut Hormone Secretion in a Dose-response Relationship?', 'orgStudyIdInfo': {'id': 'LAMETA-DOSE-RESPONSE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'CTR', 'interventionNames': ['Dietary Supplement: Placebo', 'Dietary Supplement: LAC5', 'Dietary Supplement: LAC10', 'Dietary Supplement: LAC20']}, {'type': 'EXPERIMENTAL', 'label': 'LAC5', 'interventionNames': ['Dietary Supplement: Placebo', 'Dietary Supplement: LAC5', 'Dietary Supplement: LAC10', 'Dietary Supplement: LAC20']}, {'type': 'EXPERIMENTAL', 'label': 'LAC10', 'interventionNames': ['Dietary Supplement: Placebo', 'Dietary Supplement: LAC5', 'Dietary Supplement: LAC10', 'Dietary Supplement: LAC20']}, {'type': 'EXPERIMENTAL', 'label': 'LAC20', 'interventionNames': ['Dietary Supplement: Placebo', 'Dietary Supplement: LAC5', 'Dietary Supplement: LAC10', 'Dietary Supplement: LAC20']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo (300 mL salt water, NaCl) = CTR', 'armGroupLabels': ['CTR', 'LAC10', 'LAC20', 'LAC5']}, {'name': 'LAC5', 'type': 'DIETARY_SUPPLEMENT', 'description': '5 g lactate (300 mL lactate drink = 5 g D/L-lactate bound to Na) = LAC5', 'armGroupLabels': ['CTR', 'LAC10', 'LAC20', 'LAC5']}, {'name': 'LAC10', 'type': 'DIETARY_SUPPLEMENT', 'description': '10 g lactate (300 mL lactate drink = 10 g D/L-lactate bound to Na) = LAC10', 'armGroupLabels': ['CTR', 'LAC10', 'LAC20', 'LAC5']}, {'name': 'LAC20', 'type': 'DIETARY_SUPPLEMENT', 'description': '20 g lactate (300 mL lactate drink = 20 g D/L-lactate bound to Na) = LAC20', 'armGroupLabels': ['CTR', 'LAC10', 'LAC20', 'LAC5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'state': 'Aarhus N', 'country': 'Denmark', 'facility': 'Steno Diabetes Center Aarhus, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'centralContacts': [{'name': 'Esben Søndergaard', 'role': 'CONTACT', 'email': 'esben.sondergaard@clin.au.dk', 'phone': '004528730943'}, {'name': 'Jens H Voigt', 'role': 'CONTACT', 'email': 'Jens.voigt@clin.au.dk', 'phone': '004526395294'}], 'overallOfficials': [{'name': 'Esben Sondergaard', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University, Steno Diabetes Center Aarhus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD student', 'investigatorFullName': 'Jens Hohwü Voigt', 'investigatorAffiliation': 'University of Aarhus'}}}}