Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-30 @ 2:03 PM
Study NCT ID:
NCT05469503
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2022-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058246', 'term': 'Prehypertension'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 410}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2022-07-18', 'studyFirstSubmitQcDate': '2022-07-18', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic Blood Pressure at V4', 'timeFrame': 'V4 (12 weeks of intervention)', 'description': 'Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo'}], 'secondaryOutcomes': [{'measure': 'Evolution of Systolic Blood Pressure', 'timeFrame': 'V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks) and V5 (4 weeks after the stop of intervention)', 'description': 'Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo'}, {'measure': 'Evolution of Diastolic Blood Pressure', 'timeFrame': 'V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)', 'description': 'Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo'}, {'measure': 'Evolution of the fasting blood glycemia', 'timeFrame': 'V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)', 'description': 'Glycemia (in mg/dL), TOTUM-854 vs placebo'}, {'measure': 'Evolution of the fasting blood concentration of triglycerides', 'timeFrame': 'V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)', 'description': 'Triglycerides (in g/L), TOTUM-854 vs placebo'}, {'measure': 'Evolution of the fasting blood concentration of total cholesterol', 'timeFrame': 'V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)', 'description': 'Total cholesterol (in g/L), TOTUM-854 vs placebo'}, {'measure': 'Evolution of the fasting blood concentration of HDL cholesterol', 'timeFrame': 'V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)', 'description': 'HDL cholesterol (in g/L), TOTUM-854 vs placebo'}, {'measure': 'Evolution of the fasting blood concentration of non-HDL cholesterol', 'timeFrame': 'V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)', 'description': 'non-HDL cholesterol (in g/L), TOTUM-854 vs placebo'}, {'measure': 'Evolution of the fasting blood concentration of LDL cholesterol (Friedewald method)', 'timeFrame': 'V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)', 'description': 'LDL cholesterol (in g/L, Friedewald method), TOTUM-854 vs placebo'}, {'measure': 'Evolution of the fasting blood hsCRP concentration', 'timeFrame': 'V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)', 'description': 'hsCRP (in mg/L), TOTUM-854 vs placebo'}, {'measure': 'Evolution of the body weight', 'timeFrame': 'V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)', 'description': 'Body weight (in kg), TOTUM-854 vs placebo'}, {'measure': 'Evolution of the waist circumference', 'timeFrame': 'V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)', 'description': 'Waist circumference (in cm), TOTUM-854 vs placebo'}, {'measure': 'Evolution of the hip circumference', 'timeFrame': 'V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)', 'description': 'Hip circumference (in cm), TOTUM-854 vs placebo'}, {'measure': 'Evolution of the cardiovascular disease risk (SCORE value)', 'timeFrame': 'V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)', 'description': 'Systematic Coronary Risk Estimation value from Heartscore calculator, TOTUM-854 vs placebo'}, {'measure': 'Delay of occurence of pharmacological treatment requirement for hypertension from V1', 'timeFrame': 'V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)', 'description': 'Delay between V1 and the date at which the investigator will decide to withdraw the subject from the study because he needs a pharmacological treatment to treat his hypertension, TOTUM-854 vs placebo'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diet supplement', 'Plant extracts', 'Hygiene and dietary recommendations'], 'conditions': ['Prehypertension', 'Elevated Blood Pressure', 'Blood Pressure', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'This clinical study aims to assess the efficacy of TOTUM-854, a mix of 6 plant extracts, consumed twice a day on automated office blood pressure in subjects with moderately elevated blood pressure. The hypothesis is that TOTUM-854 is superior to placebo for decrease of automated office blood pressure after 12 weeks of consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Office Systolic Blood Pressure between 130 and 159 mmHg and Diastolic Blood Pressure \\< 100 mmHg\n* Body Mass Index (BMI) between 18.5 and 35 kg/m²\n* Weight stable within ± 5 % in the last three months\n* No significant change in food habits or in physical activity in the 3 months before the randomization and agreeing to keep them unchanged throughout the study\n\nMain Exclusion Criteria:\n\n* Known or suspected secondary hypertension\n* Subjects with a very high Cardio Vascular risk SCORE2 or SCORE2-OP according to their risk regions: (Subjects \\<50 years old: ≥7.5%; Subjects between 50 and 69 years old: ≥10%; Subjects ≥70 years old: ≥15%)\n* Known hypertensive retinopathy and/or hypertensive encephalopathy\n* History of spontaneous or drug-induced angioedema\n* Clinically significant valvular heart disease or severe aortic stenosis\n* History of an acute coronary syndrome (non-ST elevation myocardial infarction, ST-elevation myocardial infarction, and unstable angina pectoris), stroke, or transient ischemic attack within 6 months prior to inclusion\n* Newly diagnosed or suffering from a non-treated or uncontrolled metabolic disorder such as diabetes, dyslipidemia, thyroidal dysfunction or other metabolic disorder\n* Suffering from a severe chronic disease or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator'}, 'identificationModule': {'nctId': 'NCT05469503', 'acronym': 'INSIGHT', 'briefTitle': 'Effect of TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Valbiotis'}, 'officialTitle': 'A Randomized, Placebo-controlled, Double-blind Study to Assess the Effect of TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure', 'orgStudyIdInfo': {'id': 'VCT-009'}, 'secondaryIdInfos': [{'id': '2022-A00131-42', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TOTUM-854', 'description': 'Experimental active diet supplement TOTUM-854 3.71-g dose. Seven capsules per day to consume orally in two intakes', 'interventionNames': ['Dietary Supplement: TOTUM-854']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo comparator Seven capsules per day to consume orally in two intakes', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'TOTUM-854', 'type': 'DIETARY_SUPPLEMENT', 'description': '12 weeks of TOTUM-854 supplementation', 'armGroupLabels': ['TOTUM-854']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '12 weeks of placebo supplementation', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haskovo', 'country': 'Bulgaria', 'facility': 'Multiprofile Hospital for Active Treatment Cardiology Department', 'geoPoint': {'lat': 41.93415, 'lon': 25.55557}}, {'city': 'Panagyurishte', 'country': 'Bulgaria', 'facility': 'Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Cardiology Department', 'geoPoint': {'lat': 42.49518, 'lon': 24.19021}}, {'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Diagnostic Consultative Center VII-Plovdiv South district EOOD, Cabinet of Endocrinology', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Multiprofile Hospital for Active Treatment Sveta Karidad EAD, Cardiology Department', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Diagnostic Consultative Center XX- Sofia EOOD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont Ferrand PIC/CIC Inserm 1405', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Vitamed Gałaj i Cichomski sp.j', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Centrum Medyczne Linden', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Słupca', 'country': 'Poland', 'facility': 'Przychodnia Zespołu Lekarza Rodzinnego "Medyk"', 'geoPoint': {'lat': 52.28733, 'lon': 17.87192}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Centrum Medyczne Oporów', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'overallOfficials': [{'name': 'Katarzyna Pałka, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centrum Medyczne Linden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Valbiotis', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Excelya', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}