Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-01-04 @ 5:55 PM
Study NCT ID:
NCT03853603
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2019-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Investigate the Effects of a Food Supplement Santa Herba Extract on Weight Loss in Overweight Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2019-02-12', 'studyFirstSubmitQcDate': '2019-02-22', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight', 'timeFrame': 'day 85', 'description': 'electronic scale'}], 'secondaryOutcomes': [{'measure': 'Body fat (%)', 'timeFrame': 'Day 85', 'description': 'Body fat mass in kilograms (kg) and weight in kilograms (kg) will be combined to report Percent body fat in (kg/kg)\\*100 (%)'}, {'measure': 'BCM/ECM index', 'timeFrame': 'Day 85', 'description': 'Body cell mass (BCM) in kg and extracellular mass (ECM) in kg will be combined to report BCM/ECM index'}, {'measure': 'Waist-hip ratio (WHR)', 'timeFrame': 'Day 85', 'description': 'Waist circumference in centimetre (cm) and hip circumference in centimetre (cm) will be combined to report WHR in cm/cm'}, {'measure': 'Sagittal abdominal diameter (SAD) [cm]', 'timeFrame': 'Day 85', 'description': 'Sagittal abdominal diameter (SAD) or "supine abdominal height" is a simple anthropometric measure shown to be a marker of insulin resistance. SAD is measured after normal expiration at the level of iliac crest while in the supine position with bent knees on a firm examination table and without clothes in the measurement area. The measurement is performed with the Holtain-Kahn abdominal caliper.'}, {'measure': 'Concentration of lipid profile in serum', 'timeFrame': 'Day 85', 'description': 'Concentration of Cholesterol \\[mg/dL\\], triglycerides \\[mg/dL\\], LDL-cholesterol \\[mg/dL\\], HDL-cholesterol \\[mg/dL\\]'}, {'measure': 'Concentration of Lipokin in plasma', 'timeFrame': 'Day 85', 'description': '12,13-diHOME (12,13-Dihydroxyoctadec-9-enoic acid) \\[pmol/mL\\]'}, {'measure': 'Questionnaire about Appetite (AEBQ)', 'timeFrame': 'Day 85', 'description': 'The Adult Eating Behavior Questionnaire (Hunot et al. 2016) about perception of hunger and satiety including ravenousness appetite and snacking habits will be performed throughout the study. AEBQ is a questionnaire measuring 8 different appetitive traits.\n\nEnjoyment of food\n\nEmotional over-eating\n\nEmotional under-eating\n\nFood fussiness\n\nFood responsiveness\n\nSlowness in eating\n\nHunger\n\nSatiety responsiveness\n\nScale: 5-point Likert scale:\n\nStrongly disagree =1 Disagree =2 Neitheragree nor disagree =3 Agree =4 Strongly agree =5'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lipid profile', '12,13-diHOME'], 'conditions': ['Weight Loss']}, 'referencesModule': {'references': [{'pmid': '34255555', 'type': 'DERIVED', 'citation': 'Modinger Y, Schon C, Wilhelm M, Pickel C, Grothe T. A Food Supplement with Antioxidative Santa Herba Extract Modulates Energy Metabolism and Contributes to Weight Management. J Med Food. 2021 Nov;24(11):1235-1242. doi: 10.1089/jmf.2021.0016. Epub 2021 Jul 13.'}]}, 'descriptionModule': {'briefSummary': 'Aim of the study is to investigate the effect of a 12-week supplementation of Santa Herba Extract on body weight in overweight and obese subjects. Additionally appetite related marker as well as marker of white adipose tissue browning will be evaluated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is able and willing to follow the study protocol procedures to sign the Informed Consent Form prior to screening evaluations\n* Overweight and obese women with BMI 25 - 35 kg/m2 (limits included)\n* Age: 25 - 60 years\n* Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology\n\nExclusion Criteria:\n\n* Relevant history or presence of any medical disorder potentially interfering with this study (heavy depression, diabetes, active cancer, severe liver disease, heavy cardiovascular diseases (e.g. stroke, heart attack))\n* Chronic intake of medication/dietary supplements with impact on body weight or body composition or lipid modifying products (e.g. protein shakes, statins, omega-3 fatty acids, etc.) 2 months prior to screening or during the study; stable doses of e.g. hypertensive therapy and thyroid gland hormones are acceptable.\n* Change in hormonal contraceptive during or at least 3 months before the study\n* Consumption of any dietary supplement / fortified food (with exception of vitamin D and mineral supplements e.g. Ca, Mg)\n* Low body fat mass measured at screening with BIA ( bioelectrical impedance analysis ) (Cut off-value: \\<36% body fat).\n* Weight loss intervention or recent body weight change \\> 4.5 kg during last 3 months\n* Diet high in vegetables and fruits ≥ 5 portions per day\n* Vegan lifestyle\n* Smoker \\> 10 cigarettes / day\n* Gastrointestinal diseases/conditions (colitis ulcerosa, Crohn's disease, peptic ulcers, celiac disease)"}, 'identificationModule': {'nctId': 'NCT03853603', 'briefTitle': 'Clinical Study to Investigate the Effects of a Food Supplement Santa Herba Extract on Weight Loss in Overweight Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mibelle AG'}, 'officialTitle': 'Clinical Study to Investigate the Effects of a Food Supplement With Santa Herba Extract on Weight Loss and Modulation of Appetite-related Biomarkers in Overweight Women - a Randomized, Placebo-controlled Parallel Study', 'orgStudyIdInfo': {'id': 'BTS1235/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Maltodextrin', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Santa herba extract', 'description': 'Santa herba extract', 'interventionNames': ['Dietary Supplement: Santa herba']}], 'interventions': [{'name': 'Santa herba', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Santa herba dry extract; 400 mg/day. 2 capsules/day; 1 capsule twice daily with the main meals (lunch and dinner)', 'armGroupLabels': ['Santa herba extract']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Maltodextrin; 400 mg/day. 2 capsules/day; 1 capsule twice daily with the main meals (lunch and dinner)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73728', 'city': 'Esslingen am Neckar', 'country': 'Germany', 'facility': 'BioTeSys GmbH', 'geoPoint': {'lat': 48.73961, 'lon': 9.30473}}], 'overallOfficials': [{'name': 'Daniel Menzel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BioTeSys GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mibelle AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}