Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-01-01 @ 3:08 AM
Study NCT ID:
NCT04818905
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2021-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Helichrysum Italicum Infusion Ingestion in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-26', 'studyFirstSubmitDate': '2021-03-25', 'studyFirstSubmitQcDate': '2021-03-25', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in resting energy expenditure', 'timeFrame': 'Change from baseline to 30 minutes and 120 minutes.', 'description': 'Resting energy expenditure will be determined with indirect calorimetry.'}, {'measure': 'Changes in fat oxidation', 'timeFrame': 'Change from baseline to 30 minutes and 120 minutes.', 'description': 'Substrate oxidation will be determined with indirect calorimetry.'}, {'measure': 'Respiratory quotient', 'timeFrame': 'Change from baseline to 30 minutes and 120 minutes.', 'description': 'Respiratory quotient will be determined with indirect calorimetry.'}, {'measure': 'Blood pressure', 'timeFrame': 'Change from baseline to 30 minutes and 120 minutes.', 'description': 'Systolic and diastolic blood pressures will be determined with blood pressure device (Omron M3)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bioactive compounds', 'functional beverages', 'metabolism', 'helath'], 'conditions': ['Energy Expenditure', 'Substrate Oxidation', 'Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '31505825', 'type': 'BACKGROUND', 'citation': "Konstantinidi M, Koutelidakis AE. Functional Foods and Bioactive Compounds: A Review of Its Possible Role on Weight Management and Obesity's Metabolic Consequences. Medicines (Basel). 2019 Sep 9;6(3):94. doi: 10.3390/medicines6030094."}, {'pmid': '15113710', 'type': 'BACKGROUND', 'citation': 'Manach C, Scalbert A, Morand C, Remesy C, Jimenez L. Polyphenols: food sources and bioavailability. Am J Clin Nutr. 2004 May;79(5):727-47. doi: 10.1093/ajcn/79.5.727.'}, {'pmid': '24239849', 'type': 'BACKGROUND', 'citation': 'Antunes Viegas D, Palmeira-de-Oliveira A, Salgueiro L, Martinez-de-Oliveira J, Palmeira-de-Oliveira R. Helichrysum italicum: from traditional use to scientific data. J Ethnopharmacol. 2014;151(1):54-65. doi: 10.1016/j.jep.2013.11.005. Epub 2013 Nov 14.'}, {'pmid': '23924724', 'type': 'BACKGROUND', 'citation': 'Soga S, Ota N, Shimotoyodome A. Stimulation of postprandial fat utilization in healthy humans by daily consumption of chlorogenic acids. Biosci Biotechnol Biochem. 2013;77(8):1633-6. doi: 10.1271/bbb.130147. Epub 2013 Aug 7.'}, {'pmid': '34451560', 'type': 'DERIVED', 'citation': 'Kenig S, Kramberger K, Petelin A, Bandelj D, Baruca Arbeiter A, Miklavcic Visnjevec A, Peeters K, Mohorko N, Sik Novak K, Jenko Praznikar Z. Helichrysum italicum ssp. italicum Infusion Promotes Fat Oxidation in Hepatocytes and Stimulates Energy Expenditure and Fat Oxidation after Acute Ingestion in Humans: A Pilot Study. Plants (Basel). 2021 Jul 23;10(8):1516. doi: 10.3390/plants10081516.'}]}, 'descriptionModule': {'briefSummary': 'The study evaluates the acute effects of Helichrysum italicum on resting energy expenditure and substrate oxidation in humans. The resting energy expenditure and substrate oxidation will be measured by indirect calorimetry at baseline and after ingestion of either Helichrysum italicum infusion or hot water.', 'detailedDescription': 'Bioactive compounds found in medicinal plants and plant extracts, such as polyphenols, represent the oldest and most widely used form of alternative or complementary treatments for the prevention and management of obesity. Their consumption is currently increasing in the population due to the high cost, potential adverse effects and limited benefits of currently available pharmaceutical drugs. Helichrysum italicum is a mediterranean plant with promising nutraceutical activities. The plant is known as a rich source of biologically active compounds such as polyphenolic antioxidants, which are recognized in the prevention of various non-communicable chronic diseases. However, most of its traditionally claimed uses have not yet been scientifically proven.\n\nThe proposed study will investigate the acute effect of Helichrysum italicum infusion on resting energy expenditure, substrate oxidation, respiratory quotient and blood pressure in a pilot study of 11 male adults. It will be designed as a crossover study. Half of the participants will consume the Helichrysum italicum infusion and the other half will consume hot water. After seven days of washout period the participants will consume the alternate beverage.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy, weight-stable (±3 kg in the last 3 months), normotensive, non-smokers, no use of dietary supplements or frequent use of medication and no known metabolic disorders.\n\nExclusion Criteria:\n\n* females, smoking, medications, dietary supplements, metabolic diseases, hypertensive'}, 'identificationModule': {'nctId': 'NCT04818905', 'acronym': 'SMILJ', 'briefTitle': 'Helichrysum Italicum Infusion Ingestion in Humans', 'organization': {'class': 'OTHER', 'fullName': 'University of Primorska'}, 'officialTitle': 'Effects of Helichrysum Italicum Infusion on Resting Energy Expenditure and Fat Oxidation in Humans', 'orgStudyIdInfo': {'id': 'SMILJ_pilot'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Helichrysum italicum infusion', 'description': '1 g of milled plant material (Helichrysum italicun) immersed in hot water (200 mL, 100 °C) for 10 minutes.', 'interventionNames': ['Dietary Supplement: Helichrysum italicum infusion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Hot water', 'description': 'The control beverage contained only hot water (200 mL, 100 ˚C).', 'interventionNames': ['Other: Hot water']}], 'interventions': [{'name': 'Helichrysum italicum infusion', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Active beverage'], 'description': 'Active beverage or control beverage consumption after overnight fasting and calorimetry measurement on a single subject. After seven days washout period follows the consumption of the alternate beverage and measurements.', 'armGroupLabels': ['Helichrysum italicum infusion']}, {'name': 'Hot water', 'type': 'OTHER', 'otherNames': ['Control beverage'], 'description': 'Active beverage or control beverage consumption after overnight fasting and calorimetry measurement on a single subject. After seven days washout period follows the consumption of the alternate beverage and measurements.', 'armGroupLabels': ['Hot water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6310', 'city': 'Izola', 'country': 'Slovenia', 'facility': 'University of Primorska, Faculty of Health Sciences', 'geoPoint': {'lat': 45.53661, 'lon': 13.66015}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Primorska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Zala Jenko Praznikar', 'investigatorAffiliation': 'University of Primorska'}}}}