Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-01-11 @ 10:39 PM
Study NCT ID:
NCT02923102
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2016-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Recoverben® on Recovery After Exhaustive Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063806', 'term': 'Myalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C008315', 'term': 'maltodextrin'}]}}, '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': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-01', 'studyFirstSubmitDate': '2016-09-28', 'studyFirstSubmitQcDate': '2016-09-30', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of muscle soreness (VAS) over time', 'timeFrame': 'Chance over time after 10 days of supplementation (pre stress test and 3h, 24h, 48 h, 96h after stress test)', 'description': 'In the current study, pain following eccentric exercise will be assessed by using a 100 mm visual analogue scale after the subjects performing a standardized movement.'}], 'secondaryOutcomes': [{'measure': 'Monitoring of related adverse events', 'timeFrame': 'During study execution over 15 days', 'description': 'Reporting of adverse effects to evaluate tolerability'}, {'measure': 'Change of maximal concentric strength/ maximal voluntary contraction (MVC) over time', 'timeFrame': 'Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test)', 'description': 'Maximal concentric strength of the M. Quadriceps femoris will be assessed by measuring maximal isometric concentric strength using a dynamometer'}, {'measure': 'Change of pressure pain (Algometry) over time', 'timeFrame': 'Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test)', 'description': 'The threshold for pressure induced pain will be measured using an algometer.'}, {'measure': 'Change of retrospective pain (Likert scale) over time', 'timeFrame': 'Chance over time after 10 days of supplementation (pre stress test and 24h, 48h, 96h after stress test)', 'description': 'Evaluation of the perceived pain retrospectively by using the Likert scale for muscle soreness'}, {'measure': 'Change of creatine kinase over time', 'timeFrame': 'Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test)'}, {'measure': 'Change of of glutathione peroxidase over time', 'timeFrame': 'Chance over time after 10 days of supplementation (pre stress test and 24h and 48 h after stress test)'}, {'measure': 'Change of interleukin-6 over time', 'timeFrame': 'Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Recovery', 'Muscle soreness', 'Lemon Verbena'], 'conditions': ['Healthy Volunteers', 'Muscle Fatigue', 'Muscle Soreness']}, 'referencesModule': {'references': [{'pmid': '29410606', 'type': 'DERIVED', 'citation': 'Buchwald-Werner S, Naka I, Wilhelm M, Schutz E, Schoen C, Reule C. Effects of lemon verbena extract (Recoverben(R)) supplementation on muscle strength and recovery after exhaustive exercise: a randomized, placebo-controlled trial. J Int Soc Sports Nutr. 2018 Jan 23;15:5. doi: 10.1186/s12970-018-0208-0. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate a pre and post workout supplementation (15 days) with Recoverben® , a Aloysia citriodora extract on recovery after exhaustive exercise. Effects will be investigated with 400mg Recoverben® and compared to placebo.', 'detailedDescription': 'The aim of the study is to investigate a pre and post workout supplementation (15 days) with Recoverben® , a Aloysia citriodora extract on recovery after exhaustive exercise. Effects will be investigated with 400mg Recoverben® and compared to placebo.\n\nTargeted parameter will be determined at the beginning of the study and after supplementation, each. Parameter include maximal strength (MVC), muscle soreness (VAS), pain sensitivity (Algometry) and biomarkers (CK, IL-6, glutathione peroxidase).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations\n* Health volunteers: Subject is in good physical and mental health as established by medical his-tory, physical examination, electrocardiogram, vital signs, results of biochemistry and haematology\n* Men and women\n* Age ≥ 22 and ≤ 50 years\n* BMI: 19-30 kg/m2\n* Physically active 1-3 times per week\n* Nonsmoker\n* Able and willing to follow the study protocol procedures\n\nExclusion Criteria:\n\n* Relevant history, presence of any medical disorder or chronic intake of medication/dietary supplements (e.g. polyphenols, anti-inflammatory or anti-oxidative drugs or supplements, antihyper-tensive drugs) potentially interfering with this study at screening.\n* For this study clinically relevant abnormal laboratory, vital signs or physical findings at screening\n* Diabetes or serious cardiovascular diseases\n* Change of dietary habits within the 2 weeks prior to screening (for instance start of a diet high in vegetables and fruits (≥ 5 portions per day))\n* Diet high in vegetables and fruits ≥ 5 portions per day\n* Participants anticipating a change in their lifestyle or physical activity levels during the study.\n* Subjects not willing to abstain from intake of analgesic medication (e.g. Aspirin) 24 hours prior to visit 2 until visit 5.\n* Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study.\n* Known hypersensitivity to the study preparation or to single ingredients\n* Pregnant subject or subject planning to become pregnant during the study; breast-\n* Known HIV-infection\n* Known acute or chronic hepatitis B and C infection\n* Blood donation within 4 weeks prior to visit 1 or during the study.\n* Subject involved in any clinical or food study within the preceding month'}, 'identificationModule': {'nctId': 'NCT02923102', 'briefTitle': 'Effects of Recoverben® on Recovery After Exhaustive Exercise', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vital Solutions GmbH'}, 'officialTitle': 'Effects of Recoverben® on Recovery After Exhaustive Exercise in Healthy People - a Randomized, Double-blind, Placebo-controlled Study With Parallel Design', 'orgStudyIdInfo': {'id': 'BTS822/14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aloysia citriodora extract', 'description': 'Dietary Supplement: Aloysia citriodora extract', 'interventionNames': ['Dietary Supplement: Aloysia citriodora extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Formulation', 'description': 'Dietary Supplement: Maltodextrin (no active ingredient)', 'interventionNames': ['Dietary Supplement: Maltodextrin']}], 'interventions': [{'name': 'Aloysia citriodora extract', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Recoverben®'], 'description': '2 capsules with 200mg - daily dosage 400mg', 'armGroupLabels': ['Aloysia citriodora extract']}, {'name': 'Maltodextrin', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Placebo'], 'description': '2 capsules with 200mg - daily dosage 400mg', 'armGroupLabels': ['Placebo Formulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73728', 'city': 'Esslingen am Neckar', 'country': 'Germany', 'facility': 'Biotesys GmbH', 'geoPoint': {'lat': 48.73961, 'lon': 9.30473}}], 'overallOfficials': [{'name': 'Claudia Reule, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'BioTeSys GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vital Solutions GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}