Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-04-16 @ 10:46 AM
Study NCT ID:
NCT03034668
Status:
COMPLETED
Last Update Posted:
2018-09-18
First Post:
2017-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Botanical Supplement Muscle Function and Lean Body Mass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-17', 'studyFirstSubmitDate': '2017-01-17', 'studyFirstSubmitQcDate': '2017-01-24', 'lastUpdatePostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal Isokinetic Leg Extension strength measured by dynamometry', 'timeFrame': 'Acute/Immediate'}, {'measure': 'Maximal Upper and Lower Body Strength measured by 1 repetition maximum', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Bench Press Repetitions to Fatigue', 'timeFrame': '8 weeks'}, {'measure': 'Leg Press Repetitions to Fatigue', 'timeFrame': '8 weeks'}, {'measure': 'Body Composition-Lean Mass', 'timeFrame': '8 weeks'}, {'measure': 'Body Composition-Fat Mass', 'timeFrame': '8 weeks'}, {'measure': 'Muscle cross sectional area', 'timeFrame': '8 weeks'}, {'measure': 'Change in Quality of Life Score from baseline to 8 weeks', 'timeFrame': 'baseline, 8 weeks', 'description': 'Quality of life from a visual analog scale (VAS) 0-100, with 0 = worst quality of life and 100=best quality of life.'}, {'measure': 'Change in Felt Arousal score from baseline to 8 weeks', 'timeFrame': 'baseline, 8 weeks', 'description': 'Felt arousal scale. Scores range 1-6 with 1 being low arousal and 6 being high. One score selected.'}, {'measure': 'Change in Mood score from baseline to 8 weeks', 'timeFrame': 'baseline; 8 weeks', 'description': 'Mood determined from a VAS. 0-100, with 0 = not depressed at all and 100 = most depressed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Botanical Supplement', 'Performance-Enhancing Supplement'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'Purpose: To evaluate the acute and chronic effects of a botanical supplement on strength, muscle function, and lean body mass\n\nParticipants: The acute phase will include 30 participants, and the chronic phase will include 84 participants. All participants must be healthy recreationally active males between the ages of 18 and 35 years.\n\nProcedures (methods):\n\nAcute phase: Participants will complete three testing visits as part of as part of a cross-over design, during which strength and muscle function will be assessed prior to and following consumption of a supplement. The experimental supplement is a blend of the botanical extracts; treatment arms will include a full dose (FULL; 350 mg capsule), half dose (HALF; 175 mg plus maltodextrin), or placebo (PLA; maltodextrin).\n\nChronic phase: Body composition, muscle cross-sectional area, a complete blood count and metabolic panel, subjective surveys, and strength will be measured prior to and following an 8-week supervised resistance training program, in conjunction with daily supplementation of FULL, HALF, or PLA.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recreationally Active (1- 4 hours of exercise/ sports participation per week and no more than 1 hour of resistance training exercise per week) for the previous 12 weeks.\n* BMI \\< 30 kg/m²\n* Have not smoked in the past year.\n* Participant has provided written and dated informed consent to participate in the study\n* Participant is willing and able to comply with the protocol\n* Participant is apparently healthy and free from disease, as determined by a health history questionnaire\n* Participant agrees to abstain from caffeine, tobacco, alcohol, and exercise within 24 hours of testing visits\n\nExclusion Criteria:\n\n* Participant has not used any dietary supplements within 12 weeks prior to enrollment and will not begin supplementation during the study. Potential supplements include but are not limited to Beta-alanine, Creatine, HMB, Carnosine, Taurine, androstenedione, DHEA, Whey protein, or a pre-workout supplement.\n* Participant has gained or lost 10 lbs in the previous 2 months.\n* Participant is currently enrolled in a separate clinical trial.\n* Participant has participated in a clinical trial within the previous 2 months that includes modifications to their physical and/or diet.\n* Participant has a known allergy or sensitivity to the placebo (maltodextrin) or active ingredients (Rhodiola \\& Rhaptonicum)\n* Participant consumes more than 8 cups (1 cup = 6 oz) of coffee per day on a regular basis\n* Participant consumes more than 3 alcoholic drinks per day.\n* Participant uses recreational drugs daily.\n* Previous physical symptoms causing a physician to recommend you to refrain from exercise.'}, 'identificationModule': {'nctId': 'NCT03034668', 'briefTitle': 'Botanical Supplement Muscle Function and Lean Body Mass', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'The Acute and Chronic Influence of a Botanical Supplement on Muscle Function and Lean Body Mass', 'orgStudyIdInfo': {'id': '16-1991'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CS16-003 Full dose', 'description': '350 mg capsule QD Rhodiola rosea L. \\& Rhaptonticum carthamoides extracts', 'interventionNames': ['Dietary Supplement: CS16-003 Full dose']}, {'type': 'EXPERIMENTAL', 'label': 'CS16-003 Half dose', 'description': '175 mg capsule QD 50% Rhodiola rosea L. \\& Rhaptonticum carthamoides extracts + 50% Maltodextrin', 'interventionNames': ['Dietary Supplement: CS16-003 Half dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Maltodextrin', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'CS16-003 Full dose', 'type': 'DIETARY_SUPPLEMENT', 'description': "350 mg 'Rhodiola rosea L. \\& Rhaptonticum carthamoides extracts", 'armGroupLabels': ['CS16-003 Full dose']}, {'name': 'CS16-003 Half dose', 'type': 'DIETARY_SUPPLEMENT', 'description': "175 mg 'Rhodiola rosea L. \\& Rhaptonticum carthamoides extracts + maltodextrin 175 mg", 'armGroupLabels': ['CS16-003 Half dose']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Maltodextrin: 350 mg', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina, Department of Exercise and Sport Science', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Eric Ryan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Givaudan France Naturals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}