Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-05 @ 5:51 PM
Study NCT ID:
NCT06432868
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Solarplast (R) Supplementation Effects Following High-intensity Resistance Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2024-04-29', 'studyFirstSubmitQcDate': '2024-05-22', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of Muscular Fatigue', 'timeFrame': 'Acute changes following exercise for 48 hours', 'description': 'Measure of Performance Change'}, {'measure': 'Rate of Muscular Fatigue', 'timeFrame': 'Change in Resting Values over 4 weeks of supplementation', 'description': 'Measure of Performance Change'}, {'measure': 'Lactate Dehydrogenase Activity', 'timeFrame': 'Acute changes following exercise for 48 hours', 'description': 'Marker of Muscle Damage'}, {'measure': 'Cortisol Concentration', 'timeFrame': 'Acute changes following exercise for 48 hours', 'description': 'Circulating Marker of Stress'}, {'measure': 'Cortisol Concentration', 'timeFrame': 'Change in Resting Values over 4 weeks of supplementation', 'description': 'Circulating Marker of Stress'}, {'measure': 'Glutathione (GSH) Activity', 'timeFrame': 'Change in Resting Values over 4 weeks of supplementation', 'description': 'Circulating Marker of Oxidative Stress'}, {'measure': 'Glutathione (GSH) Activity', 'timeFrame': 'Acute changes following exercise for 48 hours', 'description': 'Circulating Marker of Oxidative Stress'}, {'measure': 'Total Antioxidant Capacity', 'timeFrame': 'Change in Resting Values over 4 weeks of supplementation', 'description': 'Circulating Marker of Oxidative Stress'}, {'measure': 'Total Antioxidant Capacity', 'timeFrame': 'Acute changes following exercise for 48 hours', 'description': 'Circulating Marker of Oxidative Stress'}, {'measure': 'Interleukin 6 (IL-6) Concentration', 'timeFrame': 'Change in Resting Values over 4 weeks of supplementation', 'description': 'Circulating Marker of Inflammation'}, {'measure': 'Interleukin 6 (IL-6) Concentration', 'timeFrame': 'Acute changes following exercise for 48 hours', 'description': 'Circulating Marker of Inflammation'}, {'measure': 'Interleukin 10 (IL-10) Concentration', 'timeFrame': 'Change in Resting Values over 4 weeks of supplementation', 'description': 'Circulating Marker of Inflammation'}, {'measure': 'Interleukin 10 (IL-10) Concentration', 'timeFrame': 'Acute changes following exercise for 48 hours', 'description': 'Circulating Marker of Inflammation'}, {'measure': 'Tumor Necrosis Factor - alpha (TNFa) Concentration', 'timeFrame': 'Change in Resting Values over 4 weeks of supplementation', 'description': 'Circulating Marker of Inflammation'}, {'measure': 'Tumor Necrosis Factor - alpha (TNFa) Concentration', 'timeFrame': 'Acute changes following exercise for 48 hours', 'description': 'Circulating Marker of Inflammation'}, {'measure': 'Rate of Force Development', 'timeFrame': 'Change in Resting Values over 4 weeks of supplementation', 'description': 'Measure of Performance Change'}, {'measure': 'Peak Muscle Force', 'timeFrame': 'Acute changes following exercise for 48 hours', 'description': 'Measure of Performance Change'}, {'measure': 'Vertical Jump Height', 'timeFrame': 'Change in Resting Values over 4 weeks of supplementation', 'description': 'Measure of Performance Change'}], 'primaryOutcomes': [{'measure': 'Creatine Kinase Activity', 'timeFrame': 'Acute changes following exercise for 48 hours', 'description': 'Marker of Muscle Damage'}], 'secondaryOutcomes': [{'measure': 'Myoglobin Concentration', 'timeFrame': 'Acute changes following exercise for 24 hours', 'description': 'Marker of Muscle Damage'}, {'measure': 'Vertical Jump Height', 'timeFrame': 'Acute changes following exercise for 48 hours', 'description': 'Measure of Performance Change'}, {'measure': 'Mean Squat Velocity', 'timeFrame': 'Acute changes following exercise for 48 hours', 'description': 'Measure of Performance Change'}, {'measure': 'Peak Isometric Muscle Force', 'timeFrame': 'Acute changes following exercise for 48 hours', 'description': 'Measure of Performance Change'}, {'measure': 'Rate of Force Development', 'timeFrame': 'Acute changes following exercise for 48 hours', 'description': 'Measure of Performance Change'}, {'measure': 'Ratings of Perceived Soreness', 'timeFrame': 'Acute changes following exercise for 48 hours', 'description': 'Visual Analog Scale (1-100mm; low values indicate reduced soreness)'}, {'measure': 'Ratings of Perceived Fatigue', 'timeFrame': 'Acute changes following exercise for 48 hours', 'description': 'Visual Analog Scale (1-100mm; low values indicated reduced fatigue)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Muscle Damage']}, 'descriptionModule': {'briefSummary': 'The primary goal of this investigation is to assess whether Solarplast (R) supplementation will improve recovery following heavy resistance exercise in active adults. The primary questions to be addressed are:\n\nDoes Solarplast (R) decrease muscle damage and inflammation associated with heavy resistance exercise?\n\nDoes Solarplast (R) reduce the decline in performance associate with heavy resistance exercise?\n\nResearchers will compare Solarplast (R) to a placebo (a look-alike substance that contains no active ingredients) to see if Solarplast (R) is effective at improving recovery.\n\nParticipants will be asked to:\n\nTake Solarplast (R) or placebo daily for 4 weeks\n\nVisit the laboratory at least once per week to receive their supplement\n\nReport to the lab for 3 consecutive visits following supplementation to complete a heavy resistance training session and follow-up testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recreationally-active (participated in at least 2 weight training workouts per week over the previous year) and participates in at least 3h of total structured exercise/week as determined by the health and activity questionnaire.\n* Subject is judged by the Investigator to be healthy and free of any physical limitations (determined by health and activity questionnaire)\n* Subject has a body mass index of 18.0-34.9 kg/m2, inclusive\n* Subject is willing to maintain habitual diet throughout the study period\n* Subject is willing to abstain from dietary supplementation throughout the duration of the study.\n* Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators\n\nExclusion Criteria:\n\n* Subject is currently or will be enrolled in another clinical trial.\n* Subject is a habitual consumer of tea/antioxidants defined as \\> 8 oz/day of either green or black tea within the 14 days prior to the screening visit.\n* Subject has a history or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder.\n* Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.\n* Subject is unable to perform physical exercise (determined by health and activity questionnaire)\n* Subject is engaged in an extreme diet including but not limited to, Atkins, South Beach, Intermittent Fasting, etc.\n* Subject is allergic to the study product or placebo\n* Subject is taking any other nutritional supplement or performance enhancing drug (determined from health and activity questionnaire)\n* Subject has any chronic illness that causes continuous medical care\n* Taking any type of prescription or over-the-counter medication including but not limited to corticosteroids, non-steroidal anti-inflammatory drugs, and antibiotics within the 14 days prior to the screening visit.'}, 'identificationModule': {'nctId': 'NCT06432868', 'briefTitle': 'Solarplast (R) Supplementation Effects Following High-intensity Resistance Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Kent State University'}, 'officialTitle': 'Effects of Solarplast (R) Supplementation on Biomarkers of Muscle Damage, Inflammation and Recovery of Physical Performance Following High-intensity Resistance Exercise', 'orgStudyIdInfo': {'id': '927'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Solarplast (R)', 'description': '100mg/day of Solarplast (R) supplementation (28 days).', 'interventionNames': ['Dietary Supplement: Solarplast (R)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '100mg/day of Placebo (maltodextrin (98.8%) and medium chain triglycerides (1.2%)).', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Solarplast (R)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily supplementation for 28 days prior to heavy resistance exercise.', 'armGroupLabels': ['Solarplast (R)']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily supplementation for 28 days prior to heavy resistance exercise.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44242', 'city': 'Kent', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adam R Jajtner, PhD', 'role': 'CONTACT', 'email': 'ajajtner@kent.edu', 'phone': '330-672-0212', 'phoneExt': '20212'}], 'facility': 'Kent State University - Exercise Science & Exercise Physiology', 'geoPoint': {'lat': 41.15367, 'lon': -81.35789}}], 'centralContacts': [{'name': 'Adam R Jajtner, PhD', 'role': 'CONTACT', 'email': 'ajajtner@kent.edu', 'phone': '330-672-0212', 'phoneExt': '20212'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kent State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Adam Jajtner', 'investigatorAffiliation': 'Kent State University'}}}}