Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-25 @ 4:01 PM
Study NCT ID:
NCT05010057
Status:
COMPLETED
Last Update Posted:
2021-08-18
First Post:
2021-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of New Zealand Blackcurrant (NZBC) Supplementation on Recovery Following Strenuous 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'], 'maskingDescription': 'Coded, capsules'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised, parallel design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-17', 'studyFirstSubmitDate': '2021-08-06', 'studyFirstSubmitQcDate': '2021-08-17', 'lastUpdatePostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in creatine kinase (CK) concentration at 72 hours post-exercise', 'timeFrame': 'At baseline (pre-exercise) and 72 hours post-exercise.', 'description': 'Serum biomarker for muscle damage'}, {'measure': 'Change from baseline in creatine kinase (CK) concentration at 96 hours post-exercise', 'timeFrame': 'At baseline (pre-exercise) and 96 hours post-exercise..', 'description': 'Serum biomarker for muscle damage'}], 'secondaryOutcomes': [{'measure': 'Change in maximum voluntary contraction (MVC) from baseline to 96 hours post-exercise', 'timeFrame': 'At baseline (pre-exercise) and post-exercise time points (at 0, 24, 48, 72 and 96 hours respectively).', 'description': 'Muscle function measure; maximal voluntary isometric contraction (torque, Nm) performed on isokinetic dynamometer'}, {'measure': 'Change in rating of Delayed Onset of Muscle Soreness (DOMS) from baseline to 96 hours post-exercise', 'timeFrame': 'At baseline (pre-exercise) and post-exercise time points (at 24, 48, 72 and 96 hours respectively).', 'description': "Self-reported perception of muscle soreness using a visual analogue scale (VAS), from 'no soreness' \\[0 mm\\] on the left anchor point to 'extremely sore' \\[100 mm\\] on the right"}, {'measure': 'Change in joint range of motion (ROM) from baseline to 96 hours post-exercise', 'timeFrame': 'At baseline (pre-exercise) and post-exercise time points (at 24, 48, 72 and 96 hours respectively).', 'description': 'Elbow ROM measured using a goniometer'}, {'measure': 'Change in mid arm circumference (MAC) from baseline to 96 hours post-exercise', 'timeFrame': 'At baseline (pre-exercise) and post-exercise time points (at 24, 48, 72 and 96 hours respectively).', 'description': 'Mid-upper arm circumference measured at the midpoint of the distance from the acromion process (acromiale) to the olecranon process (radiale).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise-induced muscle damage', 'Recovery', 'Supplementation', 'Oxidative stress', 'Anthocyanin', 'New Zealand blackcurrant'], 'conditions': ['Muscle Damage']}, 'descriptionModule': {'briefSummary': 'The study aims to examine the effect of a New Zealand blackcurrant (NZBC) supplement on markers of muscle damage and recovery following strenuous resistance exercise. The investigation will compare responses between an experimental (NZBC capsule, 300 mg/day) and placebo (PLA capsule, 300 mg sugar) group. Participants will attend a screening session where they will consent to the study, complete a pre-activity medical questionnaire and have their height, weight and resting blood pressure measured. If the participants meet the inclusion criteria they will perform a familarisation session on the muscle strength assessment. Participants will be randomized to NZBC or placebo groups, and consume one capsule in the morning (between 6-10 am) for 12 days. This is a double-blinded study, which means that the participant and the study team will not know which group the participants are assigned to until the study is over. On day 8 participants will perform a strenuous bout of upper body resistance exercise on the isokinetic dynamometer (exercise device). Muscle strength and soreness, arm circumference, and elbow range of motion will be measured, and a fasted blood sample will be collected, before and 24, 48, 72 \\& 96 hours after the muscle fatigue protocol (on days 9, 10, 11 \\& 12). A marker of muscle damage (creatine kinase \\[CK\\] concentration) will be measured in the blood samples. Participants will also be asked to complete a 6-day dietary record, beginning on day 7 and ending on the final day of testing (day 12).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and Females\n* 18 - 45 years old\n* BMI: 19 - 29.9 kg/m2\n* Healthy: no active disease process that could interfere with endpoints measured as determined by medical history\n\nExclusion Criteria:\n\n* Smoking and tobacco use\n* Takes medication \\[excluding contraception\\]\n* BMI ≥ 30 kg/m2\n* Hypertensive (diastolic \\> 90 and/or systolic blood pressure \\> 140 mmHg)\n* History of musculoskeletal upper limb injuries\n* Performs regular resistance exercise (\\> 2 sessions per week)\n* Uses dietary supplements that could influence muscle recovery or function (e.g. protein supplements, antioxidants etc)'}, 'identificationModule': {'nctId': 'NCT05010057', 'acronym': 'CurraNZ_MD', 'briefTitle': 'The Effect of New Zealand Blackcurrant (NZBC) Supplementation on Recovery Following Strenuous Exercise', 'organization': {'class': 'OTHER', 'fullName': 'University of Surrey'}, 'officialTitle': 'The Effect of New Zealand Blackcurrant (NZBC) Supplementation on Indices of Muscle Damage Following Strenuous Exercise', 'orgStudyIdInfo': {'id': 'UEC/2015/112/FHMS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'New Zealand blackcurrants (NZBC)', 'description': '1 NZBC capsule (containing 300 mg active cassis containing 105 mg of anthocyanins, i.e. 35-50 % delphinidin-3-rutinoside, 5-20 % delphinidin-3-glucoside, 30-45 % cyanidin-3-rutinoside, 3-10 % cyanidin-3-glucoside), consumed in the morning, for 12 days.', 'interventionNames': ['Dietary Supplement: New Zealand blackcurrants (NZBC)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (PLA)', 'description': '1 placebo capsule (containing 300 mg microcrystalline cellulose M102), consumed in the morning, for 12 days.', 'interventionNames': ['Dietary Supplement: Placebo (PLA)']}], 'interventions': [{'name': 'New Zealand blackcurrants (NZBC)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['NZBC extract supplement (Health Currancy Ltd [UK] / CurraNZ Ltd [NZ])'], 'description': 'NZBC capsules containing anthocyanin-rich blackcurrant extract', 'armGroupLabels': ['New Zealand blackcurrants (NZBC)']}, {'name': 'Placebo (PLA)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Placebo capsules'], 'description': 'Placebo capsules containing microcrystalline cellulose', 'armGroupLabels': ['Placebo (PLA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'GU2 7AD', 'city': 'Guildford', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Surrey Human Performance Institute', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}], 'overallOfficials': [{'name': 'Julie EA Hunt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Surrey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Will provide basic data spreadsheet upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Surrey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}