Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-05 @ 5:47 PM
Study NCT ID:
NCT06391957
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spirulina Supplementation In Recovery From Damaging Exercise
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-13', 'studyFirstSubmitDate': '2024-04-22', 'studyFirstSubmitQcDate': '2024-04-29', 'lastUpdatePostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure changes in the concentration of blood plasma inflammatory markers via immunoassay.', 'timeFrame': 'Measurements take place across a 6 day experimental period.', 'description': 'Blood plasma inflammatory markers will be measured before (baseline) and after eccentric exercise (at 3, 6, 24, 48 and 72 h post eccentric exercise) in both the spirulina and placebo group. Inflammatory markers that will be assessed include: interferon γ (IFN-γ), interleukin (IL) -1β, -4, -6, -10, tumour necrosis factor α (TNF-α) via immunoassay (pg/mL).'}], 'secondaryOutcomes': [{'measure': 'Measure changes in muscle function of the quadriceps using knee extensor peak isometric torque on a Biodex System 3 isokinetic dynamometer.', 'timeFrame': 'Measurements take place across a 6 day experimental period.', 'description': 'Knee extensor peak isometric torque (three maximal isometric contractions at 75◦ of knee flexion) will be measured before (baseline) and after eccentric exercise (at 3, 6, 24, 48 and 72 h post eccentric exercise) in both the spirulina and placebo group to report recovery of peak isometric torque (N). Testing will be performed on a Biodex System 3 isokinetic dynamometer (Biodex Medical Systems, Shirley, NY, US).'}, {'measure': 'Measure changes in muscle function of the quadriceps using knee extensor total isokinetic work on a Biodex System 3 isokinetic dynamometer.', 'timeFrame': 'Measurements take place across a 6 day experimental period.', 'description': 'Knee extensor total isokinetic work (area under the torque-time curve after 30 maximal, concentric, isokinetic knee extensor contractions performed at 75◦/s through an 80◦ range of motion) will be measured before (baseline) and after eccentric exercise (at 3, 6, 24, 48 and 72 h post eccentric exercise) in both the spirulina and placebo group to report recovery of total isokinetic work (N.s). Testing will be performed on a Biodex System 3 isokinetic dynamometer (Biodex Medical Systems, Shirley, NY, US).'}, {'measure': 'Measure changes in perceived lower body muscle soreness via visual analogue scale questionnaire.', 'timeFrame': 'Measurements take place across a 6 day experimental period.', 'description': "Perceived lower body muscle soreness will be measured before (baseline) and after eccentric exercise (at 3, 6, 24, 48 and 72 h post eccentric exercise) in both the spirulina and placebo group to report recovery of muscle. Participants will stand from a seated position and rate the corresponding sensation of lower body muscle soreness on a 100-mm visual analogue scale anchored by 'no pain' at 0 mm and 'worst possible pain' at 100 mm."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spirulina', 'exercise recovery'], 'conditions': ['Damage Muscle']}, 'descriptionModule': {'briefSummary': 'Exercise can cause muscle damage, leading to a loss in muscle function, increased muscle soreness and inflammation. Evidence supports the use of nutritional strategies to help recovery. Spirulina is a type of algae. It is eaten as a food supplement as it is full of micronutrients, some which provide anti-inflammatory benefits. This work will assess the impact of taking spirulina supplements on recovery from hard exercise. Investigators will measure changes in muscle function, soreness and markers of inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Are available and willing to attend St Luke's Campus, Exeter\n* Age 18 - 40\n* BMI 18.5 - 30 kg/m2\n* The participant exercises / plays sport for \\> 2 h/week, but doesn't do structured resistance strength training\n* Self-reported as healthy (absence of injury or disease)\n* Have no known food allergy to algae\n* Are not taking any over the counter or prescribed medication that might interfere with study, e.g. anti-inflammatory medication\n* Non-smoker\n\nExclusion Criteria:\n\n* Are unable to attend St Luke's Campus, Exeter\n* Are out-with age range 18 - 40\n* BMI below 18.5 or above 30 kg/m2\n* The participant does not exercise\n* The participant does regular structured resistance strength training\n* Known injury or disease that might influence study outcomes\n* Have a known food allergy to algae\n* Are taking over the counter or prescribed medication that might interfere with study, e.g. anti-inflammatory medication\n* Smoker"}, 'identificationModule': {'nctId': 'NCT06391957', 'acronym': 'SPIRAL', 'briefTitle': 'Spirulina Supplementation In Recovery From Damaging Exercise', 'organization': {'class': 'OTHER', 'fullName': 'University of Exeter'}, 'officialTitle': 'Spirulina Supplementation In Recovery From Damaging Exercise', 'orgStudyIdInfo': {'id': '4530276'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spirulina supplement', 'description': '3g of spirulina supplement three times daily for 5 days.', 'interventionNames': ['Dietary Supplement: Spirulina supplement', 'Procedure: Eccentric exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo supplement', 'description': 'macronutrient matched placebo supplement three times daily for 5 days.', 'interventionNames': ['Procedure: Eccentric exercise', 'Dietary Supplement: Placebo supplement']}], 'interventions': [{'name': 'Spirulina supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants consume a 3g spirulina supplement 3 times daily for 5 consecutive days.', 'armGroupLabels': ['Spirulina supplement']}, {'name': 'Eccentric exercise', 'type': 'PROCEDURE', 'description': 'On the morning of Day 3 (where Day 1 is when participants start taking supplements), participants perform a single bout of eccentric exercise. The exercise protocol is performed on a single leg and involves 300 (10 sets of 30 repetitions separated by 120 seconds) voluntary maximal, isokinetic, eccentric contractions of the knee extensor. Exercise is performed using a Biodex System 3 isokinetic dynamometer (Biodex Medical Systems, Shirley, NY, USA), and contractions are performed at 60◦/s over an 80◦ range of motion.', 'armGroupLabels': ['Placebo supplement', 'Spirulina supplement']}, {'name': 'Placebo supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants consume a macronutrient matched placebo supplement 3 times daily for 5 consecutive days.', 'armGroupLabels': ['Placebo supplement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Exeter', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ellen Williamson', 'role': 'CONTACT', 'email': 'ew655@exeter.ac.uk', 'phone': '07791054736'}], 'facility': 'University of Exeter', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}], 'centralContacts': [{'name': 'Benjamin Wall, Prof', 'role': 'CONTACT', 'email': 'b.t.wall@exeter.ac.uk', 'phone': '+441392724774'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Exeter', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}