Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT06479993
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Chlorella Supplementation on Running Performance
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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-24', 'studyFirstSubmitDate': '2024-02-02', 'studyFirstSubmitQcDate': '2024-06-24', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in maximal oxygen uptake', 'timeFrame': 'Following each 3-week supplementation period of either chlorella or placebo', 'description': 'Changes in cardiovascular fitness variables as measured by a Cardio Pulmonary Exercise Test following the submaximal run.'}, {'measure': 'Changes in oxygen consumption and oxygen cost', 'timeFrame': 'Following each 3-week supplementation period of either chlorella or placebo', 'description': 'Assessing the possible changes in oxygen consumption and oxygen cost (ml/kg/min) at 60% Gas Exchange threshold (GET), 80% GET, and 75% change as measured by a metabolic cart (Vyntus)'}, {'measure': 'Changes in the respiratory exchange ratio', 'timeFrame': 'Following each 3-week supplementation period of either chlorella or placebo', 'description': 'Assessing the possible changes in the respiratory exchange ratio at 60% Gas Exchange threshold (GET), 80% GET, and 75% change as measured by a metabolic cart (Vyntus)'}, {'measure': 'Changes in heart rate', 'timeFrame': 'Following each 3-week supplementation period of either chlorella or placebo', 'description': 'Assessing the possible changes in heart rate (bpm) at 60% Gas Exchange threshold (GET), 80% GET, and 75% change as measured by a metabolic cart (Vyntus)'}, {'measure': 'Changes in lactate', 'timeFrame': 'Following each 3-week supplementation period of either chlorella or placebo', 'description': 'Assessing the possible changes in blood lactate at 60% Gas Exchange threshold (GET), 80% GET, and 75% change, at maximal oxygen uptake, and 15-mins post maximal as measured by the Biosen.'}, {'measure': 'Changes in glucose', 'timeFrame': 'Following each 3-week supplementation period of either chlorella or placebo', 'description': 'Assessing the possible changes in blood glucose at 60% Gas Exchange threshold (GET), 80% GET, and 75% change, at maximal oxygen uptake, and 15-mins post maximal as measured by the Biosen.'}], 'secondaryOutcomes': [{'measure': 'Changes in nutritional status', 'timeFrame': 'Following each 3-week supplementation period of either chlorella or placebo', 'description': 'Assessing the possible changes in nutritional status (macro and micronutrient intake) as measured by food recall.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Running', 'VO2max', 'Lactate', 'Oxygen Consumption'], 'conditions': ['Athletes', 'Healthy']}, 'descriptionModule': {'briefSummary': "Algae, such as chlorella, are gaining popularity as a nutritious additive to whole food or as a supplement. They contain a variety of beneficial nutrients like vitamins, minerals, healthy fats, and amino acids, which can have positive effects on our health and possibly athletic performance. Chlorella, specifically, is a type of single-celled green algae that you can easily find in health stores worldwide. While there's some evidence suggesting that chlorella supplementation might improve submaximal and maximal performance for cyclists, it's unclear if it has the same impact on runners. To investigate this, the investigators aim to conduct a double-blind randomised placebo controlled study to see if taking chlorella daily for 3-weeks can enhance different aspects of running performance, both during low/moderate and intense exercise, among individuals who regularly engage in running.", 'detailedDescription': 'After signing the consent form, we will invite you to come to the ISEH laboratory on Tottenham Court Road so we can take some basic baseline readings. This should last up to 60 minutes and will also include a V̇o2max Test (visit 1). After this, you will be randomly allocated either start on chlorella or placebo first. After supplementation (for visit 2 and 3) you will be required to perform a submaximal running test which will entail running at 60% GET (gas exchange threshold), 80% GET, and 75% of the change from peak. This will then be shortly followed by an incremental test to fatigue.\n\nYou will then be required to undergo the exact same supplementation period on the alternative supplement with the same exercise test performed.\n\nYou will be required to come into the laboratory a total of 3 times. Each visit should take roughly 1 - 1.5 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-50.\n* Run regularly (3-4 times a week).\n* Train with a purpose to compete.\n* Consider running to be your main sport.\n* Be comfortable running continuously for over 30-minutes at moderate intensity.\n* Represent a local running club.\n\nExclusion Criteria:\n\n* Individuals taking blood thinners.\n* Known allergies to algae/mould and iodine.\n* Any illness/conditions identified on PARQ (please see attached PARQ)\n* Taking immunosuppressant medication'}, 'identificationModule': {'nctId': 'NCT06479993', 'briefTitle': 'The Influence of Chlorella Supplementation on Running Performance', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'The Influence of Chlorella Supplementation on Running Performance', 'orgStudyIdInfo': {'id': '21745/002.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chlorella supplementation', 'description': 'Supplementation of chlorella (6g/day for 3-weeks)', 'interventionNames': ['Dietary Supplement: Chlorella supplementation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo supplementation', 'description': 'Supplementation of placebo (6g/day for 3-weeks)', 'interventionNames': ['Dietary Supplement: Placebo supplementation']}], 'interventions': [{'name': 'Chlorella supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Supplementation with chlorella (6g/day for 3-weeks)', 'armGroupLabels': ['Chlorella supplementation']}, {'name': 'Placebo supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Supplementation with placebo - microcrystalline cellulose (6g/day for 3-weeks)', 'armGroupLabels': ['Placebo supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W1T 7HA', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Tom Gurney', 'role': 'CONTACT', 'email': 't.gurney@ucl.ac.uk'}], 'facility': 'University Colllege London (ISEH)', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Tom Gurney', 'role': 'CONTACT', 'email': 't.gurney@ucl.ac.uk', 'phone': '020 3447 2800'}], 'overallOfficials': [{'name': 'Tom Gurney', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College, London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}