Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT05343858
Status:
COMPLETED
Last Update Posted:
2022-05-11
First Post:
2019-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-05', 'studyFirstSubmitDate': '2019-09-06', 'studyFirstSubmitQcDate': '2022-04-18', 'lastUpdatePostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum cholesterol', 'timeFrame': 'Change from baseline at 30 days', 'description': 'Biomarker of metabolic syndrome'}, {'measure': 'Serum HDL', 'timeFrame': 'Change from baseline at 30 days', 'description': 'Biomarker of lipid profile quality'}, {'measure': 'Serum LDL syndrome biomarker', 'timeFrame': 'Change from baseline at 30 days', 'description': 'Biomarker of lipid profile quality'}, {'measure': 'Triglycerides (TAG)', 'timeFrame': 'Change from baseline at 30 days', 'description': 'Biomarker of lipid profile quality'}, {'measure': 'Apolipoprotein A', 'timeFrame': 'Change from baseline at 30 days', 'description': 'Metabolic syndrome biomarker'}, {'measure': 'Apolipoprotein B', 'timeFrame': 'Change from baseline at 30 days', 'description': 'Metabolic syndrome biomarker'}], 'secondaryOutcomes': [{'measure': 'Blood count', 'timeFrame': 'Change from baseline at 30 days', 'description': 'Concentration of blood'}, {'measure': 'Body weight', 'timeFrame': 'Change from baseline at 30 days', 'description': 'Changes on anthropometric characteristics'}, {'measure': 'Tolerance', 'timeFrame': 'Change from baseline at 30 days', 'description': 'Occurrence and frequency of gastrointestinal symptoms'}, {'measure': 'Body Mass Index', 'timeFrame': 'Change from baseline at 30 days', 'description': 'Changes on anthropometric characteristics'}, {'measure': 'Waist circumference', 'timeFrame': 'Change from baseline at 30 days', 'description': 'Changes on anthropometric characteristics'}, {'measure': 'Adherence', 'timeFrame': 'Change from baseline at 30 days', 'description': 'Changes in the number of consumed pills'}, {'measure': 'Sensory perception Visual Analog Scale (VAS) rate from 1 to 100 related with flavor, aro', 'timeFrame': 'Change from baseline at 30 days', 'description': 'Visual Analog Scales (VAS) with a range between 0 (negative score) and 10 (positive score) related to taste, smell, texture, satiety and fullness'}, {'measure': 'Dietary intake', 'timeFrame': 'Change from baseline at 30 days', 'description': 'Changes in diet composition through 24-hour dietary record'}, {'measure': 'Glucose', 'timeFrame': 'Change from baseline at 30 days', 'description': 'Concentration of glucose'}, {'measure': 'Urate', 'timeFrame': 'Change from baseline at 30 days', 'description': 'Concentration of safety marker'}, {'measure': 'Creatinine', 'timeFrame': 'Change from baseline at 30 days', 'description': 'Concentration of creatinine'}, {'measure': 'Calcium', 'timeFrame': 'Change from baseline at 30 days', 'description': 'Concentration of minerals'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microalgae', 'lipid profile', 'metabolic syndrome', 'pilot'], 'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of the consumption of two microalgae Chlorella vulgaris and Arthrospira platensis (Spirulina) on some biomarkers of metabolic syndrome: Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, Apolipoprotein A and Apolipoprotein B, in overweight / obese subjects with altered lipid profile.', 'detailedDescription': 'A randomized, parallel, and double-blind pilot study with 3 study arms is being performed to evaluate the effect of the consumption of two unicellular microalgae: Chlorella vulgaris and Arthrospira platensis (Spirulina).\n\nThe investigators included 30 participants between 18 and 65 years (BMI ≥25 and \\<40 kg / m2). All volunteers will be randomized into 3 study groups, and participants will receive the 3 different study products during 30 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women from 18 to 65 years old.\n* Body Mass Index (BMI) ≥25 and \\<40 kg/m2.\n* Cardiovascular risk \\<10%\n* Adequate cultural level and understanding\n* Agree to participate in the study\n\nExclusion Criteria:\n\n* Subjects with BMI ≥40 or \\<25 kg /m2\n* Subjects diagnosed with Diabetes Mellitus.\n* Subjects with dyslipidemia on pharmacological treatment\n* Subjects with hypertension on pharmacological treatment\n* Subjects with established diagnosis of eating disorder\n* Smokers or those subjects with high alcohol consumption\n* Subjects under pharmacological treatment\n* Subjects with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet\n* Subjects with sensory problems\n* Subjects with gastrointestinal diseases that affect the digestion or absorption of nutrients\n* Pregnant or breastfeeding women\n* Women with menstrual irregularities\n* Subjects with intense physical activity\n* Subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption\n* Subjects with a diagnosis of celiac disease or a gluten intolerance'}, 'identificationModule': {'nctId': 'NCT05343858', 'acronym': 'ALGAENERGY', 'briefTitle': 'Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigación Hospital Universitario La Paz'}, 'officialTitle': 'Pilot Study to Evaluate the Effect of the Consumption of Two Unicellular Microalgae (Chlorella Vulgaris and Arthrospira Platensis (Spirulina)) on Metabolic Syndrome Biomarkers in Overweight / Obese Subjects With Altered Lipid Profile', 'orgStudyIdInfo': {'id': 'HULP 5296'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Spirulina platensis', 'description': '10 volunteers will consume 16g / day (in 2 doses of 8g) of a nutritional supplement of Spirulina platensis', 'interventionNames': ['Dietary Supplement: Experimental: Group 1: Spirulina platensis']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: Chlorella vulgaris', 'description': '10 volunteers will consume 16g / day (in 2 doses of 8g) of a nutritional supplement of Chlorella vulgaris', 'interventionNames': ['Dietary Supplement: Experimental: Group 2: Chlorella vulgaris']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 3: Control', 'description': '10 volunteers will consume 16g / day (in 2 doses of 8g) of a control supplement', 'interventionNames': ['Dietary Supplement: Placebo Comparator: Group 3: Control']}], 'interventions': [{'name': 'Experimental: Group 1: Spirulina platensis', 'type': 'DIETARY_SUPPLEMENT', 'description': '16 g/day (two doses of 8g)', 'armGroupLabels': ['Group 1: Spirulina platensis']}, {'name': 'Experimental: Group 2: Chlorella vulgaris', 'type': 'DIETARY_SUPPLEMENT', 'description': '16 g/day (two doses of 8g)', 'armGroupLabels': ['Group 2: Chlorella vulgaris']}, {'name': 'Placebo Comparator: Group 3: Control', 'type': 'DIETARY_SUPPLEMENT', 'description': '16 g/day (two doses of 8g)', 'armGroupLabels': ['Group 3: Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Institute for Health Research IdiPAZ', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Carmen Gómez-Candela', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'La Paz University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigación Hospital Universitario La Paz', 'class': 'OTHER'}, 'collaborators': [{'name': 'AlgaEnergy, S.A.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}