Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-30 @ 11:59 PM
Study NCT ID:
NCT06076161
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2023-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spirulina Platensis Supplementation and Calorie Restriction in Obese Men : A Randomized Controlled Trial Protocol Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This study will use a randomized controlled trial triple blind study design with a pre-post design.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The number of respondents in this study amounted to 32 people. Respondents will be divided into 2 groups, namely the intervention group and the control group. The intervention group will be given spirulina platensis supplements at a dose of 2x2 /hr with a dose per capsule of 450 mg for 4 weeks with education about calorie restriction. The control group will be given placebo 2x2/day for 4 weeks with education on calorie restriction.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2023-09-19', 'studyFirstSubmitQcDate': '2023-10-06', 'lastUpdatePostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Cholesterol', 'timeFrame': '30 days', 'description': 'Total Cholesterol in mg/dL'}, {'measure': 'Insulin Resistance - HOMA-IR', 'timeFrame': '30 days', 'description': 'Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be measured using fasting blood sugar and blood glucose (both in mg/dL)'}], 'secondaryOutcomes': [{'measure': 'Body Mass Index (BMI)', 'timeFrame': '30 days', 'description': 'Weight in kilograms and height in centimeters. Weight and height will be combined to report BMI in kg/m\\^2'}, {'measure': 'Serum Superoxide Dismutase (SOD) Levels', 'timeFrame': '30 days', 'description': 'SOD levels in U/mL'}, {'measure': 'Serum Malondialdehyde (MDA) Levels', 'timeFrame': '30 days', 'description': 'MDA levels in mmol/L'}, {'measure': 'Body Fat Percentage', 'timeFrame': '30 days', 'description': 'Body fat percentage in percent'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '21686173', 'type': 'BACKGROUND', 'citation': 'Fernandez-Sanchez A, Madrigal-Santillan E, Bautista M, Esquivel-Soto J, Morales-Gonzalez A, Esquivel-Chirino C, Durante-Montiel I, Sanchez-Rivera G, Valadez-Vega C, Morales-Gonzalez JA. Inflammation, oxidative stress, and obesity. Int J Mol Sci. 2011;12(5):3117-32. doi: 10.3390/ijms12053117. Epub 2011 May 13.'}, {'pmid': '30814686', 'type': 'BACKGROUND', 'citation': 'Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019 May;15(5):288-298. doi: 10.1038/s41574-019-0176-8.'}, {'pmid': '30577684', 'type': 'BACKGROUND', 'citation': 'Dludla PV, Nkambule BB, Jack B, Mkandla Z, Mutize T, Silvestri S, Orlando P, Tiano L, Louw J, Mazibuko-Mbeje SE. Inflammation and Oxidative Stress in an Obese State and the Protective Effects of Gallic Acid. Nutrients. 2018 Dec 21;11(1):23. doi: 10.3390/nu11010023.'}, {'pmid': '19136980', 'type': 'BACKGROUND', 'citation': 'James WP. WHO recognition of the global obesity epidemic. Int J Obes (Lond). 2008 Dec;32 Suppl 7:S120-6. doi: 10.1038/ijo.2008.247.'}, {'pmid': '30253139', 'type': 'BACKGROUND', 'citation': 'Chooi YC, Ding C, Magkos F. The epidemiology of obesity. Metabolism. 2019 Mar;92:6-10. doi: 10.1016/j.metabol.2018.09.005. Epub 2018 Sep 22.'}, {'pmid': '9216458', 'type': 'RESULT', 'citation': 'Nielsen F, Mikkelsen BB, Nielsen JB, Andersen HR, Grandjean P. Plasma malondialdehyde as biomarker for oxidative stress: reference interval and effects of life-style factors. Clin Chem. 1997 Jul;43(7):1209-14.'}, {'pmid': '34466462', 'type': 'RESULT', 'citation': 'Rezaei N, Eftekhari MH, Tanideh N, Mokhtari M, Bagheri Z. Comparison of Antioxidant and Anti-Inflammatory Effects of Honey and Spirulina platensis with Sulfasalazine and Mesalazine on Acetic Acid-Induced Ulcerative Colitis in Rats. Galen Med J. 2019 Jun 10;8:e1095. doi: 10.31661/gmj.v8i0.1095. eCollection 2019.'}, {'pmid': '32967062', 'type': 'RESULT', 'citation': 'Zarezadeh M, Faghfouri AH, Radkhah N, Foroumandi E, Khorshidi M, Rasouli A, Zarei M, Mohammadzadeh Honarvar N, Hazhir Karzar N, Ebrahimi Mamaghani M. Spirulina supplementation and anthropometric indices: A systematic review and meta-analysis of controlled clinical trials. Phytother Res. 2021 Feb;35(2):577-586. doi: 10.1002/ptr.6834. Epub 2020 Sep 23.'}, {'pmid': '34235823', 'type': 'RESULT', 'citation': 'Naeini F, Zarezadeh M, Mohiti S, Tutunchi H, Ebrahimi Mamaghani M, Ostadrahimi A. Spirulina supplementation as an adjuvant therapy in enhancement of antioxidant capacity: A systematic review and meta-analysis of controlled clinical trials. Int J Clin Pract. 2021 Oct;75(10):e14618. doi: 10.1111/ijcp.14618. Epub 2021 Aug 4.'}, {'pmid': '31780031', 'type': 'RESULT', 'citation': 'Moradi S, Ziaei R, Foshati S, Mohammadi H, Nachvak SM, Rouhani MH. Effects of Spirulina supplementation on obesity: A systematic review and meta-analysis of randomized clinical trials. Complement Ther Med. 2019 Dec;47:102211. doi: 10.1016/j.ctim.2019.102211. Epub 2019 Oct 17.'}, {'pmid': '30275428', 'type': 'RESULT', 'citation': 'Hernandez-Lepe MA, Lopez-Diaz JA, Juarez-Oropeza MA, Hernandez-Torres RP, Wall-Medrano A, Ramos-Jimenez A. Effect of Arthrospira (Spirulina) maxima Supplementation and a Systematic Physical Exercise Program on the Body Composition and Cardiorespiratory Fitness of Overweight or Obese Subjects: A Double-Blind, Randomized, and Crossover Controlled Trial. Mar Drugs. 2018 Oct 1;16(10):364. doi: 10.3390/md16100364.'}, {'pmid': '32201580', 'type': 'RESULT', 'citation': 'DiNicolantonio JJ, Bhat AG, OKeefe J. Effects of spirulina on weight loss and blood lipids: a review. Open Heart. 2020 Mar 8;7(1):e001003. doi: 10.1136/openhrt-2018-001003. eCollection 2020.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/21686173/', 'label': 'Inflammation, oxidative stress, and obesity'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/30814686/', 'label': 'Obesity: global epidemiology and pathogenesis'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/30577684/', 'label': 'Inflammation and Oxidative Stress in an Obese State and the Protective Effects of Gallic Acid'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/30253139/', 'label': 'The epidemiology of obesity'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/34466462/', 'label': 'Comparison of Antioxidant and Anti-Inflammatory Effects of Honey and Spirulina platensis with Sulfasalazine and Mesalazine on Acetic Acid-Induced Ulcerative Colitis in Rats'}, {'url': 'https://doi.org/10.1016/j.jff.2022.105124', 'label': 'Anti-inflammatory and antithrombotic properties of polar lipid extracts, rich in unsaturated fatty acids, from the Irish marine cyanobacterium Spirulina subsalsa'}, {'url': 'https://cris.usil.edu.pe/en/publications/impact-of-spirulina-supplementation-on-obesity-related-metabolic-', 'label': 'Impact of spirulina supplementation on obesity-related metabolic disorders: A systematic review and meta-analysis of randomized controlled trials'}]}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to evaluate the effects of spirulina platensis supplementation and calorie restriction on anthropometric parameters, body composition, lipid profile, insulin resistance, serum superoxide dismutase (SOD) levels, and serum malondialdehyde (MDA) levels in men with obesity. The main question it aims to answer are:\n\nWhat is the effect of spirulina platensis supplementation and calorie restriction on anthropometric parameters, body composition, lipid profile, insulin resistance, serum Superoxide Dismutase levels, and serum Malondialdehyde levels in obese individuals?\n\nParticipants will be respondents were given spirulina supplements for 30 days with a dose of 2x2 capsules 450mg\n\nResearchers will compare intervention group with placebo group that weren't given spirulina supplementation to see if there is any effects on anthropometric parameters, body composition, lipid profile, insulin resistance, serum Superoxide Dismutase levels, and serum Malondialdehyde levels", 'detailedDescription': 'Spirulina supplement intervention on subjects with male gender aged 25-55 years, which will be intervened for 4 weeks / 30 days, before the intervention will be taken anthropometric parameters, body composition, lipid profile, insulin resistance, serum Superoxide Dismutase levels, and serum Malondialdehyde levels.\n\nAfter that, spirulina supplement intervention will be given at a dose of 2x2 / day, and follow-up will be carried out every week, after 30 hours of intervention,spirulina supplement distribution is carried out by research assistants every 2 days.\n\nWill be taken again to conduct anthropometric parameters, body composition, lipid profile, insulin resistance, serum Superoxide Dismutase levels, and serum Malondialdehyde levels.\n\nThe aim is to find out if there is an effect of spirulina supplementation on anthropometric parameters, body composition, lipid profile, insulin resistance, serum Superoxide Dismutase levels, and serum Malondialdehyde levels.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'Obese men', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male Age 25 - 55 years\n* BMI ≥ 30 kg/m2\n* Waist Circumference \\> 90 cm\n* Low physical activity (Sedentary life style)\n* If taking weight loss supplements are willing to stop the dietary supplements, food or drinks.\n* Not undergoing a diet program.\n\nExclusion Criteria:\n\n* History of kidney disease, atherosclerosis, cancer, and acute infections.\n* Post-surgery in the last 3 months.\n* Deficit in daily calorie requirement.\n* Smoking habit and alcohol dependence.\n* Use of hormonal drugs, antidepressant drugs, antibiotics, antidiuretic, glucocorticoids and use of vitamin or mineral supplements in the last three months.\n* Refusal to sign the informed consent and in the study if not completing all stages will be excluded.'}, 'identificationModule': {'nctId': 'NCT06076161', 'briefTitle': 'Spirulina Platensis Supplementation and Calorie Restriction in Obese Men : A Randomized Controlled Trial Protocol Study', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Diponegoro'}, 'officialTitle': 'Effect of Spirulina Platensis Supplementation and Calorie Restriction on Anthropometric, Body Composition, Lipid Profiles, Insulin Resistance, Stress Oxidative Biomarkers In Obese Men: A Randomized Controlled Trial Protocol Study', 'orgStudyIdInfo': {'id': 'CT-390'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spirulina supplementation and calorie restriction in obese men', 'description': 'Respondents will be divided into 2 groups, namely the intervention group and the control group. The intervention group will be given spirulina platensis supplements at a dose of 2x2 /hr with a dose per capsule of 450 mg for 4 weeks with education about calorie restriction.', 'interventionNames': ['Dietary Supplement: Spirulina supplementation and calorie restriction in obese men']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo capsules and calorie restriction in obese men', 'description': 'The control group will be given placebo 2x2/day for 4 weeks with education on calorie restriction.', 'interventionNames': ['Dietary Supplement: Spirulina supplementation and calorie restriction in obese men']}], 'interventions': [{'name': 'Spirulina supplementation and calorie restriction in obese men', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Placebo capsules'], 'description': 'The intervention group will be given spirulina platensis supplements at a dose of 2x2 /hr with a dose per capsule of 450 mg for 4 weeks with education about calorie restriction. The control group will be given placebo 2x2/day for 4 weeks with education on calorie restriction.', 'armGroupLabels': ['Placebo capsules and calorie restriction in obese men', 'Spirulina supplementation and calorie restriction in obese men']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50275', 'city': 'Semarang', 'state': 'Central Java', 'country': 'Indonesia', 'facility': 'Central Laboratory, UNDIP Academic Hospital (Rumah Sakit Nasional Diponegoro)', 'geoPoint': {'lat': -6.99306, 'lon': 110.42083}}], 'overallOfficials': [{'name': 'Adriyan Pramono, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nutrition Science, Faculty of Medicine, Diponegoro University, Semarang, Indonesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Based on the consent from the respondent that already written in inform consent, we cannot legally give the information to anyone else'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Diponegoro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Adriyan Pramono', 'investigatorAffiliation': 'Universitas Diponegoro'}}}}