Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-02 @ 11:14 PM
Study NCT ID:
NCT06804460
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-03
First Post:
2025-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Vegan Mediterranean Diet on Cardiometabolic Biomarkers, Functional Capacity, and Quality of Life in Patients with Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-04-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2025-01-27', 'studyFirstSubmitQcDate': '2025-01-31', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neutrophil to lymphocyte ratio', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Lymphocyte and neutrophil concentrations will be measured with the HemoCue® WBC DIFF system (HemoCue AB, Ängelholm, Sweden).The Neutrophil-to-Lymphocyte Ratio (NLR) is a simple inflammatory biomarker calculated by dividing neutrophil count by lymphocyte count. It reflects the balance between inflammation (neutrophils) and immune regulation (lymphocytes).\n\nAn elevated NLR is associated with chronic inflammation, physiological stress, or immune dysfunction, while lower levels indicate a more balanced immune state. Its ease of measurement and broad applicability make it valuable for monitoring inflammatory, cardiovascular, and oncological conditions.'}, {'measure': 'Lipid profile', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'The concentrations of total cholesterol and cholesterol-LDL will be measured with a POC multi-parameter lux meter (Biochemical Systems International, Italy).'}, {'measure': 'Cardiorespiratory fitness', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'The 30s Chair-to-Stand (CS) test assesses lower trunk strength by counting how many times a person can stand up and sit down within 30 seconds. It is commonly used to evaluate functional mobility and endurance in older adults or individuals with certain health conditions.'}, {'measure': 'Quality life', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': "The Fibromyalgia Impact Questionnaire (FIQ) examines the impact of fibromyalgia on daily life, covering areas such as functional capacity, pain, fatigue, sleep, and psychological well-being. Its revised version (FIQ-revised) focuses more on functional capacity, symptoms, and the overall impact of fibromyalgia on the individual's daily life."}, {'measure': 'Metabolic health', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Visceral fat is the fat stored within the abdominal cavity around internal organs. It is commonly measured to assess the risk of metabolic diseases, such as type 2 diabetes and cardiovascular conditions.'}], 'secondaryOutcomes': [{'measure': 'Metabolic health', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Fasting blood glucose measures the level of glucose in the blood after an overnight fast. It is used to assess insulin sensitivity and diagnose conditions like diabetes or prediabetes.'}, {'measure': 'Metabolic health', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Triglycerides are a type of fat (lipid) found in the blood, and their concentration is measured to assess cardiovascular health. High levels of triglycerides can increase the risk of heart disease and other metabolic conditions.'}, {'measure': 'Strength performance', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'handgrip strength test evaluate the strength of the hand and forearm muscles. It is commonly used as an indicator of overall muscle strength and functional capacity.'}, {'measure': 'Quality Life', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'The Tampa Scale for Kinesiophobia (TSK) will assess the degree of fear of movement or re-injury in individuals with pain or injury. The scale ranges from 17 (minimum) to 68 (maximum) points, with higher scores indicating a worse outcome, as they reflect greater fear of movement or re-injury. This tool helps understand how fear of movement can affect recovery and physical function.'}, {'measure': 'Quality life', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'The Pittsburgh Sleep Quality Index assesses the quality and patterns of sleep over a one-month period. It is commonly used to evaluate sleep disturbances and their impact on overall health and well-being.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fibromyalgia'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of a vegan Mediterranean diet compared to a traditional Mediterranean diet on inflammatory biomarkers, functional capacity, and quality of life in patients with fibromyalgia.', 'detailedDescription': 'The study involves two visits to the Exercise Physiology Research Laboratory at UFV. During the first visit, participants will complete functional capacity tests, respond to questionnaires (Fibromyalgia Impact Questionnaire, Short Form-36, MDF-Fibro-17, and Tampa Scale for Kinesiophobia), and provide a blood sample from the antecubital vein collected by an auxiliary nurse from the Eurofins MEGALABS laboratory. The biochemical markers to be analyzed include: white blood cell count (neutrophils, lymphocytes, monocytes, and platelets), lipid profile, fasting blood glucose levels and acute-phase proteins (C-reactive protein). Additionally, body composition will be assessed using a Tanita TBF300, and waist circumference will be measured. Functional capacity tests will include a handgrip strength test, a 30-second chair-to-stand test, and a timed up-and-go test. Participants will undergo a six-week dietary intervention and will return for a second visit at the end of the intervention period. They will be randomly assigned to follow either a vegan Mediterranean diet or a traditional Mediterranean diet, both of which will be guided and supervised by registered dietitians. These diets will be designed to meet individual energy needs and key nutrient requirements, following the standards set by the National Academy of Medicine and the Academy of Nutrition and Dietetics. Both diets will be isocaloric and maintain an identical macronutrient distribution. After the intervention, participants will repeat the same functional tests, questionnaires, and capillary blood measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged between 18 and 50 years.\n* Participants with a Fibromyalgia diagnosis according to the American College of Rheumatology (ACR) criteria.\n* Functional independence.\n* Non-smokers.\n* Low alcohol consumption (\\<1 serving/day).\n* Pharmacological treatment stabilized for at least 4 weeks prior to the start of the study.\n\nExclusion Criteria:\n\n* Pregnant, lactating, or menopausal women.\n* Physical condition that prevents the performance of functional capacity tests.\n* Change in pharmacological therapy during the intervention period.\n* Concomitant inflammatory conditions.'}, 'identificationModule': {'nctId': 'NCT06804460', 'acronym': 'FIBROVEG', 'briefTitle': 'Effect of a Vegan Mediterranean Diet on Cardiometabolic Biomarkers, Functional Capacity, and Quality of Life in Patients with Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Francisco de Vitoria'}, 'officialTitle': 'Effect of a Vegan Mediterranean Diet on Cardiometabolic Biomarkers, Functional Capacity, and Quality of Life in Patients with Fibromyalgia', 'orgStudyIdInfo': {'id': 'AGL-2024-46 project'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vegan Mediterranean diet', 'description': 'The vegan mediterranean diet is mainly composed of whole plant-based foods, similar to a Mediterranean diet, but the animal sources of protein and fat are substituted with plant foods rich in protein and fat. During the vegan diet, participants are supplemented with 1000 µg of cyanocobalamin (vitamin B12) twice a week (Harrison Sports Nutrition, Granada, Spain) to compensate for the deficiency in vitamin B12 intake induced by the vegan diet.', 'interventionNames': ['Behavioral: Dietary intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mediterranean diet', 'description': 'The traditional Mediterranean diet contains an abundant intake of whole plant-based foods, with moderate to low consumption of fish, poultry, low-fat dairy products, and eggs, very low consumption of red and processed meats, and no sweets. Olive oil is the main added fat, and animal protein accounts for 60% of total protein intake.', 'interventionNames': ['Behavioral: Dietary intervention']}], 'interventions': [{'name': 'Dietary intervention', 'type': 'BEHAVIORAL', 'description': 'The vegan mediterranean diet is mainly composed of whole plant-based foods, similar a una dieta mediterránea, but the animal sources of protein and fat are substituted with plant foods rich in protein and fat. During the vegan diet, participants are supplemented with 1000 µg of cyanocobalamin (vitamin B12) twice a week (Harrison Sports Nutrition, Granada, Spain) to compensate for the deficiency in vitamin B12 intake induced by the vegan diet.', 'armGroupLabels': ['Mediterranean diet', 'Vegan Mediterranean diet']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Miguel Dr. López Moreno, PhD', 'role': 'CONTACT', 'email': 'miguel.lopez@ufv.es', 'phone': '(+34) 647892334'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'In our study, the sharing of individual participant data (IPD) is not required as part of the trial registration process on ClinicalTrials.gov. The study does not involve sharing identifiable participant information or IPD for secondary analyses or public access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Francisco de Vitoria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Miguel López Moreno', 'investigatorAffiliation': 'Universidad Francisco de Vitoria'}}}}