Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-01-03 @ 7:03 AM
Study NCT ID:
NCT06480669
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2024-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Intermittent Fasting and Mediterranean Diet on the Physical Health of the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-04-11', 'releaseDate': '2025-03-26'}], 'estimatedResultsFirstSubmitDate': '2025-03-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D038441', 'term': 'Diet, Mediterranean'}], 'ancestors': [{'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-24', 'studyFirstSubmitDate': '2024-06-17', 'studyFirstSubmitQcDate': '2024-06-24', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemical values (mg/dL)', 'timeFrame': '12 weeks', 'description': 'Basal glucose, High-Density Lipoprotein, Low-Density Lipoprotein, total cholesterol, triglycerides, serum transferrin, urea, uric acid, creatinine.'}, {'measure': 'Blood Pressure (mmHg)', 'timeFrame': '12 weeks', 'description': 'Blood pressure (Systolic blood pressure, diastolic blood pressure)'}, {'measure': 'Anthropometric values (kg)', 'timeFrame': '12 weeks', 'description': 'Weight'}, {'measure': 'Anthropometric values (cm)', 'timeFrame': '12 weeks', 'description': 'Weight, waist circumference, hip circumference.'}, {'measure': 'Anthropometric values (kg/m^2)', 'timeFrame': '12 weeks', 'description': 'Body mass index.'}, {'measure': 'Anthropometric index (numerical rating scale)', 'timeFrame': '12 weeks', 'description': 'Atherogenic index of plasma, waist/hip ratio.'}, {'measure': 'Biochemical values (IU/L)', 'timeFrame': '12 weeks', 'description': 'Alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase'}, {'measure': 'Biochemical values (mg/L)', 'timeFrame': '12 weeks', 'description': 'C-Reactive Protein'}, {'measure': 'Biochemical values (µg/L)', 'timeFrame': '12 weeks', 'description': 'Serum ferritin'}, {'measure': 'Biochemical values (µg/dL)', 'timeFrame': '12 weeks', 'description': 'Iron'}, {'measure': 'Biochemical values (g/dL)', 'timeFrame': '12 weeks', 'description': 'Albumin'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Hypertension', 'Dyslipidemias', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The prevalence of chronic diseases is increasing globally. In recent years, intermittent fasting has emerged as an effective dietary pattern against some of the most common chronic diseases in the elderly, alongside the Mediterranean diet.\n\nThe objective was to determine whether a 12-hour daily intermittent fasting regimen combined with a Mediterranean diet can improve analytical and anthropometric values in the elderly.\n\nA total of 17 individuals of both sexes, over 60 years old, autonomous, and with preserved cognitive capacity participated. They were randomly divided into two groups: 8 people in the intervention group performed intermittent fasting along with a Mediterranean diet, and 9 in the control group adopted only a Mediterranean diet. The intervention lasted 3 months, with measurements taken at the beginning and end of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '61 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 60 years of age.\n* Belong to the Bombarda health centre.\n* Preserved cognitive capacity.\n* Autonomy for basic and instrumental activities of daily living.\n* Ability to follow a TRF and/or adopt a Mediterranean dietary pattern.\n\nExclusion Criteria:\n\n* Underweight (BMI \\<18.5).\n* Serious or chronic uncontrolled disease.\n* Specific treatment that could alter blood and/or anthropometric values.\n* Poorly controlled type 1 or type 2 insulin-dependent diabetes mellitus.\n* Present or past episode of eating disorder (ED).\n* High alcohol consumption.'}, 'identificationModule': {'nctId': 'NCT06480669', 'acronym': 'FASTMED', 'briefTitle': 'Impact of Intermittent Fasting and Mediterranean Diet on the Physical Health of the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Zaragoza'}, 'officialTitle': 'Impact of Intermittent Fasting and Mediterranean Diet on the Physical Health of the Elderly: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PI23/610'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Time Restricted Feeding (TRF)', 'description': '8 participants who followed a 12/12 Time Restricted Feeding (12 consecutive hours of fasting, from 20:30 to approximately 8:30 the following day).', 'interventionNames': ['Other: Time Restricted Feeding']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mediterranean diet', 'description': 'A control group consisting of 9 participants who followed a standard Mediterranean diet.', 'interventionNames': ['Other: Mediterranean Diet']}], 'interventions': [{'name': 'Time Restricted Feeding', 'type': 'OTHER', 'otherNames': ['TRF'], 'description': '8 participants who practiced a 12/12 TRF (12 hours of fasting, from approximately 20:30 to 8:30 the following day).', 'armGroupLabels': ['Time Restricted Feeding (TRF)']}, {'name': 'Mediterranean Diet', 'type': 'OTHER', 'description': 'A control group consisting of 9 participants who followed a standard Mediterranean diet.', 'armGroupLabels': ['Mediterranean diet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zaragoza', 'country': 'Spain', 'facility': 'University of Zaragoza', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Zaragoza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'María Isabel Iguacel Azorín', 'investigatorAffiliation': 'Universidad de Zaragoza'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-03-26', 'type': 'RELEASE'}, {'date': '2025-04-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'María Isabel Iguacel Azorín, Associate Professor, Universidad de Zaragoza'}}}}