Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-03-01 @ 2:45 AM
Study NCT ID:
NCT03076060
Status:
COMPLETED
Last Update Posted:
2017-10-26
First Post:
2017-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Very Low Calories Ketogenic Diet in Migraine.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055423', 'term': 'Diet, Ketogenic'}], 'ancestors': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-24', 'studyFirstSubmitDate': '2017-03-06', 'studyFirstSubmitQcDate': '2017-03-06', 'lastUpdatePostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Migraine attacks frequency', 'timeFrame': 'one-month', 'description': 'number of attacks per month'}], 'secondaryOutcomes': [{'measure': 'Migraine days', 'timeFrame': 'one-month', 'description': 'number of days with migraine per month'}, {'measure': 'Drug consumption', 'timeFrame': 'one-month', 'description': 'number of symptomatic drugs assumed per month to treat migraine'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ketogenic Diet', 'Very low calories diet', 'ketone bodies'], 'conditions': ['Migraine', 'Overweight and Obesity']}, 'referencesModule': {'references': [{'pmid': '25156013', 'type': 'RESULT', 'citation': 'Di Lorenzo C, Coppola G, Sirianni G, Di Lorenzo G, Bracaglia M, Di Lenola D, Siracusano A, Rossi P, Pierelli F. Migraine improvement during short lasting ketogenesis: a proof-of-concept study. Eur J Neurol. 2015 Jan;22(1):170-7. doi: 10.1111/ene.12550. Epub 2014 Aug 25.'}]}, 'descriptionModule': {'briefSummary': 'Ketogenesis is a physiologic phenomenon due to starvation or ketogenic diet (KD), a drastic restricted carbohydrate dietary regimen that induces lipid metabolism and ketone body (KB) synthesis. We followed, in a dietician clinical setting, a group of migraineurs who randomly received a one-month prescription of experimental diet, followed by a one-month of carbohydrate progressive reintroduction, then another one-month of experimental diet, followed by a one-month of carbohydrate progressive reintroduction. Experimental diets are a very-low calorie KD, or an isocaloric non-ketogenic diet.\n\nAim of our study is verify if during ketogenesis migraine improves.', 'detailedDescription': 'The ketogenic diet (KD) is a high-fat, low-carbohydrate diet for long used to treat refractory epilepsy. Ketogenesis, ketone-body formation, is a physiologic phenomenon also observed in patients following low-carbohydrate low-calorie diets for rapid weight loss. Different Authors evidenced a protective effect of ketone bodies also on migraine; however, KD effectiveness in this disorder is under scrutiny yet again. In fact, some concerns makes the matter a still open question: available studies were anecdotal, or conducted on small numbers; not all patients were diagnosed as migraineurs according to current headache classification; during ketogenesis there could be an avoidance of potentially trigger foods. Moreover, to comply with ketogenic diet, great motivation is needed and often migraineurs did not have it.\n\nAim of this study is verify in a double blind parallel group cross over design if ketogenesis is really able to prevent/avoid headache attacks in episodic migraineurs.\n\nMethods: Thirty-five consecutive episodic migraineurs, with an attack frequency higher than 2 attacks per months, will be enrolled. Two different kind of diet, a KD and a standard weight-loss diet (SD), will be consecutively administered in each patient recruited in the study for one month. Randomly patients will start with KD or SD. At the end of the second month differences between diets will be detected.\n\nKD will consist of 4 daily pharmaceutical meal substitutes composed by low-carbohydrate, low-fat, rich in protein serving of food, already commercially available. SD will consist in a similar eating program, with serving of food with addition of carbohydrate to avoid ketogenesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* kept a headache diary for at least 1 month\n* migraine disease onset before the age of 50\n* at least one migraine attack per month in the last 3 months\n* \\<15 days/month with headaches.\n\nExclusion Criteria:\n\n* prophylactic treatment in the previous 3 months\n* over consumption of acute anti-migraine medication (triptan, analgesic, or ergotamine)\n* pregnancy or lactation\n* type I diabetes\n* serious organic or psychiatric disorders that the investigators judged as having the potential to influence the trial evaluation.'}, 'identificationModule': {'nctId': 'NCT03076060', 'acronym': 'Ketomig', 'briefTitle': 'Very Low Calories Ketogenic Diet in Migraine.', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Randomised Controlled Crossover Double-blind Study on Very Low Calories Ketogenic Diet in Overweighted Migraine Patients.', 'orgStudyIdInfo': {'id': 'ChEmicrania'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Migraineurs', 'description': 'Overweighted or Obese migraineurs that refer to a dietician clinic to treat their ponderal condition.\n\nIntervention: 4-week of VLCKD by meal replacements poor in fats and carbohydrates.', 'interventionNames': ['Behavioral: Ketogenic diet']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham diet migraineurs', 'description': 'Overweighted or Obese migraineurs that refer to a dietician clinic to treat their ponderal condition.\n\nIntervention: 4-week of non-ketogenic VLCD by meal replacements poor in fats and proteins.', 'interventionNames': ['Behavioral: Sham Diet']}], 'interventions': [{'name': 'Ketogenic diet', 'type': 'BEHAVIORAL', 'otherNames': ['Very Low Calories Ketogenic Diet'], 'description': 'Two different kind of diet, a Very Low Calories Ketogenic Diet (KD) and a sham weight-loss diet (SD), will be consecutively administered in each patient recruited in the study for one month. To avoid the bias of different caloric intake, SD group will undergo to a non-ketogenic Very Low Calories Diet . Randomly patients will start with KD or SD.\n\nPatients assigned to this arm will follow the KD.', 'armGroupLabels': ['Migraineurs']}, {'name': 'Sham Diet', 'type': 'BEHAVIORAL', 'otherNames': ['Non-Ketogenic Very Low Calories Diet'], 'description': 'Two different kind of diet, a Very Low Calories Ketogenic Diet (KD) and a sham weight-loss diet (SD), will be consecutively administered in each patient recruited in the study for one month. To avoid the bias of different caloric intake, SD group will undergo to a non-ketogenic Very Low Calories Diet . Randomly patients will start with KD or SD.\n\nPatients assigned to this arm will follow the SD.', 'armGroupLabels': ['Sham diet migraineurs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00161', 'city': 'Rome', 'country': 'Italy', 'facility': 'Policlinico Umberto I', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Francesco Pierelli', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sapienza Univeristy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We do not share data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Cherubino DI LORENZO', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}