Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT05898204
Status:
COMPLETED
Last Update Posted:
2025-08-14
First Post:
2023-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
KEtogenic Diet and Its Multiple EffectS on Obesity
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'}]}, '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients are sequentially allocated to one of the 2 arms of intervention: the ketogenic diet arm or the balanced diet arm.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-09', 'studyFirstSubmitDate': '2023-04-25', 'studyFirstSubmitQcDate': '2023-05-31', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of changes in Perceived Quality of Life with IWQOL-Lite Questionnaires', 'timeFrame': 'At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet', 'description': 'Assessment with the questionnaires Impact of weight/Quality of Life-Lite (IWQOL-Lite); global scale from 0 to 100; the higher the score, the better the quality of life'}, {'measure': 'Evaluation of changes in Perceived Quality of Life with SF-36 Questionnaires', 'timeFrame': 'At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet', 'description': 'Assessment with the questionnaires Short Form Health Survey 36 (SF-36); scale of every item from 0 to 100; the higher the score, the better the quality of life'}, {'measure': 'Evaluation of changes in Perceived Quality of Life with "EQ-5D" Questionnaires', 'timeFrame': 'At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet', 'description': 'Assessment with the questionnaires "EQ-5D"; scale of every item from 1 to 5; the higher the score, the worse the perceived problem'}], 'secondaryOutcomes': [{'measure': 'Evaluation of weight loss', 'timeFrame': 'At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet', 'description': 'Weight loss expressed in Kg'}, {'measure': 'Evaluation of changes of perceived sleep', 'timeFrame': 'At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet', 'description': 'Assessment with the questionnaires Pittsburgh Sleep Quality Index; global score on a scale from 0 to 21; the higher the score, the worse the sleep quality'}, {'measure': 'Evaluation of changes of perceived sleepiness', 'timeFrame': 'At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet', 'description': 'Assessment with the questionnaires Epworth Sleepiness Scale (ESS); score on a scale from 0 to 24; the higher the score, the higher the sleepiness'}, {'measure': 'Evaluation of changes in clock genes expression', 'timeFrame': 'At baseline, at 30 days', 'description': 'Evaluation of the expression of the clock genes in blood cells'}, {'measure': 'Evaluation of changes in hormonal profile', 'timeFrame': 'At baseline, at 30 days', 'description': 'Assessment of hormonal parameters, as cortisol, expressed in ug/dL'}, {'measure': 'Evaluation of changes in sexual function in males', 'timeFrame': 'At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet', 'description': 'Assessed with the questionnaires International Index of Erectile Function (IIEF-5); scale from 5 to 25; the higher the score, the better the erectile function'}, {'measure': 'Evaluation of changes in inflammation', 'timeFrame': 'At baseline, at 30 days, at 60 days if the patient continued the diet', 'description': 'Measurements of circulating cytokines, as interleukin 2 and interleukin 10, expressed in ng/mL'}, {'measure': 'Evaluation of changes of peripheral blood mononuclear cells', 'timeFrame': 'At baseline, at 30 days, at 60 days if the patient continued the diet', 'description': 'Number of cells of peripheral blood mononuclear cell subpopulations, expressed in number/mm3'}, {'measure': 'Evaluation of changes in sleep parameters (length)', 'timeFrame': 'At baseline, at 30 days', 'description': 'Assessment with actigraphy of latency, total minutes in bed, total sleep time, wake after sleep onset, average awakening length, expressed in minutes'}, {'measure': 'Evaluation of changes in hip circumference', 'timeFrame': 'At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet', 'description': 'Assessment of hip circumference, expressed in cm'}, {'measure': 'Evaluation of changes in waist circumference', 'timeFrame': 'At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet', 'description': 'Assessment of waist circumference, expressed in cm'}, {'measure': 'Change in circadian rhythm', 'timeFrame': 'At baseline, at 30 days', 'description': 'Evaluation of change in midpoint of sleep, bedtime, sleep onset, rise time and circadian phase, expressed in hours'}, {'measure': 'Evaluation of changes in Sexual Function in Females', 'timeFrame': 'At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet', 'description': 'Assessed with the questionnaire Female Sexual Function Index (FSFI); scale of every item from 1 to 5; the higher score, the better the sexual function'}, {'measure': 'Evaluation of changes in sleep efficiency', 'timeFrame': 'At baseline, at 30 days', 'description': 'Sleep efficiency expressed as a percentage; measurement with actigraphy'}, {'measure': 'Evaluation of changes in number of awakenings', 'timeFrame': 'At baseline, at 30 days', 'description': 'Measurement with actigraphy'}, {'measure': 'Evaluation of changes in sleep parameters', 'timeFrame': 'At baseline, at 30 days', 'description': 'Evaluation of sleep fragmentation index and movement index, with actigraphy'}, {'measure': 'Evaluation of changes in metabolic parameters', 'timeFrame': 'At baseline, at 30 days', 'description': 'Evaluation of changes in metabolic parameters, as glucose, triglycerides, cholesterol and HDL, expressed in mmol/L'}, {'measure': 'Evaluation of changes in BMI', 'timeFrame': 'At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet', 'description': 'Weight and height will be combined to report BMI in kg/m\\^2'}, {'measure': 'Evaluation of height', 'timeFrame': 'At baseline', 'description': 'Assessment of height, expressed in cm'}, {'measure': 'Evaluation of changes in whole blood cells gene expression', 'timeFrame': 'At baseline, at 30 days', 'description': 'Evaluation of the changes in the expression of blood cells genes, as metabolic, inflammatory and immunological genes, with RNA-seq in whole blood cells'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'metabolism', 'circadian rhythm', 'sleep', 'quality of life', 'balanced diet', 'ketogenic diet', 'immune profile'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The prevalence of obesity and metabolic disturbances is worryingly increasing worldwide, therefore the study of their pathophysiology is extremely important to find new strategies for their treatment. Obesity has a strong impact not only on the metabolism of the patients, but also may impact hormonal, inflammatory and immune profile, and profoundly influence the daily life of the patients. Weight loss may determine an amelioration of these parameters, but the impact of the diet composition aimed to weight loss on them has not been profoundly studied yet.\n\nThe aim of our research project is to study the effects of a ketogenic diet in comparison with an isocaloric balanced diet on weight loss and anthropometric parameters, quality of life, hormone profile, sleep, sexual function, circadian rhythm, inflammatory and immunological parameters in obese patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 65 years\n* BMI≥ 30 Kg/m2\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus and latent autoimmune diabetes in adults\n* β-cell failure in type 2 diabetes mellitus\n* Use of sodium/glucose cotransporter 2 (SGLT2) inhibitors\n* Pregnancy and breastfeeding\n* Kidney failure and moderate-to-severe chronic kidney disease\n* Liver failure\n* Heart failure (NYHA III-IV)\n* Respiratory failure\n* Unstable angina, stroke or myocardial infarction in the last 12 months\n* Cardiac arrhythmias\n* Eating disorders and other severe mental illnesses, alcohol and substance abuse\n* Active/severe infections\n* Planned elective surgery or invasive procedures\n* Rare disorders: porphyria, carnitine deficiency, carnitine palmitoyltransferase deficiency, carnitine-acylcarnitine translocase deficiency, mitochondrial fatty acid β-oxidation disorders, pyruvate carboxylase deficiency'}, 'identificationModule': {'nctId': 'NCT05898204', 'acronym': 'KEMESO', 'briefTitle': 'KEtogenic Diet and Its Multiple EffectS on Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Comparison of the Effects of a Ketogenic Diet and an Isocaloric Balanced Diet in Obese Patients: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'KEMESO1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketogenic diet arm', 'description': 'Ketogenic diet for a month, or a longer period if clinically necessary', 'interventionNames': ['Other: Ketogenic diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Balanced diet arm', 'description': 'Balanced diet for a month, or a longer period if clinically necessary', 'interventionNames': ['Other: Balanced diet']}], 'interventions': [{'name': 'Ketogenic diet', 'type': 'OTHER', 'description': 'Prescription of a ketogenic diet, 1200 Kcal/die. Patients are encouraged to walk 30 minutes every day.', 'armGroupLabels': ['Ketogenic diet arm']}, {'name': 'Balanced diet', 'type': 'OTHER', 'description': 'Prescription of a balanced diet, 1200 Kcal/die. Patients are encouraged to walk 30 minutes every day.', 'armGroupLabels': ['Balanced diet arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00161', 'city': 'Roma', 'state': 'Roma', 'country': 'Italy', 'facility': 'Sapienza University of Rome', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Lucio Gnessi', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}