Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
Study NCT ID:
NCT04453150
Status:
COMPLETED
Last Update Posted:
2022-07-06
First Post:
2020-04-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Microbiota in Dietary Approach to Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007662', 'term': 'Ketosis'}], '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'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, '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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-05', 'studyFirstSubmitDate': '2020-04-17', 'studyFirstSubmitQcDate': '2020-06-26', 'lastUpdatePostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in gut microbiota composition', 'timeFrame': 'Baseline, 12 weeks', 'description': 'To evaluate changes in gut microbiota composition from baseline using different strategies for weight loss which increase ketone bodies in comparison to a standard hypocaloric diet. Change from baseline in 16S rRNA amplicons of fecal community DNA at 3 months and 6 months'}], 'secondaryOutcomes': [{'measure': 'Changes in weight', 'timeFrame': 'Baseline, 12 weeks', 'description': 'To analyze the effect of hypocaloric diets which increase ketone bodies on anthropometric parameters in comparison to a standard hypocaloric diet'}, {'measure': 'Changes in body mass index.', 'timeFrame': 'Baseline, 12 weeks', 'description': 'To analyze the effect of hypocaloric diets which increase ketone bodies on body mass index in comparison to a standard hypocaloric diet'}, {'measure': 'Changes in waist circumference.', 'timeFrame': 'Baseline, 12 weeks', 'description': 'To analyze the effect of hypocaloric diets which increase ketone bodies on the waist circumference in comparison to a standard hypocaloric diet'}, {'measure': 'Changes in body composition.', 'timeFrame': 'Baseline, 12 weeks', 'description': 'To analyze the effect of hypocaloric diets which increase ketone bodies on anthropometric parameters in comparison to a standard hypocaloric diet measured by bioelectrical impedance analysis'}, {'measure': 'Changes in brown adipose tissue.', 'timeFrame': 'Baseline, 12 weeks', 'description': 'To analyze the effect of hypocaloric diets which increase ketone bodies on brown adipose tissue in comparison to a standard hypocaloric diet, measured by Positron emission tomography with 18F-fluorodeoxyglucose (18F-FDG PET).'}, {'measure': 'Changes in uncoupling protein 1 (UCP1)', 'timeFrame': 'Baseline, 12 weeks', 'description': 'To analyze the effect of hypocaloric diets which increase ketone bodies on brown adipose tissue UCP1 in comparison to a standard hypocaloric diet using a sample of subcutaneous white adipose tissue assessed by mRNA qPCR.'}, {'measure': 'Changes in physical activity.', 'timeFrame': 'Baseline, 12 weeks', 'description': 'To analyze the effect of hypocaloric diets which increase ketone bodies on physical activity in comparison to a standard hypocaloric diet measured by accelerometry'}, {'measure': 'Changes in blood pressure', 'timeFrame': 'Baseline, 12 weeks', 'description': 'To analyze the effect of hypocaloric diets which increase ketone bodies over the cardiovascular system in comparison to a standard hypocaloric diet based on blood pressure'}, {'measure': 'Changes in the punctuation in neurocognitive test', 'timeFrame': 'Baseline, 12 weeks', 'description': 'To analyze the effect of hypocaloric diets which increase ketone bodies on neurocognition, in comparison to a standard hypocaloric diet, measured by neurocognitive test'}, {'measure': 'Changes in heart rate', 'timeFrame': 'Baseline, 12 weeks', 'description': 'To analyze the effect of hypocaloric diets which increase ketone bodies on heart function measured by heart rate in comparison to a standard hypocaloric diet, measured by Holter.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ketosis', 'Microbiota'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '40598397', 'type': 'DERIVED', 'citation': 'Martinez-Montoro JI, Bandera B, Gutierrez-Bedmar M, Gomez-Perez AM, Macias-Gonzalez M, Moreno-Indias I, Tinahones FJ. Effect of a ketogenic diet, time-restricted eating, or alternate-day fasting on weight loss in adults with obesity: a randomized clinical trial. BMC Med. 2025 Jul 1;23(1):368. doi: 10.1186/s12916-025-04182-z.'}, {'pmid': '40335161', 'type': 'DERIVED', 'citation': 'Mela V, Heras V, Iesmantaite M, Garcia-Martin ML, Bernal M, Posligua-Garcia JD, Subiri-Verdugo A, Martinez-Montoro JI, Gomez-Perez AM, Bandera B, Moreno-Indias I, Tinahones FJ. Microbiota fasting-related changes ameliorate cognitive decline in obesity and boost ex vivo microglial function through the gut-brain axis. Gut. 2025 Oct 8;74(11):1828-1846. doi: 10.1136/gutjnl-2025-335353.'}]}, 'descriptionModule': {'briefSummary': 'Main aim: Study the anthropometric, metabolic, cardiovascular and neurocognitive and gut microbiota changes of different approaches for the weight reduction that increase the ketone bodies in a different proportion in relation to the classic hypocaloric diet.\n\nObjective 1: Study the effect of hypocaloric diets that increase the ketone bodies on gut microbiota and its relationship with anthropometric changes and of the Brown adipose tissue, Objective 2: with the metabolic and inflammatory changes, Objective 3: on the cardiovascular system, Objective 4: on the neurocognition, Objective 5: if they are associated to epigenetic changes that may explain the changes found in the other objectives. Objective 6: Determine the safety of the diets that increase the ketone bodies compared to the classic hypocaloric diet, Objective 7: if the effects of the different dietary approaches are maintained during the medium time, and Objective 8: Verify in experimental models (microbiota transplants from humans with different diets to germ-free mice, ketosis dietary models, and ketone bodies administration) the causality of the gut microbiota of these findings.\n\nMethodology: Model 1: Dietary intervention in humans with 4 types of diet with a different increase of the ketone bodies: classic hypocaloric diet (DH); diet with 8h of feeding and 16h of starving in periods of 24h (D16); diet with intermittent caloric restriction (DA); and normal in protein and low in carbohydrates hypocaloric ketogenic diet (DC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obesity (BMI≥30-45 kg/m2)\n\nExclusion Criteria:\n\n* Type 2 diabetes mellitus\n* Patients with major cardiovascular events in the 6 months prior to the study beginning.\n* Previous or current history of inflammatory disease.\n* Active infectious disease.\n* The refusal of the patient to participate in the study\n* Consumption of probiotics or prebiotics\n* Antibiotic therapy in the 3 months prior to the study'}, 'identificationModule': {'nctId': 'NCT04453150', 'briefTitle': 'Microbiota in Dietary Approach to Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud'}, 'officialTitle': 'Ketone Bodies and Gut Microbiota Role in the Dietetic Approach of Obesity', 'orgStudyIdInfo': {'id': 'ISCIII CP18/01160'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard hypocaloric diet', 'description': 'Mediterranean diet based on olive oil as main fat and regular consumption of vegetables (2 daily rations), fruits 3 daily rations), legumes (3 weekly rations), fish (3 weekly rations), with low consumption of red meat and meat products (less than twice a week), dairy foods (less than once a week) and no sweets, pastries or sugary drinks. Diet will produce a 600 kcal per day caloric deficit, according to the Harris-Benedict equation for each subject. Diet will include 45% carbohydrates, 35% fat, 20% protein distributed in at least 4 meals (breakfast, lunch, afternoon snack and dinner).', 'interventionNames': ['Other: Standard hypocaloric die']}, {'type': 'EXPERIMENTAL', 'label': 'Intermittent fasting 16/8 (early fasting)', 'description': 'Diet will produce a 600 kcal per day caloric deficit, according to the Harris-Benedict equation for each subject. Diet will include 45% carbohydrates, 35% fat, 20% protein, but it will be consumed for 8 hours a day (from 12 am. to 8 pm.), maintaining 16 fasting hours (from 8 pm. to 12 am. the following day).', 'interventionNames': ['Other: Intermittent fasting 16/8 (early fasting)']}, {'type': 'EXPERIMENTAL', 'label': 'Intermittent fasting 16/8 (late fasting)', 'description': 'Diet will produce a 600 kcal per day caloric deficit, according to the Harris-Benedict equation for each subject. Diet will include 45% carbohydrates, 35% fat, 20% protein, but it will be consumed for 8 hours a day (from 8 am. to 4 pm.), maintaining 16 fasting hours (from 4 pm. to 8 am. the following day).', 'interventionNames': ['Other: Intermittent fasting 16/8 (late fasting)']}, {'type': 'EXPERIMENTAL', 'label': 'Alternate-day fasting', 'description': 'In this diet subjects alternate norm caloric diet during 24 h (according to Harris-Benedict equation) and a diet including only 25% of caloric requirements the following 24 h (this day diet will include 5 % carbohydrates, 65% fat and 30% high biological value protein).', 'interventionNames': ['Other: Alternate-day fasting']}, {'type': 'EXPERIMENTAL', 'label': 'Ketogenic diet', 'description': 'Diet will produce a 600 kcal per day caloric deficit, according to the Harris-Benedict equation for each subject. Diet will include 5 % carbohydrates, 65% fat and 30% high biological value protein.', 'interventionNames': ['Other: Ketogenic diet']}], 'interventions': [{'name': 'Standard hypocaloric die', 'type': 'OTHER', 'description': 'Standard hypocaloric diet', 'armGroupLabels': ['Standard hypocaloric diet']}, {'name': 'Intermittent fasting 16/8 (early fasting)', 'type': 'OTHER', 'description': 'Intermittent fasting 16/8 (early fasting)', 'armGroupLabels': ['Intermittent fasting 16/8 (early fasting)']}, {'name': 'Intermittent fasting 16/8 (late fasting)', 'type': 'OTHER', 'description': 'Intermittent fasting 16/8 (late fasting)', 'armGroupLabels': ['Intermittent fasting 16/8 (late fasting)']}, {'name': 'Alternate-day fasting', 'type': 'OTHER', 'description': 'Alternate-day fasting', 'armGroupLabels': ['Alternate-day fasting']}, {'name': 'Ketogenic diet', 'type': 'OTHER', 'description': 'Ketogenic diet', 'armGroupLabels': ['Ketogenic diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Virgen de la Victoria Hospital', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}], 'overallOfficials': [{'name': 'Francisco J. Tinahones, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Investigacion Biomedica de Malaga'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}