Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2026-01-08 @ 5:49 AM
Study NCT ID:
NCT04529161
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2020-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Olfactory and Taste Changes During Fasting Mimicking Diet (FMD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D000857', 'term': 'Olfaction Disorders'}], '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': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Patients will follow a 6-months period of FMD followed by a 6-months of routinary eating habits (Group A) or viceversa (Group B)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-07', 'studyFirstSubmitDate': '2020-08-18', 'studyFirstSubmitQcDate': '2020-08-26', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sniffing stick test change', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'Quantitative screening of olfactory performance'}, {'measure': 'Taste Strips', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'Quantitative assessment of taste performance'}], 'secondaryOutcomes': [{'measure': 'Incidence of abnormal laboratory tests results', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'serum glucose'}, {'measure': 'Incidence of abnormal laboratory tests results', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'Serum/plasma growth factors: IGF-1'}, {'measure': 'Incidence of abnormal laboratory tests results', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'Serum/plasma growth factors: IGFBP1/3'}, {'measure': 'Incidence of abnormal laboratory tests results', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'Serum/plasma growth factors: insulin'}, {'measure': 'Incidence of abnormal laboratory tests results', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'Serum/plasma growth factors: VEGF'}, {'measure': 'Incidence of abnormal laboratory tests results', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'plasma ghrelin.'}, {'measure': 'Incidence of abnormal laboratory tests results', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'Serum/plasma inflammatory markers: adiponectin'}, {'measure': 'Incidence of abnormal laboratory tests results', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'Serum/plasma inflammatory markers: c reactive protein'}, {'measure': 'Incidence of abnormal laboratory tests results', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'alanine aminotransferase'}, {'measure': 'Incidence of abnormal laboratory tests results', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'aspartate aminotransferase'}, {'measure': 'Incidence of abnormal laboratory tests results', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'total cholesterol'}, {'measure': 'Incidence of abnormal laboratory tests results', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'triglycerides'}, {'measure': 'Incidence of abnormal laboratory tests results', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'high density lipoprotein cholesterol'}, {'measure': 'Incidence of abnormal laboratory tests results', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'low-density lipoprotein cholesterol'}, {'measure': 'Incidence of abnormal laboratory tests results', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'erythrocyte sedimentation rate'}, {'measure': 'Incidence of abnormal laboratory tests results', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'conjugated and unconjugated bilirubin'}, {'measure': 'Incidence of abnormal laboratory tests results', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'uraemia'}, {'measure': 'Incidence of abnormal laboratory tests results', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'serum creatinine'}, {'measure': 'Incidence of abnormal laboratory tests results', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'leptin'}, {'measure': 'anthropometric measures', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'height'}, {'measure': 'anthropometric measures', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'weight'}, {'measure': 'anthropometric measures', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'body mass index'}, {'measure': 'anthropometric measures', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'waist circumference'}, {'measure': 'anthropometric measures', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'estimation of fat mass'}, {'measure': 'anthropometric measures', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'estimation of skeletal muscle mass'}, {'measure': 'anthropometric measures', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed at the 6th and 12 months', 'description': 'estimation of grade of visceral fat'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diet, Healthy', 'Obesity', 'Olfaction Disorders']}, 'referencesModule': {'references': [{'pmid': '22387713', 'type': 'BACKGROUND', 'citation': 'Cameron JD, Goldfield GS, Doucet E. Fasting for 24 h improves nasal chemosensory performance and food palatability in a related manner. Appetite. 2012 Jun;58(3):978-81. doi: 10.1016/j.appet.2012.02.050. Epub 2012 Mar 2.'}, {'pmid': '22832483', 'type': 'BACKGROUND', 'citation': 'Palouzier-Paulignan B, Lacroix MC, Aime P, Baly C, Caillol M, Congar P, Julliard AK, Tucker K, Fadool DA. Olfaction under metabolic influences. Chem Senses. 2012 Nov;37(9):769-97. doi: 10.1093/chemse/bjs059. Epub 2012 Jul 25.'}, {'pmid': '4670856', 'type': 'BACKGROUND', 'citation': 'Pager J, Giachetti I, Holley A, Le Magnen J. A selective control of olfactory bulb electrical activity in relation to food deprivation and satiety in rats. Physiol Behav. 1972 Oct;9(4):573-9. doi: 10.1016/0031-9384(72)90014-5. No abstract available.'}, {'pmid': '21490225', 'type': 'BACKGROUND', 'citation': "Tong J, Mannea E, Aime P, Pfluger PT, Yi CX, Castaneda TR, Davis HW, Ren X, Pixley S, Benoit S, Julliard K, Woods SC, Horvath TL, Sleeman MM, D'Alessio D, Obici S, Frank R, Tschop MH. Ghrelin enhances olfactory sensitivity and exploratory sniffing in rodents and humans. J Neurosci. 2011 Apr 13;31(15):5841-6. doi: 10.1523/JNEUROSCI.5680-10.2011."}, {'pmid': '11289032', 'type': 'BACKGROUND', 'citation': 'Tschop M, Weyer C, Tataranni PA, Devanarayan V, Ravussin E, Heiman ML. Circulating ghrelin levels are decreased in human obesity. Diabetes. 2001 Apr;50(4):707-9. doi: 10.2337/diabetes.50.4.707.'}, {'pmid': '12050284', 'type': 'BACKGROUND', 'citation': 'English PJ, Ghatei MA, Malik IA, Bloom SR, Wilding JP. Food fails to suppress ghrelin levels in obese humans. J Clin Endocrinol Metab. 2002 Jun;87(6):2984. doi: 10.1210/jcem.87.6.8738.'}, {'pmid': '24582673', 'type': 'BACKGROUND', 'citation': 'Meyer-Gerspach AC, Wolnerhanssen B, Beglinger B, Nessenius F, Napitupulu M, Schulte FH, Steinert RE, Beglinger C. Gastric and intestinal satiation in obese and normal weight healthy people. Physiol Behav. 2014 Apr 22;129:265-71. doi: 10.1016/j.physbeh.2014.02.043. Epub 2014 Feb 28.'}, {'pmid': '20978137', 'type': 'BACKGROUND', 'citation': 'Stafford LD, Welbeck K. High hunger state increases olfactory sensitivity to neutral but not food odors. Chem Senses. 2011 Jan;36(2):189-98. doi: 10.1093/chemse/bjq114. Epub 2010 Oct 26.'}, {'pmid': '24760977', 'type': 'BACKGROUND', 'citation': 'Goldstone AP, Prechtl CG, Scholtz S, Miras AD, Chhina N, Durighel G, Deliran SS, Beckmann C, Ghatei MA, Ashby DR, Waldman AD, Gaylinn BD, Thorner MO, Frost GS, Bloom SR, Bell JD. Ghrelin mimics fasting to enhance human hedonic, orbitofrontal cortex, and hippocampal responses to food. Am J Clin Nutr. 2014 Jun;99(6):1319-30. doi: 10.3945/ajcn.113.075291. Epub 2014 Apr 23.'}, {'pmid': '28202779', 'type': 'BACKGROUND', 'citation': 'Wei M, Brandhorst S, Shelehchi M, Mirzaei H, Cheng CW, Budniak J, Groshen S, Mack WJ, Guen E, Di Biase S, Cohen P, Morgan TE, Dorff T, Hong K, Michalsen A, Laviano A, Longo VD. Fasting-mimicking diet and markers/risk factors for aging, diabetes, cancer, and cardiovascular disease. Sci Transl Med. 2017 Feb 15;9(377):eaai8700. doi: 10.1126/scitranslmed.aai8700.'}, {'pmid': '39970875', 'type': 'DERIVED', 'citation': 'Micarelli A, Mrakic-Sposta S, Vezzoli A, Malacrida S, Caputo S, Micarelli B, Misici I, Carbini V, Iennaco I, Granito I, Longo VD, Alessandrini M. Chemosensory and cardiometabolic improvements after a fasting-mimicking diet: A randomized cross-over clinical trial. Cell Rep Med. 2025 Feb 18;6(2):101971. doi: 10.1016/j.xcrm.2025.101971.'}]}, 'descriptionModule': {'briefSummary': 'Literature experiences demonstrated the impact of medically-assisted pulsed fasting on olfactory behavior in both the animal and human models and - conversely - the lack of homogeneous results linked - up to now - to administrations of pulsed fasting which are not widely codified.\n\nThus, objective of this study protocol is to evaluate the olfactory-gustatory aspects and blood patterns of a group of subjects suffering from obesity / overweight after a 6-month period of Fasting Mimicking Diet (FMD) (Group A) - consisting of a caloric restriction regimen - compared to a group of homogeneous subjects observing their own eating habits (Group B) which - according to a "cross-over" model - will undergo FMD in the following semester during which the subjects belonging to Group A will observe their eating habits.', 'detailedDescription': "A group of obese and/or overweighted patients who did not pass screening criteria (BMI andor neuropsychological testing) to undergo surgical procedure aimed at reducing weight (grastrectomy, bypass, other…) will follow a 6-month period of FMD followed by 6-month period of routinary eating behaviour (Group A) or viceversa (Group B).\n\nAll the patients will undergo - before and after the administration of FMD or the routinary diet habit - a battery of:\n\n* Olfactory test (sniffin' stick test)\n* Taste Test (Taste strips)\n* Blood Samples including: IGF-1, IGFBP1/3, VEGF, insulin, adiponectin, c reactive protein, plasma ghrelin, serum glucose, alanine aminotransferase (ALT) and aspartate aminotransferase (AST), total cholesterol, triglycerides (TGs), high density lipoprotein (HDL) cholesterol and low-density lipoprotein (LDL) cholesterol, erythrocyte sedimentation rate (ESR), conjugated and unconjugated bilirubin, uraemia, serum creatinine and leptin.\n* anthropometeric measures, including height and body weight, BMI, waist circumference (WC), estimation of fat mass (FM, in % and Kg), skeletal muscle mass (MM, in % and Kg) and grade of visceral fat (VF level)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects excluded from bariatric surgical treatment for failing to neuropsychological tests or for co-morbidities that would excessively increase the intra-operative and/or\n* non-responders to any previous dietary / nutritional treatment\n* BMI \\> 25\n\nExclusion Criteria:\n\n* Subjects under the age of 18 and over 75 years.\n* Subjects already undergoing bariatric surgical treatment\n* Women who are pregnant or breastfeeding\n* Hormonal therapies and / or chemotherapy in place\n* Active mental or psychiatric illness\n* Addiction to drugs of abuse or alcohol\n* other acute or chronic systemic disorders\n* Severe hypertension (systolic blood pressure\\> 200 mm Hg and / or diastolic blood pressure\\> 105 mm Hg)\n* Visual impairment (for completion of neuropsychological tests)\n* Inability to complete home FMD'}, 'identificationModule': {'nctId': 'NCT04529161', 'acronym': 'FMD1', 'briefTitle': 'Olfactory and Taste Changes During Fasting Mimicking Diet (FMD)', 'organization': {'class': 'OTHER', 'fullName': 'Uniter Onlus'}, 'officialTitle': 'Changes in Olfactory and Taste Behavior in Overweight / Obese Subjects Undergoing Fasting Mimicking Diet (FMD)', 'orgStudyIdInfo': {'id': 'UniterFMD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Diet followed by routine eating', 'interventionNames': ['Dietary Supplement: Fasting Mimicking Diet (FMD)', 'Dietary Supplement: Routinary diet habits']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Routine eating followed by diet', 'interventionNames': ['Dietary Supplement: Fasting Mimicking Diet (FMD)', 'Dietary Supplement: Routinary diet habits']}], 'interventions': [{'name': 'Fasting Mimicking Diet (FMD)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The treatment consists in the self-administration of FMD at home - closely followed by the neuropsychologist by phone and by a properly trained nutritionist in the FMD sector - for 5 days a month for 6 consecutive months.', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'Routinary diet habits', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects will follow their routinary eating habits for 6 consecutive months', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00012', 'city': 'Roma', 'state': 'Rome', 'country': 'Italy', 'facility': 'University of Rome Tor Vergata - UNITER Onlus', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Marco Alessandrini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rome Tor Vergata'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uniter Onlus', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Rome Tor Vergata', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}