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| Name | Class |
|---|---|
| University of Rome Tor Vergata | OTHER |
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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.
Thus, 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.
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).
All the patients will undergo - before and after the administration of FMD or the routinary diet habit - a battery of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Diet followed by routine eating |
|
| Group B | Experimental | Routine eating followed by diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting Mimicking Diet (FMD) | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sniffing stick test change | Quantitative screening of olfactory performance | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| Taste Strips | Quantitative assessment of taste performance | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of abnormal laboratory tests results | serum glucose | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| Incidence of abnormal laboratory tests results |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Alessandrini, MD | University of Rome Tor Vergata | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rome Tor Vergata - UNITER Onlus | Roma | Rome | 00012 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22387713 | Background | 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. | |
| 22832483 | Background | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D000857 | Olfaction Disorders |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Patients will follow a 6-months period of FMD followed by a 6-months of routinary eating habits (Group A) or viceversa (Group B)
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| Routinary diet habits | Dietary Supplement | Subjects will follow their routinary eating habits for 6 consecutive months |
|
Serum/plasma growth factors: IGF-1
| From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| Incidence of abnormal laboratory tests results | Serum/plasma growth factors: IGFBP1/3 | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| Incidence of abnormal laboratory tests results | Serum/plasma growth factors: insulin | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| Incidence of abnormal laboratory tests results | Serum/plasma growth factors: VEGF | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| Incidence of abnormal laboratory tests results | plasma ghrelin. | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| Incidence of abnormal laboratory tests results | Serum/plasma inflammatory markers: adiponectin | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| Incidence of abnormal laboratory tests results | Serum/plasma inflammatory markers: c reactive protein | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| Incidence of abnormal laboratory tests results | alanine aminotransferase | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| Incidence of abnormal laboratory tests results | aspartate aminotransferase | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| Incidence of abnormal laboratory tests results | total cholesterol | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| Incidence of abnormal laboratory tests results | triglycerides | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| Incidence of abnormal laboratory tests results | high density lipoprotein cholesterol | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| Incidence of abnormal laboratory tests results | low-density lipoprotein cholesterol | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| Incidence of abnormal laboratory tests results | erythrocyte sedimentation rate | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| Incidence of abnormal laboratory tests results | conjugated and unconjugated bilirubin | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| Incidence of abnormal laboratory tests results | uraemia | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| Incidence of abnormal laboratory tests results | serum creatinine | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| Incidence of abnormal laboratory tests results | leptin | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| anthropometric measures | height | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| anthropometric measures | weight | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| anthropometric measures | body mass index | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| anthropometric measures | waist circumference | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| anthropometric measures | estimation of fat mass | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| anthropometric measures | estimation of skeletal muscle mass | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| anthropometric measures | estimation of grade of visceral fat | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months |
| 4670856 | Background | 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. |
| 21490225 | Background | 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. |
| 11289032 | Background | 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. |
| 12050284 | Background | 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. |
| 24582673 | Background | 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. |
| 20978137 | Background | 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. |
| 24760977 | Background | 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. |
| 28202779 | Background | 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. |
| 39970875 | Derived | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |