Olfactory Changes During Fasting Mimicking Diet (FMD)

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Olfactory test (sniffin' stick test) Taste Test (Taste strips) Blood Samples including: IGF-1, IGFBP1/3, VEGF, insulin, adiponectin, c reactive protein, plasma ghrelin

Official Title
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Changes in Olfactory Behavior in Overweight / Obese Subjects Undergoing Fasting Mimicking Diet (FMD)

Conditions
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Diet, Healthy, Obesity, Olfaction Disorders

Intervention / Treatment
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* Dietary Supplement: Fasting Mimicking Diet (FMD)
* Dietary Supplement: Routinary diet habits


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects excluded from bariatric surgical treatment for failing to neuropsychological tests or for co-morbidities that would excessively increase the intra-operative and/or non-responders to any previous dietary / nutritional treatment Exclusion Criteria: Subjects under the age of 18 and over 70 years. Subjects already undergoing bariatric surgical treatment Women who are pregnant or breastfeeding Hormonal therapies and / or chemotherapy in place Active mental or psychiatric illness Addiction to drugs of abuse or alcohol Severe hypertension (systolic blood pressure> 200 mm Hg and / or diastolic blood pressure> 105 mm Hg) Visual impairment (for completion of neuropsychological tests) Inability to complete home FMD

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients will follow a 6-months period of FMD followed by a 6-months of routinary eating habits (Group A) or viceversa (Group B)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Diet followed by routine eating | Dietary Supplement: Fasting Mimicking Diet (FMD)<br>* 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.<br>Dietary Supplement: Routinary diet habits<br>* Subjects will follow their routinary eating habits for 6 consecutive months<br>|
| Experimental: Group B<br>Routine eating followed by diet | Dietary Supplement: Fasting Mimicking Diet (FMD)<br>* 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.<br>Dietary Supplement: Routinary diet habits<br>* Subjects will follow their routinary eating habits for 6 consecutive months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sniffing stick test change | Quantitative screening of olfactory performance | Change from baseline olfactory detection at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Incidence of abnormal laboratory tests results | 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 |