An interventional study of Fasting Mimicking Diet (FMD) and Routinary diet habits in Diet, Healthy, Obesity and Olfaction Disorders, sponsored by Uniter Onlus. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by Uniter Onlus · Not applicable, Interventional, and Supportive care
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:
Exclusion Criteria:
Diet followed by routine eating
Dietary Supplement: Fasting Mimicking Diet (FMD) · Dietary Supplement: Routinary diet habits
Routine eating followed by diet
Dietary Supplement: Fasting Mimicking Diet (FMD) · Dietary Supplement: Routinary diet habits
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.
Subjects will follow their routinary eating habits for 6 consecutive months
Sniffing stick test change
Quantitative screening of olfactory performance
Time frame: 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
Time frame: 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 glucose
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
anthropometric measures
height
Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
anthropometric measures
weight
Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
anthropometric measures
body mass index
Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
anthropometric measures
waist circumference
Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
anthropometric measures
estimation of fat mass
Time frame: 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
Time frame: 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
Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
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