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:
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 102 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Uniter Onlus is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from Oct 2020 to primary completion in Oct 2022, 24 months.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 24 months is close to that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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