Diet, Healthy, Obesity, Olfaction Disorders
Conditions
Brief summary
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
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, 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. * 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)
Interventions
DIETARY_SUPPLEMENTFasting Mimicking Diet (FMD)
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.
DIETARY_SUPPLEMENTRoutinary diet habits
Subjects will follow their routinary eating habits for 6 consecutive months
Sponsors
University of Rome Tor Vergata
Uniter Onlus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 * BMI \> 25
Exclusion criteria
* Subjects under the age of 18 and over 75 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 * other acute or chronic systemic disorders * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sniffing stick test change | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months | Quantitative screening of olfactory performance |
| Taste Strips | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months | Quantitative assessment of taste performance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| anthropometric measures | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months | height |
| Incidence of abnormal laboratory tests results | From date of randomization until the date of first documented progression, assessed at the 6th and 12 months | serum glucose |
Countries
Italy
Outcome results
None listed