NCT04529161

Olfactory and Taste Changes During Fasting Mimicking Diet (FMD)

Changes in Olfactory and Taste Behavior in Overweight / Obese Subjects Undergoing Fasting Mimicking Diet (FMD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Uniter Onlus · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Diet, Healthy
• Obesity
• Olfaction Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fasting 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_SUPPLEMENT	Routinary diet habits	Subjects will follow their routinary eating habits for 6 consecutive months

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-10-30
• Completion: 2022-10-30
• First posted: 2020-08-27
• Last updated: 2024-03-12

Locations

1 site across 1 country: Italy