Olfactory and Taste Changes During Fasting Mimicking Diet (FMD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-10-30

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.

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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, 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

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Diet, Healthy Obesity Olfaction Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Patients will follow a 6-months period of FMD followed by a 6-months of routinary eating habits (Group A) or viceversa (Group B)

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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