Olfactory and Taste Changes During Fasting Mimicking Diet (FMD)

Not Applicable

Completed

• Conditions: Olfaction Disorders; Diet, Healthy; Obesity
• Interventions: Dietary Supplement: Fasting Mimicking Diet (FMD); Dietary Supplement: Routinary diet habits

• Registration Number: NCT04529161
• Lead Sponsor: Uniter Onlus

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)

Study Timeline

• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-27
• Study Start: 2020-10-01
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	Fasting Mimicking Diet (FMD)	Diet followed by routine eating
Group A	Routinary diet habits	Diet followed by routine eating
Group B	Fasting Mimicking Diet (FMD)	Routine eating followed by diet
Group B	Routinary diet habits	Routine eating followed by diet

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of abnormal laboratory tests results	From date of randomization until the date of first documented progression, assessed at the 6th and 12 months	leptin
anthropometric measures	From date of randomization until the date of first documented progression, assessed at the 6th and 12 months	estimation of grade of visceral fat

Trial Locations

Locations (1)

University of Rome Tor Vergata - UNITER Onlus; 🇮🇹 Roma, Rome, Italy