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Olfactory and Taste Changes During Fasting Mimicking Diet (FMD)

NCT04529161 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2024-03-12

No results posted yet for this study

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.

Conditions

  • Diet, Healthy
  • Obesity
  • Olfaction Disorders

Interventions

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

Sponsors & Collaborators

  • University of Rome Tor Vergata

    collaborator OTHER

  • Uniter Onlus

    lead OTHER

Principal Investigators

  • Marco Alessandrini, MD · University of Rome Tor Vergata

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-10-30
Completion
2022-10-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04529161 on ClinicalTrials.gov