Olfactory and Taste Changes During Fasting Mimicking Diet (FMD) (FMD1)

March 7, 2024 updated by: Uniter Onlus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Rome
      • Roma, Rome, Italy, 00012
        • University of Rome Tor Vergata - UNITER Onlus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Diet followed by routine eating
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
Experimental: Group B
Routine eating followed by diet
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Taste Strips
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Quantitative assessment of taste performance
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Sniffing stick test change
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Quantitative screening of olfactory performance
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of abnormal laboratory tests results
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Serum/plasma growth factors: IGF-1
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Serum/plasma growth factors: IGFBP1/3
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Serum/plasma growth factors: insulin
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Serum/plasma growth factors: VEGF
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
plasma ghrelin.
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Serum/plasma inflammatory markers: adiponectin
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Serum/plasma inflammatory markers: c reactive protein
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
serum glucose
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
alanine aminotransferase
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
aspartate aminotransferase
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
total cholesterol
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
triglycerides
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
high density lipoprotein cholesterol
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
low-density lipoprotein cholesterol
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
erythrocyte sedimentation rate
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
conjugated and unconjugated bilirubin
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
uraemia
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
serum creatinine
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
leptin
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
anthropometric measures
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
height
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
anthropometric measures
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
weight
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
anthropometric measures
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
body mass index
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
anthropometric measures
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
waist circumference
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
anthropometric measures
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
estimation of fat mass
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
anthropometric measures
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
estimation of skeletal muscle mass
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
anthropometric measures
Time Frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
estimation of grade of visceral fat
From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uniter Onlus

Collaborators

University of Rome Tor Vergata

Investigators

  • Principal Investigator: Marco Alessandrini, MD, University of Rome Tor Vergata

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

October 30, 2022

Study Completion (Actual)

October 30, 2022

Study Registration Dates

First Submitted

August 18, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

August 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UniterFMD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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