Status:
COMPLETED
Olfactory and Taste Changes During Fasting Mimicking Diet (FMD)
Lead Sponsor:
Uniter Onlus
Collaborating Sponsors:
University of Rome Tor Vergata
Conditions:
Diet, Healthy
Obesity
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ...
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, o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2022
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04529161
Start Date
October 1 2020
End Date
October 30 2022
Last Update
March 12 2024
Active Locations (1)
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1
University of Rome Tor Vergata - UNITER Onlus
Roma, Rome, Italy, 00012