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

Uniter Onlus

Status: Completed

Conditions: Olfaction Disorders; Obesity; Diet, Healthy

Treatments: Dietary Supplement: Fasting Mimicking Diet (FMD); Dietary Supplement: Routinary diet habits

Study type: Interventional

Funder types: Other

Identifiers

NCT04529161

UniterFMD

Details and patient eligibility

About

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.

Full 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)

Enrollment: 102 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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102 participants in 2 patient groups

Group A

Experimental group

Description:

Diet followed by routine eating

Treatment:

Dietary Supplement: Fasting Mimicking Diet (FMD)

Dietary Supplement: Routinary diet habits

Group B

Experimental group

Description:

Routine eating followed by diet

Treatment:

Dietary Supplement: Fasting Mimicking Diet (FMD)

Dietary Supplement: Routinary diet habits