Olfactory and Taste Changes During Fasting Mimicking Diet (FMD)

NCT04529161 | Completed

• 1 other identifier: UniterFMD
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet, Healthy; Obesity; Olfaction Disorders

Outcome Measures

Primary Outcomes (2)

• Sniffing stick test change

  Quantitative screening of olfactory performance

  From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

• Taste Strips

  Quantitative assessment of taste performance

  From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

Secondary Outcomes (26)

• Incidence of abnormal laboratory tests results

  From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

• Incidence of abnormal laboratory tests results

  From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

• Incidence of abnormal laboratory tests results

  From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

• Incidence of abnormal laboratory tests results

  From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

• Incidence of abnormal laboratory tests results

  From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

Study Arms (2)

Group A

EXPERIMENTAL

Diet followed by routine eating

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

Group B

EXPERIMENTAL

Routine eating followed by diet

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

Interventions

Fasting Mimicking Diet (FMD) DIETARY_SUPPLEMENT

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.

Group A; Group B

Routinary diet habits DIETARY_SUPPLEMENT

Subjects will follow their routinary eating habits for 6 consecutive months

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uniter Onlus: lead
• University of Rome Tor Vergata: collaborator

Study Sites (1)

University of Rome Tor Vergata - UNITER Onlus

Roma, Rome, 00012, Italy

Location

Related Publications (11)

• Cameron JD, Goldfield GS, Doucet E. Fasting for 24 h improves nasal chemosensory performance and food palatability in a related manner. Appetite. 2012 Jun;58(3):978-81. doi: 10.1016/j.appet.2012.02.050. Epub 2012 Mar 2.

  PMID: 22387713 BACKGROUND

• Palouzier-Paulignan B, Lacroix MC, Aime P, Baly C, Caillol M, Congar P, Julliard AK, Tucker K, Fadool DA. Olfaction under metabolic influences. Chem Senses. 2012 Nov;37(9):769-97. doi: 10.1093/chemse/bjs059. Epub 2012 Jul 25.

  PMID: 22832483 BACKGROUND

• Pager J, Giachetti I, Holley A, Le Magnen J. A selective control of olfactory bulb electrical activity in relation to food deprivation and satiety in rats. Physiol Behav. 1972 Oct;9(4):573-9. doi: 10.1016/0031-9384(72)90014-5. No abstract available.

  PMID: 4670856 BACKGROUND

• Tong J, Mannea E, Aime P, Pfluger PT, Yi CX, Castaneda TR, Davis HW, Ren X, Pixley S, Benoit S, Julliard K, Woods SC, Horvath TL, Sleeman MM, D'Alessio D, Obici S, Frank R, Tschop MH. Ghrelin enhances olfactory sensitivity and exploratory sniffing in rodents and humans. J Neurosci. 2011 Apr 13;31(15):5841-6. doi: 10.1523/JNEUROSCI.5680-10.2011.

  PMID: 21490225 BACKGROUND

• Tschop M, Weyer C, Tataranni PA, Devanarayan V, Ravussin E, Heiman ML. Circulating ghrelin levels are decreased in human obesity. Diabetes. 2001 Apr;50(4):707-9. doi: 10.2337/diabetes.50.4.707.

  PMID: 11289032 BACKGROUND

• English PJ, Ghatei MA, Malik IA, Bloom SR, Wilding JP. Food fails to suppress ghrelin levels in obese humans. J Clin Endocrinol Metab. 2002 Jun;87(6):2984. doi: 10.1210/jcem.87.6.8738.

  PMID: 12050284 BACKGROUND

• Meyer-Gerspach AC, Wolnerhanssen B, Beglinger B, Nessenius F, Napitupulu M, Schulte FH, Steinert RE, Beglinger C. Gastric and intestinal satiation in obese and normal weight healthy people. Physiol Behav. 2014 Apr 22;129:265-71. doi: 10.1016/j.physbeh.2014.02.043. Epub 2014 Feb 28.

  PMID: 24582673 BACKGROUND

• Stafford LD, Welbeck K. High hunger state increases olfactory sensitivity to neutral but not food odors. Chem Senses. 2011 Jan;36(2):189-98. doi: 10.1093/chemse/bjq114. Epub 2010 Oct 26.

  PMID: 20978137 BACKGROUND

• Goldstone AP, Prechtl CG, Scholtz S, Miras AD, Chhina N, Durighel G, Deliran SS, Beckmann C, Ghatei MA, Ashby DR, Waldman AD, Gaylinn BD, Thorner MO, Frost GS, Bloom SR, Bell JD. Ghrelin mimics fasting to enhance human hedonic, orbitofrontal cortex, and hippocampal responses to food. Am J Clin Nutr. 2014 Jun;99(6):1319-30. doi: 10.3945/ajcn.113.075291. Epub 2014 Apr 23.

  PMID: 24760977 BACKGROUND

• Wei M, Brandhorst S, Shelehchi M, Mirzaei H, Cheng CW, Budniak J, Groshen S, Mack WJ, Guen E, Di Biase S, Cohen P, Morgan TE, Dorff T, Hong K, Michalsen A, Laviano A, Longo VD. Fasting-mimicking diet and markers/risk factors for aging, diabetes, cancer, and cardiovascular disease. Sci Transl Med. 2017 Feb 15;9(377):eaai8700. doi: 10.1126/scitranslmed.aai8700.

  PMID: 28202779 BACKGROUND

• Micarelli A, Mrakic-Sposta S, Vezzoli A, Malacrida S, Caputo S, Micarelli B, Misici I, Carbini V, Iennaco I, Granito I, Longo VD, Alessandrini M. Chemosensory and cardiometabolic improvements after a fasting-mimicking diet: A randomized cross-over clinical trial. Cell Rep Med. 2025 Feb 18;6(2):101971. doi: 10.1016/j.xcrm.2025.101971.

  PMID: 39970875 DERIVED

MeSH Terms

Conditions

Obesity; Olfaction Disorders

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases

Study Officials

• Marco Alessandrini, MD

  University of Rome Tor Vergata

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will follow a 6-months period of FMD followed by a 6-months of routinary eating habits (Group A) or viceversa (Group B)

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 27, 2020
• Study Start: October 1, 2020
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

IT (1)