Olfactory and Taste Changes During Fasting Mimicking Diet (FMD)

Obesity Clinical Trial

— FMD1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04529161
• Other study ID #: UniterFMD
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: October 30, 2022

Study information

• Verified date: March 2024
• Source: Uniter Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet, Healthy
• Obesity
• Olfaction Disorders

Intervention

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.
• Routinary diet habits
Subjects will follow their routinary eating habits for 6 consecutive months

Locations

Country	Name	City	State
Italy	University of Rome Tor Vergata - UNITER Onlus	Roma	Rome

Sponsors (2)

Lead Sponsor	Collaborator
Uniter Onlus	University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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