Diet, HealthyFMD1NCT04529161
Olfactory and Taste Changes During Fasting Mimicking Diet (FMD)
A study testing Fasting Mimicking Diet (FMD) and Routinary diet habits in people with Diet, Healthy and Obesity, run by Uniter Onlus at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diet, Healthy, Obesity, Olfaction Disorders
- What is being tested?
- Fasting Mimicking Diet (FMD) and Routinary diet habits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2020to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Conditions
- Diet, Healthy, Obesity, Olfaction Disorders
- Being tested
- Fasting Mimicking Diet (FMD), Routinary diet habits
- Medical subject headings
- Obesity, Olfaction Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Routinary diet habitsDietary supplement
Subjects will follow their routinary eating habits for 6 consecutive months
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Diet followed by routine eating Receives: Dietary Supplement: Fasting Mimicking Diet (FMD); Dietary Supplement: Routinary diet habits |
| Group B | Experimental | Routine eating followed by diet Receives: Dietary Supplement: Fasting Mimicking Diet (FMD); Dietary Supplement: Routinary diet habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sniffing stick test change
Quantitative screening of olfactory performance
Measured: 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
Measured: 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
serum glucose
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Serum/plasma growth factors: IGF-1
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Serum/plasma growth factors: IGFBP1/3
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Serum/plasma growth factors: insulin
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Serum/plasma growth factors: VEGF
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
plasma ghrelin.
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Serum/plasma inflammatory markers: adiponectin
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
Serum/plasma inflammatory markers: c reactive protein
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
alanine aminotransferase
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
aspartate aminotransferase
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
total cholesterol
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
triglycerides
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
high density lipoprotein cholesterol
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
low-density lipoprotein cholesterol
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
erythrocyte sedimentation rate
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
conjugated and unconjugated bilirubin
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
uraemia
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
serum creatinine
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Incidence of abnormal laboratory tests results
leptin
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
anthropometric measures
height
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
anthropometric measures
weight
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
anthropometric measures
body mass index
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
anthropometric measures
waist circumference
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
anthropometric measures
estimation of fat mass
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
anthropometric measures
estimation of skeletal muscle mass
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
anthropometric measures
estimation of grade of visceral fat
Measured: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Oct 2020
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will follow a 6-months period of FMD followed by a 6-months of routinary eating habits (Group A) or viceversa (Group B)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniter Onlus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rome Tor Vergata
- Responsible party
- Sponsor
- Investigators
- Marco Alessandrini, MD, Principal investigator, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529161
- Sponsor's protocol ID
- UniterFMD
- Acronym
- FMD1
- Status last verified
- Mar 2024
- First submitted
- 18 Aug 2020
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22387713Palouzier-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.
PubMed 22832483Pager 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.
PubMed 4670856Tong 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.
PubMed 21490225Tschop 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.
PubMed 11289032English 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.
PubMed 12050284Meyer-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.
PubMed 24582673Stafford 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.
PubMed 20978137Goldstone 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.
PubMed 24760977Wei 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.
PubMed 28202779Micarelli 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.
PubMed 39970875
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Olfactory and Taste Behavior in Overweight / Obese Subjects Undergoing Fasting Mimicking Diet (FMD)
- ClinicalTrials.gov ID
- NCT04529161
- Acronym / sponsor ID
- FMD1 / UniterFMD
- Conditions
- Diet, Healthy, Obesity, Olfaction Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Uniter OnlusUniversity, hospital or other
- Collaborators
- University of Rome Tor Vergata
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will follow a 6-months period of FMD followed by a 6-months of routinary eating habits (Group A) or viceversa (Group B)
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Dietary Supplement: Fasting Mimicking Diet (FMD), Dietary Supplement: Routinary diet habitsDiet followed by routine eating |
| Group B | Experimental | Dietary Supplement: Fasting Mimicking Diet (FMD), Dietary Supplement: Routinary diet habitsRoutine eating followed by diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Group A, Group B |
| Routinary diet habitsSubjects will follow their routinary eating habits for 6 consecutive months | Dietary supplement | Group A, Group B |
Primary outcome
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
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
26 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
anthropometric measures
Time frame: 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
anthropometric measures
Time frame: 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
anthropometric measures
Time frame: 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
anthropometric measures
Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 22387713Cameron 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.
- Background: PubMed 22832483Palouzier-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.
- Background: PubMed 4670856Pager 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.
- Background: PubMed 21490225Tong 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.
- Background: PubMed 11289032Tschop 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.
- Background: PubMed 12050284English 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.
- Background: PubMed 24582673Meyer-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.
- Background: PubMed 20978137Stafford 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.
- Background: PubMed 24760977Goldstone 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.
- Background: PubMed 28202779Wei 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.
- Derived from this study: PubMed 39970875Micarelli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Alessandrini, MD principal investigator
University of Rome Tor Vergata
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting Mimicking Diet (FMD) and Routinary diet habits in people with Diet, Healthy and Obesity, run by Uniter Onlus at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sniffing stick test change (time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04529161, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024; AzTrials last refreshed its copy on 1 Nov 2026.