OverweightNCT07065955

Longevity Diet and the Fasting-mimicking Diet

An observational study of Overweight and Obesity, run by Fondazione Valter Longo at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Overweight, Obesity, Metabolic Syndrome
What is being tested?: Longevity diet alone or in combination with fasting mimicking diet
How many people: 365 participants
Where: 1 siteItaly
Study dates: 1 Jan 2019to 1 Mar 2024
Phase: Observational
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The bioimpedance, anthropometric, and clinical data of subjects who underwent at least one of the two nutritional interventions (individually or in combination) at the Valter Longo Foundation in Milan from 2019 to 2024 will be retrospectively analyzed. As this is a purely observational (retrospective) study with purely descriptive objectives, a formal power analysis estimation has not been conducted. However, considering that the Valter Longo Foundation in Milan is a regional reference point, it is estimated that approximately 250 subjects will be recruited retrospectively.

Who may be able to join

Healthy patients and/or those with diseases, excluding neoplastic and neurodegenerative pathologies;
Age >/= 18 years;
Body mass index >/= 18.5 kg/m2;
At least two visits, both characterized by bioimpedance and anthropometric analysis;
At least 3 months between the first and last bioimpedance and anthropometric analysis;
Signature of informed consent and privacy for the conducted visits.

Who cannot join

Age < 18 years;
Lack of informed consent or privacy;
Women who are pregnant or breastfeeding;
Patients affected by oncological and/or neurodegenerative pathologies.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Fondazione Valter Longo Onlus
Milan, 20122

Other trials in Italy

About this study

Official title: Effects of the Longevity Diet and the Fasting-mimicking Diet on Body Composition, Risk Factors for Age-related Diseases

This retrospective clinical study examines the impact of the longevity diet and fasting-mimicking diet (FMD), either alone or combined, on body composition and health indicators. Focused on subjects from the Valter Longo Foundation (2019-2024), the study aims to evaluate their effects on body fat percentage, lean mass, muscle function, and lipid profiles.

The longevity diet, rooted in centenarian dietary traditions, emphasizes isocaloric meals with a balance of complex carbohydrates, unsaturated fats, and plant-based proteins. FMD involves a 5-day highly hypocaloric vegan diet to simulate fasting benefits. Hypothesizing that a return to a modified Mediterranean diet or incorporating FMD could improve overall health, the study spans diverse cohorts based on intervention type, duration, obesity level, and physio-pathological status.

Data, collected from electronic medical records, will undergo statistical analyses to compare pre- and post-intervention measurements, exploring outcomes across subgroups. Ethical considerations, including de-identified data and informed consent, ensure compliance with clinical research regulations.

In conclusion, this study provides valuable insights into the potential health and longevity benefits of the longevity diet and FMD, with implications for public wellness.

Read the detailed description

Introduction Aging is often accompanied by numerous chronic degenerative conditions that compromise the quality of life and lead to dependency. However, a favorable interaction between genetic and environmental factors could lead to a significantly higher life expectancy, free from conditions that significantly compromise both the quality and duration of life, highlighting that increased longevity is not necessarily accompanied by one or more pathological conditions. It is widely accepted that the quality and quantity of nutrition are essential factors in maintaining health and preventing diseases. Making healthy and conscious dietary choices can indeed alter the course of life in terms of both duration and health. Numerous epidemiological studies have demonstrated the critical role of a proper dietary regimen in the risk of developing age-related diseases. Furthermore, recent studies have highlighted how short periods of extreme calorie reduction with adequate nutrient intake (5 days, fasting-mimicking diet, FMD) can impact metabolism, producing numerous beneficial effects in both healthy individuals and those with chronic degenerative conditions such as cancer, cardiovascular diseases, diabetes, and autoimmune diseases. Theories about senescence usually focus on the aging process and not on the ability of organisms to stay young. The longevity diet proposed in this study is intended to be effective in achieving the goal of extending youth for as long as possible, optimizing protection, regeneration, and rejuvenation while minimizing diseases. It is based on five pillars that support the scientific evidence of the program: basic research, epidemiology, clinical studies, centenarian studies, and complex systems studies. Essentially, the longevity diet incorporates the dietary tradition of healthy centenarians, characterized by simplicity and products typical of their region of origin. This type of diet generally consists of three isocaloric meals and one snack (for normal-weight individuals) or slightly hypocaloric meals (in the case of overweight or obesity). The diet consists of 50-60% of calories from complex carbohydrates, 30-35% of calories from mostly unsaturated fats, and 10-11% of calories from proteins, primarily from plant sources and fish, and occasionally from eggs, dairy, and meat, especially for those over 65. The diet is formulated to provide all necessary nutrients, including vitamins and minerals. The fasting-mimicking diet is a dietary intervention in which normal food is replaced with a standardized, highly hypocaloric vegan diet for a limited period of 5 consecutive days. This diet is designed to stimulate the same processes normally activated during fasting while minimizing the side effects of total food deprivation. This retrospective clinical study aims to investigate the two different approaches: the longevity diet and the fasting-mimicking diet, to assess both their feasibility and effectiveness when used individually or in combination. 1.1 Background and Hypotheses The Italian population has moved away from the traditional Mediterranean diet and now predominantly follows a Western-style diet that is hypercaloric, rich in saturated fats, animal protein, and sugars. We hypothesize that a return to the original Mediterranean diet with modifications based on the scientific evidence of recent decades (longevity diet), and/or short periods of fasting-mimicking diet (5 days), can improve the overall health conditions of the population.
Objectives and Purpose of the Study Primary Objective: To evaluate whether the longevity diet and the fasting-mimicking diet, either individually or in combination, can reduce the percentage of body fat in a cohort of subjects stratified by gender, age, body mass index, and defined physio-pathological states. Secondary Objectives: To assess whether the longevity diet and the fasting-mimicking diet, either individually or in combination, can positively influence parameters related to the general health status of the analyzed sample, including (i) percentage of lean mass, (ii) phase angle as an indirect indicator of muscle function and cellular integrity, (iii) waist and hip circumference, (iv) total cholesterol, HDL, and LDL.
Study Design This is a retrospective, observational, single-center study to evaluate the effect of specific nutritional interventions (fasting-mimicking diet (FMD) and longevity diet (LD)) on reducing body fat. To achieve this, retrospective data from bioimpedance, anthropometric, and clinical analyses of subjects who underwent at least one of the two nutritional interventions (individually or in combination) at the Valter Longo Foundation in Milan from 2019 to 2024 will be analyzed. In particular, information from subjects who underwent at least two nutritional visits with bioimpedance analysis with a gap of at least 3 months between them will be considered. The subjects will be characterized based on (i) the type of nutritional intervention (FMD only, LD only, or combinations of LD and FMD); (ii) the duration of the nutritional intervention (short, medium, or long); (iii) the degree of obesity (normal weight, overweight, and obese); and (iv) physio-pathological status.
Data Collection and Analysis Data will be collected retrospectively from the electronic medical records of the Valter Longo Foundation. Bioimpedance analysis, anthropometric measurements, and clinical parameters including lipid profiles will be used to assess changes in body composition, body fat percentage, lean mass percentage, phase angle, waist circumference, hip circumference, and blood lipid levels.
Statistical Analysis Statistical analyses will be performed using appropriate statistical software packages. Descriptive statistics will be used to summarize baseline characteristics, and paired t-tests or non-parametric equivalents will be used to compare pre- and post-intervention measurements. Analysis of variance will be used to compare outcomes across different subgroups based on type of intervention, duration, degree of obesity, and physio-pathological status. Correlation analyses may also be performed to explore associations between changes in body composition and other variables. A p-value of less than 0.05 will be considered statistically significant.
Ethical Considerations This study will be conducted in accordance with ethical principles and regulations governing clinical research. All data will be de-identified and handled in compliance with data protection regulations. Informed consent will be obtained from all subjects included in the study.
Conclusion This retrospective clinical study aims to investigate the effects of the longevity diet and the fasting-mimicking diet, either individually or in combination, on body composition, age-related disease risk factors, and aging markers. The study will provide valuable insights into the potential benefits of these dietary interventions in promoting health and longevity, which could have significant implications for public health and wellness.

Conditions: Overweight, Obesity, Metabolic Syndrome, Autoimmune Diseases, Inflammatory Disease, Health, Subjective
Being tested: Longevity diet alone or in combination with fasting mimicking diet
Keywords: Longevity, Fasting Mimicking Diet, Longevity Diet, Diet, Aging, FMD, Nutrition, Diseases, Clinical Trial, Fat Mass, Phase Angle, Muscle Mass, Caloric Restriction
Medical subject headings: Overweight, Obesity, Metabolic Syndrome, Autoimmune Diseases, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Longevity diet alone or in combination with fasting mimicking dietOther
The longevity diet generally consists of three isocaloric meals and one snack (for normal-weight individuals) or slightly hypocaloric meals (in the case of overweight or obesity). The diet consists of 50-60% of calories from complex carbohydrates, 30-35% of calories from mostly unsaturated fats, and 10-11% of calories from proteins, primarily from plant sources and fish, and occasionally from eggs, dairy, and meat, especially for those over 65. The diet is formulated to provide all necessary nutrients, including vitamins and minerals. The fasting-mimicking diet is a dietary intervention in which normal food is replaced with a standardized, highly hypocaloric vegan diet for a limited period of 5 consecutive days. This diet is designed to stimulate the same processes normally activated during fasting while minimizing the side effects of total food deprivation.

What is being measured

The primary outcome is the main question the study is designed to answer.

Fat mass in %
The percentage of the Fat Mass in measured through a Bioimpedance Analysis (BIA) or a caliper
Measured: Comparison of Fat mass in % at baseline and after a period between 3 months (minimum) and 2 years (maximum)

Secondary outcomes (5)

Phase Angle
The Phase Angle in measured through a Bioimpedance Analysis (BIA) in degrees
Measured: Comparison of Phase Angle at baseline and after a period between 3 months (minimum) and 2 years (maximum)
Free Fat Mass in percent
The percentage of the Free Fat Mass in measured through a Bioimpedance Analysis (BIA) or caliper
Measured: Comparison of Free Fat Mass in percent at baseline and after a period between 3 months (minimum) and 2 years (maximum)
Waist Circumference
The Waist circumference is measured through a anthropometric tape in cm
Measured: Comparison of Waist Circumference at baseline and after a period between 3 months (minimum) and 2 years (maximum)
Hips Circumference
The Hips circumference is measured through a anthropometric tape in cm
Measured: Comparison of Hips Circumference at baseline and after a period between 3 months (minimum) and 2 years (maximum)
Total Cholesterol
The Total Cholesterol is measured through blood samples analyzed in a private and sepatate laboratory (mg/dl)
Measured: Comparison of Total Cholesterol maximum 6 months before the first consultation and maximum 6 months after the last consultation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20191 Mar 2024

First posted15 Jul 2025
Study start1 Jan 2019
Primary completion1 Mar 2024
Study completion1 Mar 2024

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 OverweightStudies 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: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 365 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07065955
Sponsor's protocol ID: 2023-UCALPRG-0082112
Status last verified: Jul 2025
First submitted: 17 Mar 2025
Last updated: 15 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Ley SH, Ardisson Korat AV, Sun Q, Tobias DK, Zhang C, Qi L, Willett WC, Manson JE, Hu FB. Contribution of the Nurses' Health Studies to Uncovering Risk Factors for Type 2 Diabetes: Diet, Lifestyle, Biomarkers, and Genetics. Am J Public Health. 2016 Sep;106(9):1624-30. doi: 10.2105/AJPH.2016.303314. Epub 2016 Jul 26.
PubMed 27459454
Mahabir S, Willett WC, Friedenreich CM, Lai GY, Boushey CJ, Matthews CE, Sinha R, Colditz GA, Rothwell JA, Reedy J, Patel AV, Leitzmann MF, Fraser GE, Ross S, Hursting SD, Abnet CC, Kushi LH, Taylor PR, Prentice RL. Research Strategies for Nutritional and Physical Activity Epidemiology and Cancer Prevention. Cancer Epidemiol Biomarkers Prev. 2018 Mar;27(3):233-244. doi: 10.1158/1055-9965.EPI-17-0509. Epub 2017 Dec 18.
PubMed 29254934
Yu E, Rimm E, Qi L, Rexrode K, Albert CM, Sun Q, Willett WC, Hu FB, Manson JE. Diet, Lifestyle, Biomarkers, Genetic Factors, and Risk of Cardiovascular Disease in the Nurses' Health Studies. Am J Public Health. 2016 Sep;106(9):1616-23. doi: 10.2105/AJPH.2016.303316. Epub 2016 Jul 26.
PubMed 27459449
Li Y, Pan A, Wang DD, Liu X, Dhana K, Franco OH, Kaptoge S, Di Angelantonio E, Stampfer M, Willett WC, Hu FB. Impact of Healthy Lifestyle Factors on Life Expectancies in the US Population. Circulation. 2018 Jul 24;138(4):345-355. doi: 10.1161/CIRCULATIONAHA.117.032047.
PubMed 29712712
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.
PubMed 28202779
Crupi AN, Haase J, Brandhorst S, Longo VD. Periodic and Intermittent Fasting in Diabetes and Cardiovascular Disease. Curr Diab Rep. 2020 Dec 10;20(12):83. doi: 10.1007/s11892-020-01362-4.
PubMed 33301104
Fanti M, Mishra A, Longo VD, Brandhorst S. Time-Restricted Eating, Intermittent Fasting, and Fasting-Mimicking Diets in Weight Loss. Curr Obes Rep. 2021 Jun;10(2):70-80. doi: 10.1007/s13679-021-00424-2. Epub 2021 Jan 29.
PubMed 33512641
Gallus S, Odone A, Lugo A, Bosetti C, Colombo P, Zuccaro P, La Vecchia C. Overweight and obesity prevalence and determinants in Italy: an update to 2010. Eur J Nutr. 2013 Mar;52(2):677-85. doi: 10.1007/s00394-012-0372-y. Epub 2012 May 27.
PubMed 22645105
Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Fito M, Gea A, Hernan MA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts. N Engl J Med. 2018 Jun 21;378(25):e34. doi: 10.1056/NEJMoa1800389. Epub 2018 Jun 13.
PubMed 29897866
Mishra A, Mirzaei H, Guidi N, Vinciguerra M, Mouton A, Linardic M, Rappa F, Barone R, Navarrete G, Wei M, Brandhorst S, Di Biase S, Morgan TE, Ram Kumar S, Conti PS, Pellegrini M, Bernier M, de Cabo R, Longo VD. Fasting-mimicking diet prevents high-fat diet effect on cardiometabolic risk and lifespan. Nat Metab. 2021 Oct;3(10):1342-1356. doi: 10.1038/s42255-021-00469-6. Epub 2021 Oct 14.
PubMed 34650272
Brandhorst S, Choi IY, Wei M, Cheng CW, Sedrakyan S, Navarrete G, Dubeau L, Yap LP, Park R, Vinciguerra M, Di Biase S, Mirzaei H, Mirisola MG, Childress P, Ji L, Groshen S, Penna F, Odetti P, Perin L, Conti PS, Ikeno Y, Kennedy BK, Cohen P, Morgan TE, Dorff TB, Longo VD. A Periodic Diet that Mimics Fasting Promotes Multi-System Regeneration, Enhanced Cognitive Performance, and Healthspan. Cell Metab. 2015 Jul 7;22(1):86-99. doi: 10.1016/j.cmet.2015.05.012. Epub 2015 Jun 18.
PubMed 26094889

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of the Longevity Diet and the Fasting-mimicking Diet on Body Composition, Risk Factors for Age-related Diseases
ClinicalTrials.gov ID: NCT07065955
Acronym / sponsor ID: 2023-UCALPRG-0082112
Conditions: Overweight, Obesity, Metabolic Syndrome, Autoimmune Diseases, Inflammatory Disease, Health, Subjective
Keywords: Longevity, Fasting Mimicking Diet, Longevity Diet, Diet, Aging, FMD, Nutrition, Diseases
Study type: Observational
Recruitment status: Completed
Enrolment: 365 participants (actual)
Lead sponsor: Fondazione Valter LongoUniversity, hospital or other
Study start: 1 Jan 2019 (actual)
Primary completion: 1 Mar 2024 (actual)
Study completion: 1 Mar 2024 (actual)
First posted: 15 Jul 2025 (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.

In conclusion, this study provides valuable insights into the potential health and longevity benefits of the longevity diet and FMD, with implications for public wellness.

Detailed description

Introduction Aging is often accompanied by numerous chronic degenerative conditions that compromise the quality of life and lead to dependency. However, a favorable interaction between genetic and environmental factors could lead to a significantly higher life expectancy, free from conditions that significantly compromise both the quality and duration of life, highlighting that increased longevity is not necessarily accompanied by one or more pathological conditions. It is widely accepted that the quality and quantity of nutrition are essential factors in maintaining health and preventing diseases. Making healthy and conscious dietary choices can indeed alter the course of life in terms of both duration and health. Numerous epidemiological studies have demonstrated the critical role of a proper dietary regimen in the risk of developing age-related diseases. Furthermore, recent studies have highlighted how short periods of extreme calorie reduction with adequate nutrient intake (5 days, fasting-mimicking diet, FMD) can impact metabolism, producing numerous beneficial effects in both healthy individuals and those with chronic degenerative conditions such as cancer, cardiovascular diseases, diabetes, and autoimmune diseases. Theories about senescence usually focus on the aging process and not on the ability of organisms to stay young. The longevity diet proposed in this study is intended to be effective in achieving the goal of extending youth for as long as possible, optimizing protection, regeneration, and rejuvenation while minimizing diseases. It is based on five pillars that support the scientific evidence of the program: basic research, epidemiology, clinical studies, centenarian studies, and complex systems studies. Essentially, the longevity diet incorporates the dietary tradition of healthy centenarians, characterized by simplicity and products typical of their region of origin. This type of diet generally consists of three isocaloric meals and one snack (for normal-weight individuals) or slightly hypocaloric meals (in the case of overweight or obesity). The diet consists of 50-60% of calories from complex carbohydrates, 30-35% of calories from mostly unsaturated fats, and 10-11% of calories from proteins, primarily from plant sources and fish, and occasionally from eggs, dairy, and meat, especially for those over 65. The diet is formulated to provide all necessary nutrients, including vitamins and minerals. The fasting-mimicking diet is a dietary intervention in which normal food is replaced with a standardized, highly hypocaloric vegan diet for a limited period of 5 consecutive days. This diet is designed to stimulate the same processes normally activated during fasting while minimizing the side effects of total food deprivation. This retrospective clinical study aims to investigate the two different approaches: the longevity diet and the fasting-mimicking diet, to assess both their feasibility and effectiveness when used individually or in combination. 1.1 Background and Hypotheses The Italian population has moved away from the traditional Mediterranean diet and now predominantly follows a Western-style diet that is hypercaloric, rich in saturated fats, animal protein, and sugars. We hypothesize that a return to the original Mediterranean diet with modifications based on the scientific evidence of recent decades (longevity diet), and/or short periods of fasting-mimicking diet (5 days), can improve the overall health conditions of the population.
Objectives and Purpose of the Study Primary Objective: To evaluate whether the longevity diet and the fasting-mimicking diet, either individually or in combination, can reduce the percentage of body fat in a cohort of subjects stratified by gender, age, body mass index, and defined physio-pathological states. Secondary Objectives: To assess whether the longevity diet and the fasting-mimicking diet, either individually or in combination, can positively influence parameters related to the general health status of the analyzed sample, including (i) percentage of lean mass, (ii) phase angle as an indirect indicator of muscle function and cellular integrity, (iii) waist and hip circumference, (iv) total cholesterol, HDL, and LDL.
Study Design This is a retrospective, observational, single-center study to evaluate the effect of specific nutritional interventions (fasting-mimicking diet (FMD) and longevity diet (LD)) on reducing body fat. To achieve this, retrospective data from bioimpedance, anthropometric, and clinical analyses of subjects who underwent at least one of the two nutritional interventions (individually or in combination) at the Valter Longo Foundation in Milan from 2019 to 2024 will be analyzed. In particular, information from subjects who underwent at least two nutritional visits with bioimpedance analysis with a gap of at least 3 months between them will be considered. The subjects will be characterized based on (i) the type of nutritional intervention (FMD only, LD only, or combinations of LD and FMD); (ii) the duration of the nutritional intervention (short, medium, or long); (iii) the degree of obesity (normal weight, overweight, and obese); and (iv) physio-pathological status.
Data Collection and Analysis Data will be collected retrospectively from the electronic medical records of the Valter Longo Foundation. Bioimpedance analysis, anthropometric measurements, and clinical parameters including lipid profiles will be used to assess changes in body composition, body fat percentage, lean mass percentage, phase angle, waist circumference, hip circumference, and blood lipid levels.
Statistical Analysis Statistical analyses will be performed using appropriate statistical software packages. Descriptive statistics will be used to summarize baseline characteristics, and paired t-tests or non-parametric equivalents will be used to compare pre- and post-intervention measurements. Analysis of variance will be used to compare outcomes across different subgroups based on type of intervention, duration, degree of obesity, and physio-pathological status. Correlation analyses may also be performed to explore associations between changes in body composition and other variables. A p-value of less than 0.05 will be considered statistically significant.
Ethical Considerations This study will be conducted in accordance with ethical principles and regulations governing clinical research. All data will be de-identified and handled in compliance with data protection regulations. Informed consent will be obtained from all subjects included in the study.
Conclusion This retrospective clinical study aims to investigate the effects of the longevity diet and the fasting-mimicking diet, either individually or in combination, on body composition, age-related disease risk factors, and aging markers. The study will provide valuable insights into the potential benefits of these dietary interventions in promoting health and longevity, which could have significant implications for public health and wellness.

Study design

Observational model: Case only
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The bioimpedance, anthropometric, and clinical data of subjects who underwent at least one of the two nutritional interventions (individually or in combination) at the Valter Longo Foundation in Milan from 2019 to 2024 will be retrospectively analyzed. As this is a purely observational (retrospective) study with purely descriptive objectives, a formal power analysis estimation has not been conducted. However, considering that the Valter Longo Foundation in Milan is a regional reference point, it is estimated that approximately 250 subjects will be recruited retrospectively.

Key inclusion criteria (6 listed)

Healthy patients and/or those with diseases, excluding neoplastic and neurodegenerative pathologies;
Age >/= 18 years;
Body mass index >/= 18.5 kg/m2;
At least two visits, both characterized by bioimpedance and anthropometric analysis;
At least 3 months between the first and last bioimpedance and anthropometric analysis;

Key exclusion criteria (4 listed)

Age < 18 years;
Lack of informed consent or privacy;
Women who are pregnant or breastfeeding;
Patients affected by oncological and/or neurodegenerative pathologies.

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
Longevity diet alone or in combination with fasting mimicking dietThe longevity diet generally consists of three isocaloric meals and one snack (for normal-weight individuals) or slightly hypocaloric meals (in the case of overweight or obesity). The diet consists of 50-60% of calories from complex carbohydrates, 30-35% of calories from mostly unsaturated fats, and 10-11% of calories from proteins, primarily from plant sources and fish, and occasionally from eggs, dairy, and meat, especially for those over 65. The diet is formulated to provide all necessary nutrients, including vitamins and minerals. The fasting-mimicking diet is a dietary intervention in which normal food is replaced with a standardized, highly hypocaloric vegan diet for a limited period of 5 consecutive days. This diet is designed to stimulate the same processes normally activated during fasting while minimizing the side effects of total food deprivation.	Other	–

Primary outcome

Fat mass in %
Time frame: Comparison of Fat mass in % at baseline and after a period between 3 months (minimum) and 2 years (maximum)
The percentage of the Fat Mass in measured through a Bioimpedance Analysis (BIA) or a caliper

5 secondary outcomes

Phase Angle
Time frame: Comparison of Phase Angle at baseline and after a period between 3 months (minimum) and 2 years (maximum)
Free Fat Mass in percent
Time frame: Comparison of Free Fat Mass in percent at baseline and after a period between 3 months (minimum) and 2 years (maximum)
Waist Circumference
Time frame: Comparison of Waist Circumference at baseline and after a period between 3 months (minimum) and 2 years (maximum)
Hips Circumference
Time frame: Comparison of Hips Circumference at baseline and after a period between 3 months (minimum) and 2 years (maximum)
Total Cholesterol
Time frame: Comparison of Total Cholesterol maximum 6 months before the first consultation and maximum 6 months after the last consultation

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 15 Jul 2025.
Background: PubMed 27459454Ley SH, Ardisson Korat AV, Sun Q, Tobias DK, Zhang C, Qi L, Willett WC, Manson JE, Hu FB. Contribution of the Nurses' Health Studies to Uncovering Risk Factors for Type 2 Diabetes: Diet, Lifestyle, Biomarkers, and Genetics. Am J Public Health. 2016 Sep;106(9):1624-30. doi: 10.2105/AJPH.2016.303314. Epub 2016 Jul 26.
Background: PubMed 29254934Mahabir S, Willett WC, Friedenreich CM, Lai GY, Boushey CJ, Matthews CE, Sinha R, Colditz GA, Rothwell JA, Reedy J, Patel AV, Leitzmann MF, Fraser GE, Ross S, Hursting SD, Abnet CC, Kushi LH, Taylor PR, Prentice RL. Research Strategies for Nutritional and Physical Activity Epidemiology and Cancer Prevention. Cancer Epidemiol Biomarkers Prev. 2018 Mar;27(3):233-244. doi: 10.1158/1055-9965.EPI-17-0509. Epub 2017 Dec 18.
Background: PubMed 27459449Yu E, Rimm E, Qi L, Rexrode K, Albert CM, Sun Q, Willett WC, Hu FB, Manson JE. Diet, Lifestyle, Biomarkers, Genetic Factors, and Risk of Cardiovascular Disease in the Nurses' Health Studies. Am J Public Health. 2016 Sep;106(9):1616-23. doi: 10.2105/AJPH.2016.303316. Epub 2016 Jul 26.
Background: PubMed 29712712Li Y, Pan A, Wang DD, Liu X, Dhana K, Franco OH, Kaptoge S, Di Angelantonio E, Stampfer M, Willett WC, Hu FB. Impact of Healthy Lifestyle Factors on Life Expectancies in the US Population. Circulation. 2018 Jul 24;138(4):345-355. doi: 10.1161/CIRCULATIONAHA.117.032047.
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.
Background: PubMed 33301104Crupi AN, Haase J, Brandhorst S, Longo VD. Periodic and Intermittent Fasting in Diabetes and Cardiovascular Disease. Curr Diab Rep. 2020 Dec 10;20(12):83. doi: 10.1007/s11892-020-01362-4.
Background: PubMed 33512641Fanti M, Mishra A, Longo VD, Brandhorst S. Time-Restricted Eating, Intermittent Fasting, and Fasting-Mimicking Diets in Weight Loss. Curr Obes Rep. 2021 Jun;10(2):70-80. doi: 10.1007/s13679-021-00424-2. Epub 2021 Jan 29.
Background: PubMed 22645105Gallus S, Odone A, Lugo A, Bosetti C, Colombo P, Zuccaro P, La Vecchia C. Overweight and obesity prevalence and determinants in Italy: an update to 2010. Eur J Nutr. 2013 Mar;52(2):677-85. doi: 10.1007/s00394-012-0372-y. Epub 2012 May 27.
Background: PubMed 29897866Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Fito M, Gea A, Hernan MA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts. N Engl J Med. 2018 Jun 21;378(25):e34. doi: 10.1056/NEJMoa1800389. Epub 2018 Jun 13.
Background: PubMed 34650272Mishra A, Mirzaei H, Guidi N, Vinciguerra M, Mouton A, Linardic M, Rappa F, Barone R, Navarrete G, Wei M, Brandhorst S, Di Biase S, Morgan TE, Ram Kumar S, Conti PS, Pellegrini M, Bernier M, de Cabo R, Longo VD. Fasting-mimicking diet prevents high-fat diet effect on cardiometabolic risk and lifespan. Nat Metab. 2021 Oct;3(10):1342-1356. doi: 10.1038/s42255-021-00469-6. Epub 2021 Oct 14.
Background: PubMed 26094889Brandhorst S, Choi IY, Wei M, Cheng CW, Sedrakyan S, Navarrete G, Dubeau L, Yap LP, Park R, Vinciguerra M, Di Biase S, Mirzaei H, Mirisola MG, Childress P, Ji L, Groshen S, Penna F, Odetti P, Perin L, Conti PS, Ikeno Y, Kennedy BK, Cohen P, Morgan TE, Dorff TB, Longo VD. A Periodic Diet that Mimics Fasting Promotes Multi-System Regeneration, Enhanced Cognitive Performance, and Healthspan. Cell Metab. 2015 Jul 7;22(1):86-99. doi: 10.1016/j.cmet.2015.05.012. Epub 2015 Jun 18.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Overweight and Obesity, run by Fondazione Valter Longo 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 6 inclusion and 4 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 15 Jul 2025. 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?

Fat mass in % (time frame: Comparison of Fat mass in % at baseline and after a period between 3 months (minimum) and 2 years (maximum)). 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 NCT07065955, 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 15 Jul 2025.