Longevity Diet and the Fasting-mimicking Diet

NCT07065955 | Completed

• 1 other identifier: 2023-UCALPRG-0082112
• Study Type: observational
• Target: 365
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight; Obesity; Metabolic Syndrome; Autoimmune Diseases; Inflammatory Disease; Health, Subjective

Keywords

Longevity; Fasting Mimicking Diet; Longevity Diet; Diet; Aging; FMD; Nutrition; Diseases; Clinical Trial; Fat Mass; Phase Angle; Muscle Mass; Caloric Restriction

Outcome Measures

Primary Outcomes (1)

• Fat mass in %

  The percentage of the Fat Mass in measured through a Bioimpedance Analysis (BIA) or a caliper

  Comparison of Fat mass in % at baseline and after a period between 3 months (minimum) and 2 years (maximum)

Secondary Outcomes (5)

• Phase Angle

  Comparison of Phase Angle at baseline and after a period between 3 months (minimum) and 2 years (maximum)

• Free Fat Mass in percent

  Comparison of Free Fat Mass in percent at baseline and after a period between 3 months (minimum) and 2 years (maximum)

• Waist Circumference

  Comparison of Waist Circumference at baseline and after a period between 3 months (minimum) and 2 years (maximum)

• Hips Circumference

  Comparison of Hips Circumference at baseline and after a period between 3 months (minimum) and 2 years (maximum)

• Total Cholesterol

  Comparison of Total Cholesterol maximum 6 months before the first consultation and maximum 6 months after the last consultation

Interventions

Longevity diet alone or in combination with fasting mimicking diet OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Valter Longo: lead

Study Sites (1)

Fondazione Valter Longo Onlus

Milan, 20122, Italy

Location

Related Publications (11)

• 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.

  PMID: 27459454 BACKGROUND

• 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.

  PMID: 29254934 BACKGROUND

• 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.

  PMID: 27459449 BACKGROUND

• 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.

  PMID: 29712712 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

• 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.

  PMID: 33301104 BACKGROUND

• 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.

  PMID: 33512641 BACKGROUND

• 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.

  PMID: 22645105 BACKGROUND

• 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.

  PMID: 29897866 BACKGROUND

• 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.

  PMID: 34650272 BACKGROUND

• 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.

  PMID: 26094889 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity; Metabolic Syndrome; Autoimmune Diseases; Disease

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: July 15, 2025
• Study Start: January 1, 2019
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

IT (1)