Follow up Study of Varapodio Trial: Effect of Longevity and Fasting Mimicking Diet on Risk Factors Age Correlated and Biomarkers of Aging

NCT07255300 | Recruiting

• 1 other identifier: 10
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

A large ongoing randomized, open-label trial aimed at evaluating the effects of two different dietary interventions, FMD and LD, on body composition and cardiovascular (CV) biomarkers in a real word population (NCT05698654) is actually ongoing. This trial started in January 2024 will enrol 501 adult subjects between the ages of 30 and 65: 167 subjects randomized to the FMD arm with a 5-day meal program once every three months for a 6-month period (arm 1); 167 subjects randomized to follow the FMD plus a Longevity Diet program (FMD+LD) for a 6-month period (arm 2); 167 randomized to the control group (arm 3) that will continue their usual diet. On 2024,410, participants were enrolled and randomly assigned to FMD, FMD + LD, or control arm. Although preliminary data demonstrated the beneficial effects of such nutritional plans on body weight, BMI, body composition, and cardiovascular (CV) biomarkers, limited data is available on the long-term effects of these powerful nutritional interventions.

Conditions

Fat Mass; Risk Factors Cardiovascular Disease; Epigenetic Aging; Metabolism Changes; Overweight (BMI > 25); Risk Behavior; Obesity (Disorder)

Keywords

fasting; fasting mimicking diet; Longevity Diet; Longevity; Diet; Aging; FMD; Nutrition; Diseases; LD; Clinical Trial; Randomized; Health; Fat Mass

Outcome Measures

Primary Outcomes (1)

• Body Fat Percentage

  Maintenance of at least 50% of the fat mass lost during the previous trial and measured after one follow up year on FMD every 3 months.

  Time Frame: Comparison of the clinical marker up to 7 days after the randomization and 1 year after the randomization.

Secondary Outcomes (1)

• maintenance of at least 50% of one or more risk factors improvements achieved during the previous clinical trial

  comparison from day 1 after randomization and one year after the randomization

Study Arms (1)

Fasting Mimicking Diet

EXPERIMENTAL

The fasting-mimicking diet (FMD) group, will be instructed on the benefits and use of the fasting-mimicking diet and how it should be used. This group will have to perform the fasting-mimicking diet once every 4 months (3 cycles in 1 year).

Behavioral: fasting mimicking diet

Interventions

fasting mimicking diet BEHAVIORAL

The subjects will be instructed to follow their usual diet plan, except for 5 days when they eat the foods in the FMD box.The fasting-mimicking diet consists of a blend of 100% plant based nutrients generally regarded as safe. The formulation of these products is based on studies carried out at the Longevity Institute of the University of Southern California and his collaborators over several decades of studies. This food plan provides for the replacement of the normal diet with the organic plant products contained in the fasting-mimicking diet for five consecutive days.

Fasting Mimicking Diet

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of 30-65 years of age;

You may not qualify if:

• individuals with a family member already included in the study; individuals who are allergic to tree nuts (macadamia, cashew, almond, pecan), soy, oats, sesame, or celery/celeriac; pregnant females; Individuals with any documented cancer diagnosis within the past 5 years; documented myocardial infarction within past 5 years; documented cerebrovascular accident within past 5 years; chronic steroid use (longer than 45 consecutive days); insulin-dependent diabetes mellitus; individuals taking insulin or insulin-like drugs and individuals taking hypoglycemic agents other than metformin. In this last case, close attention will therefore be paid to the self-monitoring of blood glucose during the FMD cycles; Individuals with severe hypertension (systolic greater than 200 mmHg and or diastolic greater than 105 mmHg.
• Change in prescription medications, over-the-counter (OTC) medications, medical foods, and nutritional supplements within 30 days prior to the start and for the duration of the study.
• Use of medications classified as narcotics 15 days prior start and for the duration of the study.
• Use of prescription medications and/or over-the-counter medications for acute and semi- acute medical conditions 15 days prior to start and for the duration of the study.
• Use of acetaminophen is permitted on an as-needed basis. Use of an investigational drug or participation in an investigational study within 30 days prior to the start and for the duration of the study.
• Use of oral or injectable corticosteroids within 30 days prior to the start and for the duration of the study.
• Use of anticoagulant medications (heparin compounds or warfarin) within 30 days prior to the start and for the duration of the study. Use of aspirin 81 mg or 325 mg once daily is permitted.
• Use of neuroactive prescription medications including major and atypical antipsychotic medications, anti-depressants, anti-anxiolytics, and epilepsy medications within 30 days prior to the start and for the duration of the study.
• (subjects will not be allowed to discontinue prohibited prescription medications to meet enrolment criteria).
• A history of allergy or intolerance to study products. Detailed descriptions of study product are included in Section 4.1 and 4.2, appended to the Study Informed Consent.
• Clinically significant vital sign abnormalities (systolic blood pressure \<90 mmHg or \>200 mmHg, diastolic blood pressure \<50 mmHg or \>105 mmHg or resting heart rate of \<50 or \>100 bpm) at screening visit.
• A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, immunologic, or hematologic disease.
• Known infection with HIV, TB or Hepatitis B or C.
• A current diagnosis or personal history of:
• Any cardiovascular disease including myocardial infarction, angina, cardiovascular surgery (within 5 years), congestive heart failure, cardiac arrhythmias or conduction abnormalities, cerebrovascular accident, transient ischemic attack (TIA), or peripheral vascular disease, deep vein thrombosis or pulmonary embolus. Diabetes mellitus requiring inhaled or injected insulin.

Sponsors & Collaborators

• Fondazione Valter Longo: lead
• Universita degli Studi di Palermo: collaborator
• University of Calabria: collaborator
• Regione Calabria / Comune Varapodio: collaborator
• European Longevity Institute: collaborator

Study Sites (1)

Ambulatorio Medico presso Biblioteca Comunale

Varapodio, Calabria, Italy, 89010, Italy

RECRUITING

Related Publications (7)

• Pollack MN. Insulin, insulin-like growth factors, insulin resistance, and neoplasia. Am J Clin Nutr. 2007 Sep;86(3):s820-2. doi: 10.1093/ajcn/86.3.820S.

  PMID: 18265475 RESULT

• Levine ME, Suarez JA, Brandhorst S, Balasubramanian P, Cheng CW, Madia F, Fontana L, Mirisola MG, Guevara-Aguirre J, Wan J, Passarino G, Kennedy BK, Wei M, Cohen P, Crimmins EM, Longo VD. Low protein intake is associated with a major reduction in IGF-1, cancer, and overall mortality in the 65 and younger but not older population. Cell Metab. 2014 Mar 4;19(3):407-17. doi: 10.1016/j.cmet.2014.02.006.

  PMID: 24606898 RESULT

• 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 RESULT

• 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 RESULT

• Houston M, Hays L. Acute effects of an oral nitric oxide supplement on blood pressure, endothelial function, and vascular compliance in hypertensive patients. J Clin Hypertens (Greenwich). 2014 Jul;16(7):524-9. doi: 10.1111/jch.12352. Epub 2014 Jun 24.

  PMID: 24962851 RESULT

• 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 RESULT

• Knoops KT, de Groot LC, Kromhout D, Perrin AE, Moreiras-Varela O, Menotti A, van Staveren WA. Mediterranean diet, lifestyle factors, and 10-year mortality in elderly European men and women: the HALE project. JAMA. 2004 Sep 22;292(12):1433-9. doi: 10.1001/jama.292.12.1433.

  PMID: 15383513 RESULT

MeSH Terms

Conditions

Overweight; Risk-Taking; Obesity; Fasting; Disease

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Feeding Behavior; Pathologic Processes

Study Officials

• Romina Inés Cervigni

  Fondazione Valter Longo

  STUDY DIRECTOR

• Alberto Montesanto

  University of Calabria

  STUDY CHAIR

Central Study Contacts

Romina Inés Cervigni

CONTACT

+390225138307; rcervigni@fondazionevalterlongo.org

Alberto Montesanto

CONTACT

+3930984492901; alberto.montesanto@unical.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: December 1, 2025
• Study Start: May 2, 2025
• Primary Completion (Estimated): May 2, 2027
• Study Completion (Estimated): June 2, 2027
• Last Updated: December 1, 2025

Record last verified: 2025-08

Locations

IT (1)