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

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)

Interventions

BEHAVIORAL

fasting mimicking diet

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.

Sponsors & Collaborators

• Universita degli Studi di Palermo

  collaborator OTHER

• University of Calabria

  collaborator OTHER

• Regione Calabria / Comune Varapodio

  collaborator UNKNOWN

• European Longevity Institute

  collaborator UNKNOWN

• Fondazione Valter Longo

  lead OTHER

Principal Investigators

• Romina Inés Cervigni · Fondazione Valter Longo

• Alberto Montesanto · University of Calabria

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-05-02

Primary Completion

2027-05-02

Completion

2027-06-02

Countries

• Italy

Study Locations