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.
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Single group
fasting mimicking diet
BehavioralThe 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.
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.
maintenance of at least 50% of one or more risk factors improvements achieved during the previous clinical trial
maintenance of at least 50% of one or more risk factors improvements achieved during the previous clinical trial and measured after one year of follow up FMD cycles every 3 months including improvements in: body mass, body mass index, blood pressure, IGF-1, haemoglobin A1c, fasting glucose, LDL, total cholesterol, and C-Reactive Protein. Determine long-term trends in the reduction/stabilization in the use of antihypertensive and glucose-lowering drugs or other commonly used medications.
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Fondazione Valter Longo
Lead sponsor
Universita degli Studi di Palermo
Collaborator
University of Calabria
Collaborator
Regione Calabria / Comune Varapodio
Collaborator
European Longevity Institute
Collaborator
