Actively Recruiting
Follow up Study of Varapodio Trial: Effect of Longevity and Fasting Mimicking Diet on Risk Factors Age Correlated and Biomarkers of Aging
Led by Fondazione Valter Longo · Updated on 2025-12-01
135
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
Sponsors
F
Fondazione Valter Longo
Lead Sponsor
U
Universita degli Studi di Palermo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Follow up Study of Varapodio Trial: Effect of Longevity and Fasting Mimicking Diet on Risk Factors Age Correlated and Biomarkers of Aging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 30 to 65 years
- Participants who completed a previous FMD-based clinical trial less than 6 months ago
- Willingness to continue the FMD program for an additional 12 months
- Ability to comply with study visits and procedures
You will not qualify if you...
- Having a family member already enrolled in the study
- Allergy to tree nuts (macadamia, cashew, almond, pecan), soy, oats, sesame, or celery/celeriac
- Pregnancy or breastfeeding
- Cancer diagnosis within the past 5 years
- Myocardial infarction or stroke within the past 5 years
- Chronic steroid use longer than 45 consecutive days
- Insulin-dependent diabetes or use of insulin or insulin-like drugs
- Use of hypoglycemic agents other than metformin
- Severe hypertension (systolic > 200 mmHg or diastolic > 105 mmHg)
- Recent changes in medications, use of narcotics, corticosteroids, anticoagulants (except aspirin), or neuroactive medications within specified timeframes
- Known allergies or intolerance to study products
- Clinically significant vital sign abnormalities
- Serious unstable illnesses including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, immunologic, or hematologic diseases
- Known infection with HIV, TB, or Hepatitis B or C
- History or current diagnosis of cardiovascular disease, autoimmune diseases, significant liver/kidney disease, malignancy (except treated >2 years ago), or serious mental illness
- Use of drugs of abuse within 15 days prior to study start
- Regular intake of excess alcohol (>14 drinks/week for females, >21 drinks/week for males)
- Conditions preventing bioelectrical impedance testing (e.g., prostheses, pacemakers)
- Inability to comply with study or follow-up visits
- Abnormal laboratory findings outside specified ranges
- Women of childbearing potential must use contraception and have negative pregnancy test prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ambulatorio Medico presso Biblioteca Comunale
Varapodio, Calabria, Italy, Italy, 89010
Actively Recruiting
Research Team
R
Romina Inés Cervigni
CONTACT
A
Alberto Montesanto
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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