Actively Recruiting

Phase Not Applicable
All Genders
Healthy Volunteers
ID07255300

Follow up Study of the Effects of the Longevity and the Fasting Mimicking Diet on Body Composition, Age-related Risk Factors and Biomarkers of Aging in a Randomized Study 1 and 2

Led by Fondazione Valter Longo · Updated on 2025-12-01

135

Participants Needed

1

Research Sites

4 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

Researchers are studying the long-term effects of two dietary interventions, the fasting mimicking diet (FMD) and the Longevity Diet (LD), on body composition and cardiovascular biomarkers in adults aged 30 to 65. This large randomized, open-label trial builds on earlier studies showing short-term benefits of these diets on body weight, BMI, and cardiovascular health, aiming to understand their impact over a longer period. Participants are divided into groups, including one following the FMD with a 5-day meal program every three months for one year, and another group that previously completed FMD cycles continuing the FMD plan for an additional year. The FMD involves consuming a plant-based nutrient meal replacement for five consecutive days. Participants receive the FMD boxes and ketone test strips to self-monitor during the diet cycles. Throughout the study, participants undergo body composition assessments using bioelectrical impedance analysis, measurements of height, weight, vital signs, and laboratory blood tests at baseline and follow-up visits after three and five FMD cycles. Researchers monitor adherence, safety, and changes in fat mass, cardiovascular risk factors, and medication use. The study aims to evaluate the maintenance of fat mass loss and risk factor improvements over one year of follow-up.

CONDITIONS

Brief 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

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects aged 30 to 65 years
Not Eligible

You will not qualify if you...

  • Individuals with a family member already included in the study
  • Allergy to tree nuts (macadamia, cashew, almond, pecan), soy, oats, sesame, or celery/celeriac
  • Pregnant females
  • Individuals with any cancer diagnosis within past 5 years
  • History of myocardial infarction within past 5 years
  • History of cerebrovascular accident within past 5 years
  • Chronic steroid use longer than 45 consecutive days
  • Insulin-dependent diabetes mellitus
  • Use of insulin or insulin-like drugs or hypoglycemic agents other than metformin
  • Severe hypertension (systolic >200 mmHg or diastolic >105 mmHg)
  • Recent change in prescription or OTC medications within 30 days before study start
  • Use of narcotics within 15 days before study start
  • Use of medications for acute or semi-acute conditions within 15 days before study start
  • Use of investigational drugs within 30 days before study start
  • Use of oral or injectable corticosteroids within 30 days before study start
  • Use of anticoagulant medications (except low-dose aspirin) within 30 days before study start
  • Use of neuroactive prescription medications within 30 days before study start
  • History of allergy or intolerance to study products
  • Clinically significant vital sign abnormalities at screening
  • 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
  • Current or personal history of cardiovascular diseases or diabetes needing insulin
  • Autoimmune diseases like inflammatory bowel disease, multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, polymyositis, scleroderma, or thyroiditis
  • Significant liver or kidney diseases
  • Malignancy except adequately treated with no recurrence for over 2 years
  • Serious mental illness including history of attempted suicide
  • Use of drugs of abuse within 15 days before study start
  • History of heavy alcohol intake (more than 14 drinks/week for females or 21 drinks/week for males)
  • Conditions preventing bioelectrical impedance testing
  • Inability to comply with study or follow-up visits
  • Any condition that would preclude safe participation or interfere with compliance
  • Abnormal laboratory findings including blood counts, kidney or liver function, electrolytes
  • Women of childbearing potential must use contraception and have negative pregnancy test
  • Pregnant or breastfeeding women are excluded

AI-Screening

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Your Study Journey

Screening

Duration - Up to 3 years recruitment period

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - 1 year

Participants follow a 5-day fasting mimicking diet meal program every four months for one year to assess its long-term effects on body composition and biomarkers of aging.

1 baseline visit and 2 follow-up visits at 6 and 12 months

Trial Site Locations

Total: 1 location

1

Ambulatorio Medico presso Biblioteca Comunale

Varapodio, Calabria, Italy, Italy, 89010

Actively Recruiting

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Research Team

R

Romina Inés Cervigni

A

Alberto Montesanto

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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Published Research Related To This Trial

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.

Morgan E Levine, Jorge A Suarez, Sebastian Brandhorst...

https://pubmed.ncbi.nlm.nih.gov/24606898

Acute effects of an oral nitric oxide supplement on blood pressure, endothelial function, and vascular compliance in hypertensive patients.

Mark Houston, Laurie Hays

https://pubmed.ncbi.nlm.nih.gov/24962851

A Periodic Diet that Mimics Fasting Promotes Multi-System Regeneration, Enhanced Cognitive Performance, and Healthspan.

Sebastian Brandhorst, In Young Choi, Min Wei...

https://pubmed.ncbi.nlm.nih.gov/26094889

Mediterranean diet, lifestyle factors, and 10-year mortality in elderly European men and women: the HALE project.

Kim T B Knoops, Lisette C P G M de Groot, Daan Kromhout...

https://pubmed.ncbi.nlm.nih.gov/15383513