What is this study trying to find out about body composition and aging?

This study aims to understand the long-term effects of the fasting mimicking diet and the Longevity Diet on body fat and age-related health markers. Researchers want to see how these diets affect fat mass, cardiovascular risk factors, and biomarkers linked to aging. The study is sponsored by Fondazione Valter Longo and involves adults aged 30 to 65.

Who may be eligible for this body composition clinical trial?

Adults aged 30 to 65 years who have previously participated in related fasting mimicking diet studies may be eligible. Participants should not be pregnant or breastfeeding and must not have recent serious illnesses like cancer or heart attack. Please review eligibility criteria for more details.

Is there any cost to participate in this body composition clinical trial?

Study-related care, including the study diet and all trial visits, is provided at no cost. Personal travel or other expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

All Genders

Healthy Volunteers

ID07255300

Follow-up Study on the Effects of the Fasting Mimicking Diet and Longevity Diet on Body Composition and Age-Related Risk Factors in Adults

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

135

Participants Needed

Research Sites

4 weeks

Total Duration

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

You may qualify if you...

Subjects aged 30 to 65 years

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

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