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Fasting diet Follow-Up: can you keep the weight off and age better?

NCT ID NCT07255300

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows adults aged 30-65 who previously tried a fasting-mimicking diet (FMD) to see if they can maintain fat loss and heart health improvements for one more year. Participants will continue FMD cycles every three months. The goal is to check if these benefits last and if the diet affects aging markers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fasting-mimicking diet (plant-based meal program)
What this could lead to
If successful, this could show that periodic fasting-mimicking diets help people keep off lost fat and maintain heart health improvements long-term.
What could go wrong
This is a follow-up study with no new treatment, and results depend on people sticking to the diet. It may not show lasting benefits or apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 135 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Subjects of 30-65 years of age; Exclusion Criteria: individuals with a family member already included in the study; individuals who are allergic to tree nuts (macadamia, cashew, almond, pecan), soy, oats, sesame, or celery/celeriac; pregnant females; Individuals with any documented cancer diagnosis within the past 5 years; documented myocardial infarction within past 5 years; documented cerebrovascular accident within past 5 years; chronic steroid use (longer than 45 consecutive days); insulin-dependent diabetes mellitus; individuals taking insulin or insulin-like drugs and individuals taking hypoglycemic agents other than metformin. In this last case, close attention will therefore be paid to the self-monitoring of blood glucose during the FMD cycles; Individuals with severe hypertension (systolic greater than 200 mmHg and or diastolic greater than 105 mmHg. Change in prescription medications, over-the-counter (OTC) medications, medical foods, and nutritional supplements within 30 days prior to the start and for the duration of the study. Use of medications classified as narcotics 15 days prior start and for the duration of the study. Use of prescription medications and/or over-the-counter medications for acute and semi- acute medical conditions 15 days prior to start and for the duration of the study. Use of acetaminophen is permitted on an as-needed basis. Use of an investigational drug or participation in an investigational study within 30 days prior to the start and for the duration of the study. Use of oral or injectable corticosteroids within 30 days prior to the start and for the duration of the study. Use of anticoagulant medications (heparin compounds or warfarin) within 30 days prior to the start and for the duration of the study. Use of aspirin 81 mg or 325 mg once daily is permitted. Use of neuroactive prescription medications including major and atypical antipsychotic medications, anti-depressants, anti-anxiolytics, and epilepsy medications within 30 days prior to the start and for the duration of the study. (subjects will not be allowed to discontinue prohibited prescription medications to meet enrolment criteria). A history of allergy or intolerance to study products. Detailed descriptions of study product are included in Section 4.1 and 4.2, appended to the Study Informed Consent. Clinically significant vital sign abnormalities (systolic blood pressure \<90 mmHg or \>200 mmHg, diastolic blood pressure \<50 mmHg or \>105 mmHg or resting heart rate of \<50 or \>100 bpm) at screening visit. A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, immunologic, or hematologic disease. Known infection with HIV, TB or Hepatitis B or C. A current diagnosis or personal history of: Any cardiovascular disease including myocardial infarction, angina, cardiovascular surgery (within 5 years), congestive heart failure, cardiac arrhythmias or conduction abnormalities, cerebrovascular accident, transient ischemic attack (TIA), or peripheral vascular disease, deep vein thrombosis or pulmonary embolus. Diabetes mellitus requiring inhaled or injected insulin. Any autoimmune disease such as inflammatory bowel disease (including Crohn's disease and/or ulcerative colitis), multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, polymyositis, scleroderma and/or thyroiditis. Any significant liver or kidney disease such as cirrhosis or non-alcoholic fatty liver disease, glomerulonephritis, and/or ongoing dialysis treatment. Any malignancy (with the exception of adequately treated malignancies with no known recurrence for \>2 years). Any serious mental illness including a history of attempted suicide. Any medical condition that in the opinion of the primary care doctor or a specialist would preclude safe participation in this study or interfere with compliance. Use of drugs of abuse (such as marijuana, cocaine, phencyclidine \[PCP\] and methamphetamine) 15 days prior to Day 1 and for the duration of the study. History of regular intake of \>14 alcoholic drinks per week for females, and \>21 drinks per week for males (1 drink = 35 cl. beer, 12 cl. wine, or 30 ml. hard liquor). Technical reasons Any condition in which bioelectrical impedance testing would be impossible or uninterpretable (e.g. prostheses in extremities on both sides, limb amputation, implanted pacemaker, inability to lay still or supine, or skin defects on preferred electrode placement sites. Other Exclusion Criteria: Inability to comply with study and/or follow-up visits. Any concurrent condition (including clinically significant abnormalities in medical history, physical examination or laboratory evaluations) which, in the opinion of the PI, would preclude safe participation in this study or interfere with compliance. Any sound medical, psychiatric and/or social reason which, in the opinion of the PI, would preclude safe participation in this study or interfere with compliance. Abnormal laboratory findings including: abnormal blood counts (hematocrit \< 33% or \> 47%; WBC \< 3.0 or \> 12.0 x10\^3/mm3; platelets \< 140 or \> 500 x 10\^9/L); abnormal kidney function test (creatinine \> 2.5 mg/dL) or liver function test(s) (AST, ALT, alkaline phosphatase) \> 1.5X the upper limit of normal; serum calcium \> 11 mg/dL); serum K \< 3.5 mEq/L; Na \< 134 or \> 148 mmolL-1 Women of Childbearing Potential Contraception: the effects of the study products on the developing human fetus have not been studied extensively. For this reason, women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Females of childbearing potential will have a pregnancy test prior to receiving study products. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform study staff and her primary care physician immediately. Pregnancy: because there is an unknown but potential risk for adverse events in pregnant women during treatment with the study products, pregnant women are not eligible for study participation. Breast-feeding: Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study products, breastfeeding mothers are not eligible for study participation.

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Conditions

The condition(s) this trial relates to.

disease Fasting metabolic disease Obesity obesity disorder Overweight Risk-Taking

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ambulatorio Medico presso Biblioteca Comunale

    RECRUITING

    Varapodio, Calabria, Italy, 89010, Italy

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