What is the mechanism of action of this treatment?

Dietary treatments, such as the Fasting Mimicking Diet (FMD), primarily work by inducing autophagy, a cellular process that removes damaged components and promotes cellular repair. This is achieved through caloric restriction, which reduces nutrient signaling pathways like mTOR, thereby enhancing autophagy. For patients, this is significant because autophagy can improve cellular health, potentially reducing the risk of chronic diseases, enhancing immune function, and improving overall metabolic health. These benefits make dietary interventions a promising approach for improving long-term health outcomes.

What side effects are associated with this type of intervention?

Common treatments that induce autophagy through dietary restriction, such as fasting mimicking diets (FMD) and caloric restriction mimetics (CRM), can have several side effects. These may include transient reductions in general protein acetylation, gastrointestinal discomfort, and potential nutrient deficiencies if not properly managed. Additionally, rapid weight loss and fasting can exacerbate certain conditions, leading to complications such as hypoglycemia, especially in individuals with underlying health issues like diabetes.

What prior FDA approvals exist?

The FDA has approved several treatments for metabolic conditions and weight management that involve dietary interventions. For instance, drugs like semaglutide and liraglutide, which are GLP-1 receptor agonists, have been approved for weight loss and type 2 diabetes management. These medications can mimic some effects of dietary restriction by promoting satiety and reducing caloric intake. While specific FDA approvals for diets that induce autophagy, such as the Fasting Mimicking Diet, are not detailed, these pharmacological treatments share a common goal of metabolic improvement through dietary modulation.

What other types of research exist?

Promising alternatives to the Fasting Mimicking Diet for inducing autophagy through dietary restriction include: 1) Caloric Restriction (CR), which has been shown to delay disease onset and improve metabolic health; 2) Intermittent Fasting (IF), which involves cycles of eating and fasting and has been associated with improved metabolic markers and autophagy; 3) Time-Restricted Feeding (TRF), where eating is limited to a specific window of time each day, promoting metabolic health and autophagy; and 4) Ketogenic Diet (KD), a high-fat, low-carbohydrate diet that can induce a state of ketosis, promoting autophagy and metabolic benefits.

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Fasting Mimicking Diet for Health Improvement

N/A

Waitlist Available

Led By Sara Espinoza, MD

Research Sponsored by L-Nutra Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 8

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how a special diet that mimics fasting affects cell-cleaning processes in healthy people. The diet helps with weight loss and reduces insulin levels while activating a natural cell-cleaning process. The fasting-mimicking diet (FMD) is designed to mimic the effects of fasting by being low in calories, sugars, and proteins, but high in unsaturated fats.

Who is the study for?

This trial is for generally healthy volunteers with a BMI between 20-35 who can consent to study procedures. It's not suitable for those on diabetes treatment (except metformin), with alcohol dependency, type 1 diabetes, pregnant women, immune suppression drug users, or anyone with conditions that the investigator feels are risky.

What is being tested?

The study tests how a Fasting Mimicking Diet (FMD) affects autophagy in white blood cells over five days. Autophagy is the body's way of cleaning out damaged cells to regenerate newer, healthier cells.

What are the potential side effects?

Potential side effects aren't detailed but may include hunger, fatigue, dizziness or irritability due to calorie restriction. Specific reactions could vary based on individual health and adherence to the diet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Autophagy flux

Secondary study objectives

Autophagy-related gene expression

Metabolomic change

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: FMD2-ProMeteExperimental Treatment1 Intervention

Subjects in FMD2 groups will be provided and asked to consume a 5-day low calorie fasting-mimicking diet (ProMeteTM).

Group II: FMD1-ProLonExperimental Treatment1 Intervention

Subjects in FMD1 groups will be provided and asked to consume a 5-day low calorie fasting-mimicking diet (ProLonTM).

Group III: ControlActive Control1 Intervention

Subjects in the control group will be asked to keep their normal diet during the study period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fasting Mimicking Diet

2021

N/A

~60

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Dietary treatments, such as the Fasting Mimicking Diet (FMD), primarily work by inducing autophagy, a cellular process that removes damaged components and promotes cellular repair. This is achieved through caloric restriction, which reduces nutrient signaling pathways like mTOR, thereby enhancing autophagy. For patients, this is significant because autophagy can improve cellular health, potentially reducing the risk of chronic diseases, enhancing immune function, and improving overall metabolic health. These benefits make dietary interventions a promising approach for improving long-term health outcomes.

Effects of Vestibular Damage on the Sleep and Expression Level of Orexin in the Hypothalamus of Rats and Its Correlation with Autophagy and Akt Tumor Signal Pathway.Amino Acid Starvation Sensitizes Resistant Breast Cancer to Doxorubicin-Induced Cell Death.Caloric restriction promotes the stemness and antitumor activity of T lymphocytes.