Fasting Mimicking Diet and Autophagy

L-Nutra

Status: Active, not recruiting

Conditions: Autophagy; Diet

Treatments: Combination Product: Fasting Mimicking Diet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06115551

LNT22-017

Details and patient eligibility

About

This study aims to evaluates autophagy in circulating white blood cells from generally healthy human volunteers exposed to fasting mimicking diet (FMD), a 5-day dietary regimen.

Full description

Fasting-mimicking diet (FMD) was developed to mimic the endocrine and metabolic effects that water-only fasting, while providing a modest calories and essential nutrients. The health benefits of FMD are caused by several molecular mechanisms, including the reduction of body weight, ectopic fat storage, insulin levels, endogenous glucose production and IGF-1. Autophagy is a catabolic membrane-trafficking phenomenon observed in yeast and mammalian cells. Nutrient deprivation induces autophagy. Autophagy has been proposed to be a fundamental cellular process being linked to aging and the progression of age-related diseases. The objective of this study is to evaluate the effects of consuming two FMD formulations on the autophagy process in the cell.

Enrollment: 30 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ability and willingness to provide written informed consent;
• Ability and willingness to perform the study tests and adhere to study protocol (to the best of the participant's knowledge);
• BMI 20-35 kg/m2 (inclusive) at screening;

Exclusion criteria

• Diabetes treatment other than diet or metformin monotherapy;
• History of gastric bypass;
• Subjects with recent weight loss (>5%), use of weight loss medication, participated in a weight loss program in the past 3 months;
• Type 1 diabetes (based on medical history provided at screening);
• Use of immune suppression drugs;
• Contraindication for study foods (special food needs and allergy);
• Women who are pregnant;
• Alcohol dependency (alcohol intake greater than two drinks per day for women and three drinks per day for men).
• Has any medical disease or condition that, in the opinion of the principal investigator (PI) or appropriate study personnel, precludes study participation* (*Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial);

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Control

No Intervention group

Description:

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

FMD1-ProLon

Experimental group

Description:

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

Treatment:

Combination Product: Fasting Mimicking Diet

FMD2-ProMete

Experimental group

Description:

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

Treatment:

Combination Product: Fasting Mimicking Diet