Fasting Mimicking Diet and Autophagy

NCT ID: NCT06115551

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-02
• Study Completion Date: 2024-04-30

Brief Summary

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.

Detailed 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.

Conditions

Diet; Autophagy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

FMD1-ProLon

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

Group Type: EXPERIMENTAL

Fasting Mimicking Diet

Intervention Type: COMBINATION_PRODUCT

FMD is a 5-day low calorie fasting-mimicking diet.

FMD2-ProMete

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

Group Type: EXPERIMENTAL

Fasting Mimicking Diet

Intervention Type: COMBINATION_PRODUCT

FMD is a 5-day low calorie fasting-mimicking diet.

Interventions

Fasting Mimicking Diet

FMD is a 5-day low calorie fasting-mimicking diet.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

ProLon, ProMete

Eligibility Criteria

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);

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: collaborator

L-Nutra Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sara Espinoza, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Countries

United States

Other Identifiers

LNT22-017

Identifier Type: -

Identifier Source: org_study_id