Fasting Mimicking Diet and Autophagy

Cellular Effects of Fasting Mimicking Diet In Humans: An Interventional, Randomized, Open Label, Parallel Assignment Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diet; Autophagy
• Intervention / Treatment: Combination product: Fasting Mimicking Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Espinoza, MD; Phone Number: 210-617-5197; Email: espinozas2@uthscsa.edu

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • The University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Subjects in the control group will be asked to keep their normal diet during the study period.
Experimental: FMD1-ProLon; Subjects in FMD1 groups will be provided and asked to consume a 5-day low calorie fasting-mimicking diet (ProLonTM).	Combination product: Fasting Mimicking Diet; FMD is a 5-day low calorie fasting-mimicking diet.; Other Names: ProLon, ProMete
Experimental: FMD2-ProMete; Subjects in FMD2 groups will be provided and asked to consume a 5-day low calorie fasting-mimicking diet (ProMeteTM).	Combination product: Fasting Mimicking Diet; FMD is a 5-day low calorie fasting-mimicking diet.; Other Names: ProLon, ProMete

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autophagy flux	PBMCs will be prepared with or without Chloroquine (autophagy flux inhibitor). LC3BI to LC3BII conversion, the lipidation of MAP1LC3B/LC3B (microtubule-associated protein 1 light chain 3 β), in the PBMCs will be accessed by western blot. Autophagy-dependent degradation of SQSTM1/p62, a receptor and scaffold protein interacting with LC3 and ubiquitinated proteins, will be accessed by western blot.	Baseline to day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolomic change	Plasma will be analyzed by high throughput RNA sequencing for gene expression changes.	Baseline to day 8
Autophagy-related gene expression	PBMCs will be prepared with or without Chloroquine (autophagy flux inhibitor). PBMC RNA samples will be analyzed using ultra high-performance liquid chromatography/tandem accurate mass spectrometry (UHPLC/MS/MS).	Baseline to day 8

Collaborators and Investigators

• Sponsor: L-Nutra Inc
• Collaborators: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Sara Espinoza, MD, The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 29, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Fasting mimicking diet
• Other Study ID Numbers: LNT22-017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No