Fasting Mimicking Diet and Autophagy

• Sponsor: L-Nutra Inc (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT06115551
• Collaborator: The University of Texas Health Science Center at San Antonio (Other)
• Enrollment: 30
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 7.5
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diet; Autophagy	Combination Product: Fasting Mimicking Diet	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Cellular Effects of Fasting Mimicking Diet In Humans: An Interventional, Randomized, Open Label, Parallel Assignment Study
• Actual Study Start Date: May 2, 2023
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Dec 15, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Autophagy flux [Baseline to day 8]

   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.

Secondary Outcome Measures

1. Metabolomic change [Baseline to day 8]

   Plasma will be analyzed by high throughput RNA sequencing for gene expression changes.

2. Autophagy-related gene expression [Baseline to day 8]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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);

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• L-Nutra Inc
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: L-Nutra Inc
• ClinicalTrials.gov Identifier: NCT06115551
• Other Study ID Numbers: LNT22-017
• First Posted: Nov 3, 2023
• Last Update Posted: Nov 3, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by L-Nutra Inc: Fasting mimicking diet

Study Results

No Results Posted as of Nov 3, 2023