Fasting Mimicking Diet and Autophagy

NCT06115551 | Active Not Recruiting

• 1 other identifier: LNT22-017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet; Autophagy

Keywords

Fasting mimicking diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Metabolomic change

  Baseline to day 8

• Autophagy-related gene expression

  Baseline to day 8

Study Arms (3)

Control

NO INTERVENTION

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

FMD1-ProLon

EXPERIMENTAL

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

FMD2-ProMete

EXPERIMENTAL

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

Interventions

Fasting Mimicking Diet COMBINATION_PRODUCT

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

Also known as: ProLon, ProMete

FMD1-ProLon; FMD2-ProMete

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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);

Sponsors & Collaborators

• L-Nutra Inc: lead
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Espinoza SE, Park S, Connolly G, Qi W, Zhang N, Semwal M, Li Y, Lauzon M, Salmon AB, Hsu W, Wei M, Musi N. Effect of fasting-mimicking diet on markers of autophagy and metabolic health in human subjects. Geroscience. 2025 Dec 11. doi: 10.1007/s11357-025-02035-4. Online ahead of print.

  PMID: 41372565 DERIVED

Study Officials

• Sara Espinoza, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 3, 2023
• Study Start: May 2, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

US (1)