Clinical trial NCT06115551: Fasting Mimicking Diet and Autophagy
Official title: Cellular Effects of Fasting Mimicking Diet In Humans: An Interventional, Randomized, Open Label, Parallel Assignment Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diet
Autophagy
Keywords: Fasting mimicking diet
Lead sponsor: L-Nutra Inc
Sponsor class: INDUSTRY
Collaborators: name: The University of Texas Health Science Center at San Antonio
First posted: 2023-11-03
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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);

Primary outcomes:
measure: Autophagy flux
timeFrame: Baseline to day 8
Secondary outcomes:
measure: Metabolomic change
timeFrame: Baseline to day 8
measure: Autophagy-related gene expression
timeFrame: Baseline to day 8
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Sara Espinoza, MD
role: PRINCIPAL_INVESTIGATOR
References: