An interventional study of Fasting Mimicking Diet in Diet and Autophagy, sponsored by L-Nutra Inc. Active, not recruiting at 1 site in United States. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by L-Nutra Inc · Not applicable, Interventional, and Other
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.
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.
L-Nutra Inc is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects in the control group will be asked to keep their normal diet during the study period.
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
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.
Also known as: ProLon, ProMete
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.
Time frame: Baseline to day 8
Metabolomic change
Plasma will be analyzed by high throughput RNA sequencing for gene expression changes.
Time frame: 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).
Time frame: Baseline to day 8
This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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L-Nutra Inc