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| Name | Class |
|---|---|
| The University of Texas Health Science Center at San Antonio | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| FMD2-ProMete | Experimental | Subjects in FMD2 groups will be provided and asked to consume a 5-day low calorie fasting-mimicking diet (ProMeteTM). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting Mimicking Diet | Combination Product | FMD is a 5-day low calorie fasting-mimicking diet. |
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| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Espinoza, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41372565 | Derived | 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. |
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| Baseline to day 8 |