Clinical trial · Observational
Fasting Mimicking Diet in Prostate Cancer and Metabolic Syndrome
Fasting Mimicking Diet in Prostate Cancer and Metabolic Syndrome, a Pilot Study
NCT04292041CI-TRIAL-00043717unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective observational cohort study of patients with prostate cancer who have a metabolic syndrome. The study aims to evaluate the role of intermittent fasting (fasting mimicking diet) in these patients. The primary end point is metabolic health and the secondary endpoint is quality of life.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intermittent Fasting | — | UNRESOLVED | — |
| Metabolic Syndrome | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fasting mimicking diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Change in Baseline Weight (in kilograms) at 6 months
- timeFrame
- Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
- description
- Metabolic health parameter
- measure
- Change in Baseline Blood Pressure (in millimeters of Mercury) at 6 months
- timeFrame
- Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
- description
- Metabolic health parameter
- measure
- Change in Baseline Waist Circumference (in centimeters) at 6 months
- timeFrame
- Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
- description
- Metabolic health parameter
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Patients with biopsy-proven prostate cancer having features of a metabolic syndrome, receiving standard treatment options for their disease. Exclusion Criteria: * Patients without a diagnosis of prostate cancer * Life expectancy less than 1 year * Children under the age of 18 * Individuals who are allergic to nuts or soy * Individuals with a Body Mass Index (BMI) \<18.5 * Individuals who have been severely weakened by a disease or medical procedure * Individuals who are taking medications which may not be safely consumed with a calorie restricted diet unless authorised in writing by a licensed physician * Individuals with a history of significant cardiac disease, particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF \<40% on any prior assessment * Individuals with a history of syncope (fainting) with calorie restriction or other medical co-morbidities * Individuals who have special dietary needs that are incompatible with the ProLon® meal plan * Individuals with liver or kidney disorders that may be affected by the very low glucose and protein content of the diet
References
Publications (4)
- RESULTBrandhorst S, Longo VD. Protein Quantity and Source, Fasting-Mimicking Diets, and Longevity. Adv Nutr. 2019 Nov 1;10(Suppl_4):S340-S350. doi: 10.1093/advances/nmz079. PMID 31728501
- RESULTFontana L, Partridge L, Longo VD. Extending healthy life span--from yeast to humans. Science. 2010 Apr 16;328(5976):321-6. doi: 10.1126/science.1172539. PMID 20395504
- RESULTMirzaei H, Suarez JA, Longo VD. Protein and amino acid restriction, aging and disease: from yeast to humans. Trends Endocrinol Metab. 2014 Nov;25(11):558-66. doi: 10.1016/j.tem.2014.07.002. Epub 2014 Aug 19. PMID 25153840
- DERIVEDFay-Watt V, O'Connor S, Roshan D, Romeo AC, Longo VD, Sullivan FJ. The impact of a fasting mimicking diet on the metabolic health of a prospective cohort of patients with prostate cancer: a pilot implementation study. Prostate Cancer Prostatic Dis. 2023 Jun;26(2):317-322. doi: 10.1038/s41391-022-00528-3. Epub 2022 Mar 21. PMID 35314788