Clinical trial NCT04292041: Fasting Mimicking Diet in Prostate Cancer and Metabolic Syndrome
Official title: Fasting Mimicking Diet in Prostate Cancer and Metabolic Syndrome, a Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Metabolic Syndrome
Intermittent Fasting
Keywords: Fasting Mimicking Diet
Lead sponsor: Galway Clinic
Sponsor class: NETWORK
First posted: 2020-03-02
Enrollment: 40
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort of 40 men with biopsy-proven prostate cancer having features of a metabolic syndrome, receiving standard treatment options for their disease.

Brief summary: 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.

Detailed description: Cancer is a complex set of conditions which collectively comprise the second biggest cause of death in the western world. In addition, these diseases, along with their various treatments, are associated with significant illness, as well as a host of debilitating symptoms. Two very common problems are cancer fatigue, as well as metabolic changes which can cause much suffering in and of themselves. Patients with advanced cancers, as well as many patients undergoing surgery, radiation therapy as well as chemotherapy all complain of fatigue, to a greater or lesser extent. Many gain or lose weight, and develop associated metabolic changes in uninvolved body systems, which can cause a significant health burden on the patients, as well as the healthcare system as a whole.

Little is known about the mechanisms which underlie these symptoms. Various biologic processes have been implicated including inflammation and other changes in body metabolism. There is urgent need to better understand these processes, which cause so much suffering in cancer patients, so as to potentially develop more effective solutions.

Eligibility criteria: 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

Primary outcomes:
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
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
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
measure: Change in Baseline Triglycerides Level (in millimoles per litre) at 6 months
timeFrame: Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
measure: Change in Baseline Total, LDL, and HDL Cholesterol (in millimoles per litre) at 6 months
timeFrame: Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
Secondary outcomes:
measure: Change in Baseline EQ5D5L Health Questionnaire Score at 6 months
timeFrame: Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
measure: Change in Baseline EQ5D5L Vertical Visual Analogue Scale Score at 6 months
timeFrame: Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
measure: Change in Baseline Chalder Fatigue Index Score at 6 months
timeFrame: Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: Galway Clinic
Study officials:
affiliation: Galway Clinic
name: Frank Sullivan, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brandhorst 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.
citation: Fontana 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.
citation: Mirzaei 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.
citation: Fay-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.