Fasting Mimicking Diet in Prostate Cancer and Metabolic Syndrome

Prostate Cancer Clinical Trial

Official title:

Fasting Mimicking Diet in Prostate Cancer and Metabolic Syndrome, a Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04292041
• Other study ID #: GalwayC
• Status: Active, not recruiting
• Start date: January 15, 2019
• Est. completion date: June 15, 2020

Study information

• Verified date: February 2020
• Source: Galway Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 15, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Intermittent Fasting
• Metabolic Syndrome
• Prostate Cancer
• Prostatic Neoplasms
• Syndrome

Intervention

Other:
• Fasting mimicking diet
3 cycles of programmed nutrition using a fasting mimicking diet (Chemolieve (R)), each cycle consisting of 4 days. Pre and post nutritional cycles, clinical and metabolic assessments are taken, as per protocol. Allowing for a 3 month "washout" time, the 'post' assessment is planned approximately 6 months from the initial (pre) assessment.

Locations

Country	Name	City	State
Ireland	Galway Clinic	Galway

Sponsors (1)

Lead Sponsor	Collaborator
Galway Clinic

Country where clinical trial is conducted

Ireland, 

References & Publications (3)

Brandhorst S, Longo VD. Protein Quantity and Source, Fasting-Mimicking Diets, and Longevity. Adv Nutr. 2019 Nov 1;10(Supplement_4):S340-S350. doi: 10.1093/advances/nmz079. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Baseline Weight (in kilograms) at 6 months	Metabolic health parameter	Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
Primary	Change in Baseline Blood Pressure (in millimeters of Mercury) at 6 months	Metabolic health parameter	Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
Primary	Change in Baseline Waist Circumference (in centimeters) at 6 months	Metabolic health parameter	Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
Primary	Change in Baseline Triglycerides Level (in millimoles per litre) at 6 months	Clinical lab results	Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
Primary	Change in Baseline Total, LDL, and HDL Cholesterol (in millimoles per litre) at 6 months	Clinical lab results	Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
Secondary	Change in Baseline EQ5D5L Health Questionnaire Score at 6 months	Structured Quality of Life Measure - Patients' self report of mobility, self-care, usual activities, pain/discomfort, anxiety/depression -; No problem; Slight problems; Moderate problems; Severe problems; Unable to/extreme problems; 5 questions; Minimum score of 0, meaning good quality of life; Maximum score of 25, meaning poor quality of life	Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
Secondary	Change in Baseline EQ5D5L Vertical Visual Analogue Scale Score at 6 months	Structured Quality of Life Measure - Patients' self report on how good/bad their health is TODAY -; One scale numbered from 0 to 100; Minimum score of 0, meaning the worst health you can imagine; Maximum score of 100, meaning the best health you can imagine	Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
Secondary	Change in Baseline Chalder Fatigue Index Score at 6 months	Structured Tiredness/Fatigue Measures on Likert Scale - Patients' self report of fatigue symptoms -; 0: Less than usual; No more than usual; More than usual; Much more than usual; 6 questions; minimum score of 0, meaning no fatigue due to illness; maximum score of 18, meaning chronic fatigue due to illness	Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months