Fasting Mimicking Diet in Prostate Cancer and Metabolic Syndrome

NCT04292041 | Unknown

• 1 other identifier: GalwayC
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Metabolic Syndrome; Intermittent Fasting

Keywords

Fasting Mimicking Diet

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Change in Baseline EQ5D5L Health Questionnaire Score at 6 months

  Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months

• Change in Baseline EQ5D5L Vertical Visual Analogue Scale Score at 6 months

  Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months

• Change in Baseline Chalder Fatigue Index Score at 6 months

  Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months

Interventions

Fasting mimicking diet OTHER

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.

Also known as: Programmed cyclic nutrition for 3 monthly cycles (fasting mimicking diet)

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with biopsy-proven prostate cancer having features of a metabolic syndrome, receiving standard treatment options for their disease.

You may not qualify if:

• 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

Sponsors & Collaborators

• Galway Clinic: lead

Study Sites (1)

Galway Clinic

Galway, Ireland

Location

Related Publications (4)

• 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.

  PMID: 31728501 RESULT

• 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.

  PMID: 20395504 RESULT

• 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.

  PMID: 25153840 RESULT

• 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.

  PMID: 35314788 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Metabolic Syndrome; Intermittent Fasting

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fasting; Feeding Behavior; Behavior

Study Officials

• Frank Sullivan, MSc

  Galway Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Department of Radiation Oncology

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: March 2, 2020
• Study Start: January 15, 2019
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: March 2, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)