Fasting Mimicking Diet in Prostate Cancer and Metabolic Syndrome

NCT ID: NCT04292041

Last Updated: 2020-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2020-06-15

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.

Conditions

Prostate Cancer; Metabolic Syndrome; Intermittent Fasting

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Programmed cyclic nutrition for 3 monthly cycles (fasting mimicking diet)

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Galway Clinic

NETWORK

Sponsor Role: lead

Responsible Party

Professor Frank Sullivan

Medical Director, Department of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Sullivan, MSc

Role: PRINCIPAL_INVESTIGATOR

Galway Clinic

Locations

Galway Clinic

Galway, , Ireland

Countries

Ireland

References

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.

Reference Type: RESULT

PMID: 31728501 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20395504 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25153840 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35314788 (View on PubMed)

Other Identifiers

GalwayC

Identifier Type: -

Identifier Source: org_study_id