Fasting Mimicking Diet in Prostate Cancer and Metabolic Syndrome

February 28, 2020 updated by: Professor Frank Sullivan, Galway Clinic

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Galway, Ireland
        • Galway Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Baseline Weight (in kilograms) at 6 months
Time Frame: Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 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
Time Frame: Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 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
Time Frame: Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 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
Time Frame: Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 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
Time Frame: Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
Clinical lab results
Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Baseline EQ5D5L Health Questionnaire Score at 6 months
Time Frame: Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months

Structured Quality of Life Measure - Patients' self report of mobility, self-care, usual activities, pain/discomfort, anxiety/depression -

  1. No problem
  2. Slight problems
  3. Moderate problems
  4. Severe problems

  5. 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
Change in Baseline EQ5D5L Vertical Visual Analogue Scale Score at 6 months
Time Frame: Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 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
Change in Baseline Chalder Fatigue Index Score at 6 months
Time Frame: Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months

Structured Tiredness/Fatigue Measures on Likert Scale - Patients' self report of fatigue symptoms -

0: Less than usual

  1. No more than usual
  2. More than usual

  3. 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galway Clinic

Investigators

  • Principal Investigator: Frank Sullivan, MSc, Galway Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Anticipated)

June 15, 2020

Study Completion (Anticipated)

June 15, 2020

Study Registration Dates

First Submitted

February 21, 2020

First Submitted That Met QC Criteria

February 28, 2020

First Posted (Actual)

March 2, 2020

Study Record Updates

Last Update Posted (Actual)

March 2, 2020

Last Update Submitted That Met QC Criteria

February 28, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GalwayC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

None planned

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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