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Fasting Mimicking Diet in Prostate Cancer and Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04292041
Recruitment Status : Active, not recruiting
First Posted : March 2, 2020
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
Professor Frank Sullivan, Galway Clinic

Tracking Information
First Submitted Date February 21, 2020
First Posted Date March 2, 2020
Last Update Posted Date March 2, 2020
Actual Study Start Date January 15, 2019
Estimated Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 28, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 28, 2020)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fasting Mimicking Diet in Prostate Cancer and Metabolic Syndrome
Official Title Fasting Mimicking Diet in Prostate Cancer and Metabolic Syndrome, a Pilot Study
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Not Provided
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.
Condition
  • Prostate Cancer
  • Metabolic Syndrome
  • Intermittent Fasting
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.
Other Name: Programmed cyclic nutrition for 3 monthly cycles (fasting mimicking diet)
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: February 28, 2020)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 15, 2020
Estimated Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Ireland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04292041
Other Study ID Numbers GalwayC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: None planned
Responsible Party Professor Frank Sullivan, Galway Clinic
Study Sponsor Galway Clinic
Collaborators Not Provided
Investigators
Principal Investigator: Frank Sullivan, MSc Galway Clinic
PRS Account Galway Clinic
Verification Date February 2020