AzTrials
AzTrials

Prostate CancerNCT04292041

Fasting Mimicking Diet in Prostate Cancer and Metabolic Syndrome

An observational study of Prostate Cancer and Metabolic Syndrome, run by Galway Clinic at 1 site in Ireland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Any age, men only
What is being tested?
Fasting mimicking diet
How many people
40 participants
Where
1 siteIreland
Study dates
15 Jan 2019to 15 Jun 2020
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • Galway Clinic

    Galway

Other trials in Ireland

About this study

Official title: 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.

Read the 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.

Being tested
Fasting mimicking diet
Keywords
Fasting Mimicking Diet
Medical subject headings
Prostatic Neoplasms, Metabolic Syndrome, Intermittent Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fasting mimicking dietOther

    Also called Programmed cyclic nutrition for 3 monthly cycles (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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Baseline Weight (in kilograms) at 6 months

    Metabolic health parameter

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

  2. Change in Baseline Blood Pressure (in millimeters of Mercury) at 6 months

    Metabolic health parameter

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

  3. Change in Baseline Waist Circumference (in centimeters) at 6 months

    Metabolic health parameter

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

  4. Change in Baseline Triglycerides Level (in millimoles per litre) at 6 months

    Clinical lab results

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

  5. Change in Baseline Total, LDL, and HDL Cholesterol (in millimoles per litre) at 6 months

    Clinical lab results

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

Secondary outcomes (3)

  1. 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 -

    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

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

  2. 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

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

  3. 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

    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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2020
  2. Study start15 Jan 2019
  3. Primary completion15 Jun 2020 (estimated)
  4. Study completion15 Jun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04292041
Sponsor's protocol ID
GalwayC
Status last verified
Feb 2020
First submitted
21 Feb 2020
Last updated
2 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: None planned

Publications

  • 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.

    PubMed 31728501

  • 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.

    PubMed 20395504

  • 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.

    PubMed 25153840

  • 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.

    PubMed 35314788

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer and Metabolic Syndrome, run by Galway Clinic at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04292041, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in