RightFit
RecruitingPhase 2

Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 days, 6 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The fasting mimicking diet will be consumed for 5 days per month for a total of 6 months and will be monitored by trained research dietitians."
  • "This study aims to examine the effects of a fasting mimicking diet (5 days per month eating L-Nutra products only for 6 months) vs. usual diet on response to cancer treatment of metastatic castrate sensitive prostate adenocarcinoma."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a diet that mimics fasting helps prostate cancer treatment work better than a usual diet. It is for men whose prostate cancer has spread and still responds to treatment that lowers male hormones. Everyone gets standard cancer care; the fasting diet group eats only L-Nutra products for 5 days each month for 6 months, with guidance from study dietitians.

This is a Phase 2, randomized two-armed, multi-site study of 138 patients with metastatic castrate sensitive prostate adenocarcinoma. Patients will be randomized 1:1 to receive the fasting mimicking diet, or usual diet. All patients will receive standard of care treatment for their prostate cancer. The fasting mimicking diet will be consumed for 5 days per month for a total of 6 months and will be monitored by trained research dietitians. This study aims to examine the effects of a fasting mimicking diet (5 days per month eating L-Nutra products only for 6 months) vs. usual diet on response to cancer treatment of metastatic castrate sensitive prostate adenocarcinoma.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have prostate cancer called adenocarcinoma, confirmed by a tissue sample, that still responds to hormone-lowering treatment.
  • Have cancer that has spread, confirmed by a tissue sample or MRI scan.
  • Receive or plan to start first-line hormone-lowering treatment within 30 days of signing up, with abiraterone, apalutamide, enzalutamide, or darolutamide. Current or past chemotherapy is allowed.
  • Read, write, and understand English or Spanish, and have phone access to speak with the study dietitian.
  • Sign a consent form and be able to follow the study requirements.

Who can't join

  • Have an allergy to any ingredient on the Xentigen Ingredient List.
  • Have diabetes without stable doses of blood sugar medicine for at least 6 months and without a doctor's approval to safely pause that medicine during the 5 fasting-diet days.
  • Already follow a fasting diet that the study doctor thinks would affect participation.
  • Have serious health problems, such as heart, lung, or liver disease, or ongoing alcohol or drug abuse, that the study doctor thinks would prevent participation.
  • Have a body mass index (BMI), a measure of weight compared with height, below 20.
  • Are trying to lose weight, take weight-loss medicine, or plan to have weight-loss surgery in the next 6 months.
  • Report losing 10% or more of your body weight in the last 6 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Metastatic castrate sensitive prostate adenocarcinoma (Adenocarcinoma prostate histologically confirmed by biopsy AND Metastatic disease confirmed biopsy, or MRI scan) * Men receiving or planning to start first-line intensified ADT (within 30 days of registration) with abiraterone, apalutamide, enzalutamide, or darolutamide with or without current or prior chemotherapy * Reads, writes, and understands English or Spanish and has telephone access for remote contact with the study dietitian. * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: * Allergies to any ingredients listed on the Xentigen Ingredient List * Men with diabetes who are not on stable doses of antihyperglycemic medication for at least 6 months and without physician consent that they may safely hold antihyperglycemic medication during the 5 days of FMD * Regularly practicing a fasting diet that in the opinion of the study physician would impact study participation * Significant co-morbidities (i.e., cardiac, pulmonary, liver disease, ongoing alcohol/drug abuse) that in the opinion of the study physician would preclude enrollment in this study. * Body Mass Index (BMI) \<20kg/m2 * Men actively trying to lose weight OR on weight loss medications (including but not limited to Contrave, Saxenda, Xenical) or planning to receive weight loss surgery in the next six months * Self-reported weight loss ≥ 10% in the last 6 months

Study sites (3)

CA

NC