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Search / Trial NCT06376604

Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies

Launched by L-NUTRA INC · Apr 18, 2024

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Fasting Mimicking Diet Gynecologic Malignancy Chemotherapy

ClinConnect Summary

This clinical trial is exploring how a special diet, called a fasting mimicking diet, can help women undergoing chemotherapy for gynecologic cancers, such as ovarian cancer. The goal is to see if this diet can reduce the side effects of chemotherapy and improve the overall experience for patients. The study is currently looking for women between the ages of 35 and 70 who have been diagnosed with a gynecologic cancer and are scheduled to undergo at least six more cycles of chemotherapy.

To participate, women need to meet certain criteria, including having a body mass index (BMI) of at least 18.5 and good kidney function. However, some individuals may not be eligible, such as those who are pregnant, have diabetes, or have severe heart or kidney issues. Participants can expect to follow a 5-day diet that mimics fasting, which means they will consume specially designed meals that provide fewer calories while still providing essential nutrients. This study is a chance to contribute to important research that could help improve the treatment experience for others in similar situations.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Women
  • Age 35-70 years old (both inclusive)
  • Biopsy proven gynecologic malignancy
  • Scheduled to or currently undergoing chemotherapy, with a minimum of 6 cycles remaining
  • BMI greater than or equal to 18.5
  • Adequate renal function (serum creatinine less than 1.5 times the upper limit of normal)
  • Willing to adhere to a 5-day fasting mimicking diet
  • Exclusion Criteria:
  • Pregnant or nursing mothers
  • Prisoners
  • Patients with diabetes or history of hypoglycemia
  • Taking daily medications that cannot be safely taken without food
  • History of significant or unstable cardiac disease such as congestive heart failure or history of myocardial infarction, stroke or pulmonary embolism within the last 3 months, renal failure, history of - eating disorder, dementia, psychosis, impaired physical mobility.
  • Significant medical comorbidity that would be dangerous with a fasting mimicking diet.
  • Any known or suspected food allergies that overlap with the FMD/Transitional diet by L-Nutra meal kit ingredients.

About L Nutra Inc

L-Nutra Inc. is a pioneering biotechnology company focused on advancing nutrition-based therapies to promote health and longevity. With a strong emphasis on scientific research and innovation, L-Nutra develops proprietary dietary solutions that target metabolic health and support the body's natural regenerative processes. The company is committed to transforming healthcare through evidence-based dietary interventions, aiming to improve patient outcomes and enhance quality of life. By leveraging cutting-edge research and clinical trials, L-Nutra strives to establish the therapeutic potential of fasting and other nutritional strategies in managing chronic diseases and optimizing overall wellness.

Locations

Knoxville, Tennessee, United States

Patients applied

0 patients applied

Trial Officials

Jonathan D Boone

Principal Investigator

The University of Tennessee Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported