Recruiting

Fasting Mimicking Diet

Sponsor:

L-Nutra Inc

Code:

NCT06376604

Conditions

Cancer, Ovarian

Chemotherapy Effect

Calorie Deficiency

Fasting, Intermittent

Eligibility Criteria

Sex: Female

Age: 35 - 70

Healthy Volunteers: Not accepted

Interventions

Fasting Mimicking Diet

Chemotherapy

Study Details

Brief summary:

This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies.

Conditions

Cancer, Ovarian

Chemotherapy Effect

Calorie Deficiency

Fasting, Intermittent

Study ID

NCT06376604

Start date

Sep 8, 2021

Status verified date

Apr, 2024

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Sep 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 35 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: FMD

In addition to the standard care, subject will consume a 5-day fasting mimicking diet.

active comparator: Control

Subjects will receive the standard care and no dietary changes.

Interventions

Fasting Mimicking Diet

Subject will consume 6 cycles of 5-day fasting mimicking diet: 3 days prior to, the day of, and 1 day following chemotherapy treatments.

Chemotherapy

6 cycles of standard chemotherapy for the gynecologic malignancy.

Primary outcome measure

  • Quality of life by National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index (NFOSI-18) questionnaire [ Time Frame: Week 0-21 ]
  • Rate of Adherence [ Time Frame: Week 0-21 ]

Central Contacts and Locations

Central contacts

Min Wei, PhD

323.791.2426mwei@l-nutra.com

Jonathan D Boone, MD

8653055622jboone@utmck.edu

Locations

The University of Tennessee Medical Center

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Jonathan D Boone, MD

865-305-5622jboone@utmck.edu

More Information

Sponsor

L-Nutra Inc

Last update posted

Apr 19, 2024

Last verified

Apr, 2024

Keywords

  • Fasting mimicking diet
  • Gynecologic malignancy
  • Chemotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by L-Nutra Inc on 2024-04-19.