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FMD for Intermittent Fasting

N/A

Recruiting

Led By Jonathan D Boone

Research Sponsored by L-Nutra Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate renal function (serum creatinine less than 1.5 times the upper limit of normal)

Age 35-70 years old (both inclusive)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0, week12, week 21

Awards & highlights

Study Summary

"This trial looks at how changes in lifestyle can help manage side effects of chemotherapy in patients with gynecologic cancers."

Who is the study for?

This trial is for patients with gynecologic cancers such as ovarian cancer, who are undergoing chemotherapy. It's designed to see if a special diet that mimics fasting can help manage the side effects of their treatment.Check my eligibility

What is being tested?

The study is testing whether a Fasting Mimicking Diet alongside standard chemotherapy can reduce the negative side effects associated with chemo in patients with gynecologic malignancies.See study design

What are the potential side effects?

Potential side effects may include those typically associated with chemotherapy, such as nausea, fatigue, hair loss, and increased risk of infection. The diet itself may cause feelings of hunger, weakness or dizziness due to calorie restriction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is within the normal range.

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I am between 35 and 70 years old.

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My cancer diagnosis was confirmed with a biopsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0, week12, week 21

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0, week12, week 21

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, week12, week 21 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Quality of life by National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index (NFOSI-18) questionnaire

Rate of Adherence

Secondary outcome measures

Change in Body Composition

Change in Body Weight

Change in Fasting Glucose Concentration

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FMDExperimental Treatment2 Interventions

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

Group II: ControlActive Control1 Intervention

Subjects will receive the standard care and no dietary changes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chemotherapy

2003

Completed Phase 4

~3050

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

L-Nutra IncLead Sponsor

8 Previous Clinical Trials

634 Total Patients Enrolled

University of Tennessee Medical CenterOTHER

5 Previous Clinical Trials

257 Total Patients Enrolled

Jonathan D BoonePrincipal InvestigatorThe University of Tennessee Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 50 and above eligible to participate in this medical investigation?

"To meet the enrollment criteria for this research, individuals must be at least 35 years old but no older than 70."

Answered by AI

Is the enrollment for this study currently accepting new participants?

"According to details on clinicaltrials.gov, this clinical investigation is presently enrolling participants. The trial was originally made available on September 8th, 2021 and its most recent update was recorded on April 18th, 2024."

Answered by AI

How many individuals are currently enrolled in this clinical investigation?

"Yes, data available on clinicaltrials.gov confirms that this study is actively enrolling participants. The trial was first posted on September 8th, 2021 and last modified on April 18th, 2024. Recruitment aims to secure 30 candidates from a single site."

Answered by AI

What are the anticipated results that researchers hope to achieve through conducting this study?

"During the Week 0-21 period, this study will primarily evaluate participants' quality of life using the NFOSI-18 questionnaire. Secondary assessments involve monitoring alterations in leptin concentration (blood levels), deviations from scheduled chemotherapy regimens, and fluctuations in body weight."

Answered by AI

Recent research and studies

BMC Complementary and Alternative MedicineJournal

Is Fasting Safe? A Chart Review of Adverse Events During Medically Supervised, Water-only Fasting

Finnell, John S., Bradley C. Saul, Alan C. Goldhamer, and Toshia R. Myers. 2018. “Is Fasting Safe? A Chart Review of Adverse Events During Medically Supervised, Water-only Fasting”. BMC Complementary and Alternative Medicine. Springer Science and Business Media LLC. doi:10.1186/s12906-018-2136-6.

clinicaltrials.govStudy

Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies

2021. "Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06376604.

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