Safety, Feasibility and Metabolic Effects of the Fasting Mimicking Diet (FMD) in Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03340935|
Recruitment Status : Active, not recruiting
First Posted : November 14, 2017
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm Cancer||Other: Fasting mimicking diet||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||85 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety, Feasibility and Metabolic Effects of the Fasting Mimicking Diet (FMD) in Cancer Patients|
|Actual Study Start Date :||February 1, 2017|
|Actual Primary Completion Date :||March 30, 2019|
|Estimated Study Completion Date :||April 30, 2019|
Experimental: Fasting mimicking diet
Fasting mimicking diet (FMD)
Other: Fasting mimicking diet
Fasting Mimicking Diet (or FMD) consists in a 5-day plant-based, low-calorie (600 Kcal on day 1, followed by 300 KCal/day on days 2 to 5), low-protein, low carbohydrate diet
- Safety of the fasting mimicking diet (FMD) in cancer patients [ Time Frame: 2 years ]Safety is assessed by recording each adverse (AE) occurring during the period on diet. All AEs will be graded according to the NCI CTCAE v 4.03. Serious adverse events (SAEs) will be also reported.
- Feasibility of the FMD in cancer patients [ Time Frame: 16 months ]Feasibility is defined as the ability of the patient to comply with the prescribed dietary regimen. It will be assessed through the analysis of food diaries filled by patients during the five days of each FMD cycle.
- Metabolic effects of the FMD [ Time Frame: 16 months ]FMD-induced metabolic changes will be evaluated by measuring blood metabolites (glucose, cholesterol, triglycerides) and urinary ketone bodies before and at the completion of each FMD cycle.
- Effects of the FMD on blood growth factors [ Time Frame: 16 months ]FMD-induced changes in blood growth factors will be evaluated by measuring modifications of plasma insulin and serun insulin-like growth factor 1 (IGF-1) concentration before and at the completion of each FMD cycle
- Weight changes during the FMD [ Time Frame: 16 months ]Percent changes in body weight will be measured during each FMD cycle and across subsequent FMD cycles.
- Changes in blood cell counts [ Time Frame: 16 months ]FMD-induced changes in blood cell counts
- Changes in kidney function parameters. [ Time Frame: 16 months ]FMD-induced changes in parameters linked to kidney function, such as blood urea nitrogen, creatinine and uric acid.
- Changes in liver parameters [ Time Frame: 16 months ]FMD-induced changes in parameters linked to liver function, such as aspartate and alanine transaminases, total bilirubin.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340935
|Fondazione IRCCS Istituto Nazionale dei Tumori|
|Milan, Italy, 20133|
|Principal Investigator:||Filippo de Braud, M.D.||SC Oncologia Medica 1, Fondazione IRCCS Istituto Nazionale dei Tumori|