ONGOING, PLANNED AND COMPLETED CLINICAL TRIALS.

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Cardiometabolic Clinical Trials
Disease State
Leading University
ONGOING

Overweight/Obesity-Associated Olfact Deficit And FMD. ITER Center for Balance and Rehabilitation Research (ICBRR), Department of Clinical Sciences and Translational Medicine - ENT Unit, University of Rome Tor Vergata.

Obesity
University of Rome Tor Vergata

Phase I, Pilot, Randomized, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Promet, A Fasting-Mimicking Diet, On Inflammatory (FMDiCMP Study) Cardiomyopathy. (DRKS00019898) Heart Failure and Cardiomyopathies, Charité Universitätsmedizin Berlin, Campus Benjamin Franklin.

Inflammatory Cardiomyopathy
Charité University, Berlin
COMPLETED

Evaluation of a Fasting Mimicking Diet and the Effect on Endothelial Function, Body Composition and Vascular Markers. (NCT04150159) Hypertension Institute (HI) of Nashville, and USC (University of Southern California).

Hypertension
Hypertension Institute + University of Southern California

Clinical Feasibility And Efficacy Of Intermittent Use Of A Fasting Mimicking Diet In The Treatment Of Type 2 Diabetes Fasting in Diabetes Treatment (FIT) study. (NCT03811587). Leiden University Medical Centre, The Netherlands.

Type 2 Diabetes Mellitus
Leiden University Medical Centre

Chronic Fasting And The Late Complications Of Diabetes: A Prospective Exploratory Randomized Controlled Study In Patients With Diabetes Mellitus Type 2. (DRKS00014287) Department of Endocrinology and Clinical Chemistry (Internal Medicine I), University Hospital Heidelberg, Heidelberg, Germany.

Type 2 Diabetes Mellitus
University Hospital Heidelberg

Dietary Interventions To Improve The Microvascular Health In South Asian Patients With Early Diabetic Nephropathy (Glycotreat Study) (NCT03889236). Leiden University Medical Centre, The Netherlands.

Diabetic Nephropathy
Leiden University Medical Centre

Primitive Glomerulonephritis And Chronic Kidney Disease In Conservative Therapy With EGFR ≤ 60 ML/MIN (3 STAGE KDOQI) Sapienza University, Rome, Italy.

CKD
Sapienza University, Rome

Effect of a Periodic Fasting-mimicking Diet on Risk Factors for Metabolic Syndrome and Age-related Diseases. University of Southern California. (NCT02158897)
PUBLISHED Brandhorst S et al. Cell. (2015).
PUBLISHED Wei M et al. Sci Transl Med. (2017)

Healthy Individuals
University of Southern California
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Oncology Clinical Trials
Disease State
Leading University
ONGOING

Impact Of Dietary Intervention On Tumor Immunity: The DigesT Trial (DigesT) (NCT03454282) Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.

Breast Cancer and Melanoma
Leiden University Medical Centre

Exploiting Metformin Plus/Minus Cyclic Fasting Mimicking Diet (FMD) to Improve the Efficacy of Platinum-pemetrexed Chemotherapy in Advanced LKB1-inactive Lung Adenocarcinoma: the FAME Trial. (NCT03709147) Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.

Lung Cancer
IRCCS National Tumor Institute, Milan

0S-10-3 A Randomized, Phase Ii Clinical Trial Of A Controlled Diet Prior To Selected Chemotherapy Treatment In Breast And Prostate Cancer, To Evaluate The Impact On Toxicity And Efficacy. (NCT01802346) USC in collaboration with Norris Cancer Center and LAC+USC.

Breast and Prostate Cancer
University of Southern California + Norris Cancer Center & LAC+USC

BRCA Main Home Nutritional Intervention-Random Study (NCT03570125). University Hospital, “Policlinico Paolo Giaccone” of Palermo, Italy.

Breast Cancer
University Hospital of Palermo

Fasting-Mimicking Diet In Patients Receiving Chemo-Immunotherapy For Treatment Of Metastatic Non-Small Cell Lung Cancer. (NCT03700437) Eskenazi Hospital, Indiana University Melvin and Bren Simon Cancer Center.

Lung Cancer
Indiana University
COMPLETED

Safety, Feasibility And Metabolic Effects Of The Fasting Mimicking Diet (FMD) In Cancer Patients (NCT03340935) Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.

Various Cancers
IRCCS National Tumor Institute, Milan

Dietary Restriction As An Adjunct Neoadjuvant Chemotherapy For Her2 Negative Breast Cancer (DIRECT) (NCT02126449). Quality of life and illness perceptions in patients with breast cancer using a fasting mimicking diet as an adjunct to neoadjuvant chemotherapy in the phase 2 DIRECT trial (NCT02126449). Leiden University Medical Center, Leiden, The Netherlands.
PUBLISHED de Groot et al. Nature Communications (2020)
PUBLISHED Lugtenberg et al. Breast Cancer Res Treat. (2021)

Breast Cancer
Leiden University Medical Centre

Phase II Study Of A Diet That Simulates Fasting In Patients Undergoing Cancer Treatment. (NCT03595540) University of Genova, Italy.
PUBLISHED Caffa, I. et al. Nature. (2020)
PUBLISHED Valdemarin, F. et al. Cancers. (2021)

Solid and Hematologic Malignancies
University of Genova, Italy

Fasting And Nutritional Therapy In Patients With Advanced Metastatic Prostate Cancer (NCT02710721). Charité University, Berlin, Germany.

Prostate Cancer
Charité University, Berlin

Fasting And Cancer Treatment In Humans: A Case Series Report. University of Southern California, Los Angeles.
PUBLISHED Safdie, Fernando M et al. Aging. (2009)

Various Cancers
University of Southern California

The Effects Of Short-Term Fasting On Tolerance To (Neo) Adjuvant Chemotherapy In Her2-Negative Breast Cancer Patients: A Randomized Pilot Study (NCT01304251). Leiden, The Netherlands

Breast Cancer
Leiden University Medical Centre

Short-Term Fasting Prior To Platinum-Based Chemotherapy: Feasibility and Impact on Toxicity (NCT00936364). University Of Southern California, Los Angeles, in collaboration with Norris Cancer Center.
PUBLISHED Dorff, T. B. et al. BMC Cancer (2016)

Solid Tumor Malignancies
University of Southern California + Norris Cancer Center

Short-Term Fasting During Chemotherapy In Patients With Gynecological Cancer- A Randomized Controlled Cross-Over Trial (Fit) (NCT01954836). Charité University, Berlin, Germany.

Gynecological Cancer
Charité University, Berlin

PCI.GC.002: A Prospective Pilot Cohort Study of patients with a known diagnosis of Cancer, to document its Metabolic Effects, including Cancer Fatigue, and Metabolic Syndrome, as well as Lifestyle Changes in the clinic. Prostate Cancer Institute, Galway Clinic and National University of Galway (NUIG), Ireland.

Prostate Cancer
National University of Galway, Ireland
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Autoimmune Clinical Trials
Disease State
Leading University
ONGOING

The Influence of a Fasting Mimicking Diet on Ulcerative Colitis. (NCT03615690) Division of Gastroenterology & Hepatology Stanford University School of Medicine.

Ulcerative Colitis
Stanford University

A Fasting Mimicking Diet on Ulcerative Colitis Patients Undergoing Tofacitinib Induction. (NCT04505410) University of Miami. Collaboration with Pfizer.

Ulcerative Colitis
University of Miami + Pfizer
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Neurodegenerative & Depression Clinical Trials
Disease State
Leading University
ONGOING

A Run-In Study On The Safety And Tolerability Of A Fasting Mimicking Diet In Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta 1a (Fast-MS Run-In Study). Clinica Neurologica, Ospedale Policlinico S. Martino, Genova, Italy.

Multiple Sclerosis
Neurology Clinic, S. Martino Polyclinic Hospital, Italy

Randomized Phase I / II Study Of A Hypoproteic Diet In Patients With Cognitive Impairment. Genova, Italy, University of Genova.

Cognitive Impairment
University of Genova, Italy
COMPLETED

A Randomised Controlled Pilot Study to Compare the Effects of Prolonged Fasting and Ketogenic Low Glycemic Load Treatment on Health Related Quality of Life in Relapsing-remitting Multiple Sclerosis (IGEL). Charité University, Berlin, Germany. (NCT01538355).
PUBLISHED Choi, Y., et al. Cell Reports. (2016)

Multiple Sclerosis
Charité University, Berlin

A Randomized-Controlled Pilot Study To Evaluate The Efficacy Of A Fasting Mimicking Diet Added To Functional Therapy For Depression (NCT04050475) Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo.
PUBLISHED Maniaci G. et al. J Clin Psychol. (2020)

Depression
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Italy
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Miscellaneous Clinical Trials
Disease State
Leading University
ONGOING

Randomized Phase I/II Study on FMD for the Stimulation of the Anti-Influenza Immunity in the Pre-Fragile Elderly Subject. Policlinico San Martino Genova.

Flu Vaccine Response
S. Martino Polyclinic Hospital, Italy

Pilot Study on the Effects of Fasting Mimicking Diet (FMD) in Women with polycystic Ovary Syndrome (PCOS). University of Salento, Lecce, Italy

Polycystic Ovarian Syndrome
University of Salento, Lecce, Italy
COMPLETED

Effects Of Fasting-Mimicking Diet On Central And Peripheral Components Of Fatigue, Muscular Resistance. University of Verona, Italy.

Muscular Resistance
University of Verona, Italy
Overall Clinical Trial Summary
Ongoing
Completed
Cardiometabolic
2
6
Oncology
5
9
Autoimmune
2
0
Neurodegenerative + Depression
2
2
Miscellaneous
2
1
Total
13
18 (14 Published)