Our overarching hypothesis is that plant-based diets will induce beneficial modifications of the gut microbiota favoring short fatty acid (SCFA)-producing commensals and a more advantageous CD8/Th17 ratio in sMM patients, thus preventing evolution to MM. Goal of this national, prospective, multicenter study is to demonstrate that plant-based diets substantially modify the gut microbiome inducing increased production of SCFAs in patients affected by sMM. The study will involve up to 62 patients affected by sMM. 56 Enrolled and eligible patients will be encouraged to consume a balanced diet rich in fiber for the entire duration of the trial (i.e., 12 weeks). Patients will choose among a list of different diet plans or individual food according to the personal tastes and preference. Free outpatient medical visit will be performed at enrollment and at week 12, and nutritional counseling will be given at the time of enrollment, one month later and on demand. As in line with routine diagnosis and follow-up of for patients affected by sMM, the investigators will collect bone marrow aspirates and peripheral blood at the time of screening, for plasma, serum, and peripheral blood mononuclear cells (PBMCs), while stool samples will be collected immediately before diet initiation. The investigators will also collect stool samples 4 and 12 weeks after diet initiation, and peripheral blood at 12 weeks after study initiation (as per routine clinical follow-up of this patient population). Dietary measurements will be conducted along the entire duration of the nutritional regimen by questionnaires. Biological paired comparison will be conducted between data obtained from samples collected at time 0 and samples collected 4 and 12 weeks later.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
62
Enrolled and eligible patients will be encouraged to consume a balanced diet rich in fiber for the entire duration of the trial (i.e., 12 weeks). Patients will also be encouraged to prolong plant-based diets beyond week 12. Free outpatient medical visit will be performed at enrollment and at week 12, and nutritional counseling will be given at the time of enrollment, one month later and on demand. Dietary measurements will be conducted along the entire duration of the nutritional regimen by questionnaires. In particular, the patient will write for each day of the trial the number associated to the chosen diet plan or food.
IRCCS Ospedale San Raffaele
Milan, Milano, Italy
RECRUITINGOspedale Giovanni XXIII Policlinico di Bari
Bari, Italy
NOT_YET_RECRUITINGFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
NOT_YET_RECRUITINGFondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
NOT_YET_RECRUITINGAzienda Ospedaliero Universitaria di Parma
Parma, Italy
NOT_YET_RECRUITINGTo evaluate the effects of high-fiber diets on mean SCFA concentration in stool samples.
Concentration of at least one among the three main SCFAs (acetate, butyrate and propionate) in stool samples from participants. Stool samples will be collected at Baseline visit (day 0) and 4 and 12 weeks later. SCFAs will be measured by targeted nuclear magnetic resonance.
Time frame: Stool sampling at day 0, 28 and 84 since high-fiber diet starts.
To evaluate adherence to the diet regimen.
Frequency of participants adhering to the high-fiber diet (≥ 40g/die) at week 4 and 12 weeks since the start.
Time frame: Daily dietary measurement by questionnaires and food diary and dietary interview (30 minutes, either in-presence or virtually) at day 0, 28 and 84 since high-fiber diet starts.
To evaluate the effects of high-fiber diets on gut microbiome composition.
Composition of the gut microbiota. Stool samples will be collected at Baseline visit (day 0) and 4 and 12 weeks later. Composition of the gut microbiota will be obtained by 16S ribosomal RNA sequencing of paired stool samples.
Time frame: Stool sampling at day 0, 28 and 84 since high-fiber diet starts.
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