UndefinedMIC-1NCT06794931
Study on the Impact of a Modified Mediterranean Diet, in Patients With Colorectal Cancer Undergoing Active Medical Oncology Treatment
A study testing Nutrition and Biological samples collection in people with Undefined, run by Azienda Socio Sanitaria della Brianza at 1 site in Italy.
Trial summary
The study plans to evaluate the impact of the Modified Mediterranean Diet on the biodiversity of the intestinal microbiota (the set of physiological bacteria present at the intestinal level) in patients suffering from metastatic colorectal cancer undergoing chemotherapy treatment +/- biological agent, comparing the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Undefined
- What is being tested?
- Nutrition and Biological samples collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jul 2024to 23 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group performance status (ECOG): 0 or 1;
- Age ≥ 18;
- Diagnosis of metastatic colorectal cancer, documented histologically and radiologically according to RECIST 1:1 criteria;
- 1st line chemotherapy treatment +/- biological agent (anti-EGFR, anti-VEGF);
- MUST score 0/1;
- Written informed consent.
Who cannot join
- Previous oncological medical therapies;
- Indication for parenteral and/or enteral nutrition;
- MUST score > 2.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
U.O. di Oncologia di Vimercate, ASST-Brianza
Vimercate, MB, 20871
Salvatore Artale, MD, +390396657115, salvatore.artale@asst-brianza.it
About this study
Official title: Randomized Pilot Study on the Impact of a Modified Mediterranean Diet (DMM) on the Intestinal Microbiota and Clinical Outcome in Patients With Colorectal Cancer Undergoing Active Medical Oncology Treatment
The study plans to evaluate the impact of the Modified Mediterranean Diet on the biodiversity of the intestinal microbiota (the set of physiological bacteria present at the intestinal level) in patients suffering from metastatic colorectal cancer undergoing chemotherapy treatment +/- biological agent, comparing the microbiota with that of patients following a Western or standard diet.
Specifically, as well demonstrated in clinical studies, there are populations of bacteria that play a role in protecting the intestinal barrier and whose proliferation could be promoted by the Modified Mediterranean Diet.
The study also intends to evaluate the influence of the microbiome on the clinical progress of the disease in terms of side effects and quality of life.
Read the detailed description
The study will be divided into:
- Screening visit (V0) and Baseline visit (V1): during a control visit, the patient will be asked to participate in the study. After signing the written informed consent for participation in the MIC-1 study, the patient will be screened for his nutritional status. During the visit, a folder will be used to assess nutritional status. Routine blood tests will be carried out, a serum sample will be taken to measure nutritional markers and lifestyle will be assessed. Furthermore, the detection of anthropometric measurements (weight, height, BMI), bioimpedance analysis, estimation of calorie-protein needs and Malnutrition Universal Screening Tool (MUST) nutritional screening is envisaged. Once the study inclusion criteria are met, the patient will return for a visit and randomization into the study arms will take place. Arm A will then be given the modified Mediterranean diet (DMM), while arm B will continue to follow its usual diet. The patient will deliver the fecal sample. Subsequent patient visits will take place every 15 or 21 days depending on the ongoing therapy.
- Visit V2: this visit will be carried out approximately 45 days after the baseline visit. The patient will deliver the stool sample.
- Visit V3: this visit will be carried out approximately 90 days after the baseline visit. During this visit, as per clinical practice, the radiological re-evaluation will be carried out.
- Conditions
- Undefined
- Being tested
- Nutrition, Biological samples collection
- Keywords
- Colorectal Cancer Metastatic, modified Mediterranean diet, Intestinal microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutritionOther
Also called Specific diet
The patient will be instructed to follow the modified Mediterranean diet or his usual diet based on the assigned treatment group.
Biological samples collectionOther
Also called Microbiota analyses
Additional biological samples will also be collected.
| Study group | Role | What they receive |
|---|---|---|
| modified Mediterranean diet (DMM) | Experimental | It consists of a food plan in favor of bacterial biodiversity which focuses above all on foods containing high quality prebiotic fibres, instead reducing the total quantity of fibers compared to the indications provided by the Reference Intake Levels of Nutrients and Energy (LARN) for the Italian population, in consideration of the gastrointestinal side effects of chemotherapy. Receives: Other: Nutrition; Other: Biological samples collection |
| standard western diet (DSO) | Other | The Western Diet or standard diet represents the diet most commonly used by the population in many developed countries; it reflects participants' daily eating habits, ensuring that the control group accurately represents typical eating behavior. Receives: Other: Biological samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the impact of the modified Mediterranean diet (DMM, Arm A) compared to a standard Western diet (DSO, Arm B) on microbiota
Comparison of the Firmicutes/Bacteroidetes ratio after 45 days (V2) of first-line chemotherapy +/- biological agent (anti-Epidermal Growth Factor Receptor (EGFR), anti-VEGF) in patients on a modified Mediterranean diet (DMM) compared to patients on a standard Western diet (DSO)
Measured: V2 (45 days after V1)
Secondary outcomes (5)
Comparison of the percentage of patients with gastrointestinal effects
Comparison of the percentage of patients with gastrointestinal effects in Arm A versus Arm B.
Measured: V2 (45 days after V1)
Comparison of the percentage of patients with severe gastrointestinal effects
Comparison of the percentage of patients with severe gastrointestinal effects (G3/G4) in Arm A versus Arm B.
Measured: V2 (45 days after V1)
Variation of the change in the Firmicutes/Bacteroidetes ratio
Evaluation of the change in the Firmicutes/Bacteroidetes ratio over 3 time points
Measured: Baseline (V1), after 45 day from baseline (V2), after 90 days from baseline (V3)
Variation of the overall composition of the microbiome
Evaluation of the overall composition of the microbiome over 3 time points
Measured: Baseline (V1), after 45 day from baseline (V2), after 90 days from baseline (V3)
Variation of the microbiome and metabolome
Evaluation of the microbiome and metabolome over 3 time points
Measured: Baseline (V1), after 45 day from baseline (V2), after 90 days from baseline (V3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start24 Jul 2024
- Primary completion23 Jul 2028 (estimated)
- Study completion23 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UndefinedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria della Brianza
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milano Bicocca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794931
- Sponsor's protocol ID
- MIC-1
- Acronym
- MIC-1
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Artale S, Filiali F, Beretta E, Arosio F, Cazzaniga F, Tersalvi C, Sofia M, Tagliabue P, Pozzi P, Colombo A, Carbone C, Pietrogiovanna L, Verga M, Nova P, Calori R, Renso R, Rota S, Aglione S, Manfrida I, Facendola G, Trojani A, Dazzani MC, Basciani S, Valsecchi MG, Capitoli G, Cocola C, Consolandi C. The Effects of a Modified Mediterranean Diet on Gut Microbiota and Chemotherapy Side Effects in Patients With Metastatic Colorectal Cancer Undergoing First-Line Chemotherapy With or Without Either Antiepidermal Growth Factor Receptor or Antivascular Endothelial Growth Factor Agent: Protocol for a Randomized Pilot Study in Italy. JMIR Res Protoc. 2025 Nov 14;14:e72950. doi: 10.2196/72950.
PubMed 41236788
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pilot Study on the Impact of a Modified Mediterranean Diet (DMM) on the Intestinal Microbiota and Clinical Outcome in Patients With Colorectal Cancer Undergoing Active Medical Oncology Treatment
- ClinicalTrials.gov ID
- NCT06794931
- Acronym / sponsor ID
- MIC-1 / MIC-1
- Conditions
- Undefined
- Keywords
- Colorectal Cancer Metastatic, modified Mediterranean diet, Intestinal microbiota
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria della BrianzaUniversity, hospital or other
- Collaborators
- University of Milano Bicocca
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 23 Jul 2028 (estimated)
- Study completion
- 23 Jul 2028 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study plans to evaluate the impact of the Modified Mediterranean Diet on the biodiversity of the intestinal microbiota (the set of physiological bacteria present at the intestinal level) in patients suffering from metastatic colorectal cancer undergoing chemotherapy treatment +/- biological agent, comparing the microbiota with that of patients following a Western or standard diet.
Specifically, as well demonstrated in clinical studies, there are populations of bacteria that play a role in protecting the intestinal barrier and whose proliferation could be promoted by the Modified Mediterranean Diet.
The study also intends to evaluate the influence of the microbiome on the clinical progress of the disease in terms of side effects and quality of life.
Detailed description
The study will be divided into:
- Screening visit (V0) and Baseline visit (V1): during a control visit, the patient will be asked to participate in the study. After signing the written informed consent for participation in the MIC-1 study, the patient will be screened for his nutritional status. During the visit, a folder will be used to assess nutritional status. Routine blood tests will be carried out, a serum sample will be taken to measure nutritional markers and lifestyle will be assessed. Furthermore, the detection of anthropometric measurements (weight, height, BMI), bioimpedance analysis, estimation of calorie-protein needs and Malnutrition Universal Screening Tool (MUST) nutritional screening is envisaged. Once the study inclusion criteria are met, the patient will return for a visit and randomization into the study arms will take place. Arm A will then be given the modified Mediterranean diet (DMM), while arm B will continue to follow its usual diet. The patient will deliver the fecal sample. Subsequent patient visits will take place every 15 or 21 days depending on the ongoing therapy.
- Visit V2: this visit will be carried out approximately 45 days after the baseline visit. The patient will deliver the stool sample.
- Visit V3: this visit will be carried out approximately 90 days after the baseline visit. During this visit, as per clinical practice, the radiological re-evaluation will be carried out.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified Mediterranean diet (DMM) | Experimental | Other: Nutrition, Other: Biological samples collectionIt consists of a food plan in favor of bacterial biodiversity which focuses above all on foods containing high quality prebiotic fibres, instead reducing the total quantity of fibers compared to the indications provided by the Reference Intake Levels of Nutrients and Energy (LARN) for the Italian population, in consideration of the gastrointestinal side effects of chemotherapy. |
| standard western diet (DSO) | Other | Other: Biological samples collectionThe Western Diet or standard diet represents the diet most commonly used by the population in many developed countries; it reflects participants' daily eating habits, ensuring that the control group accurately represents typical eating behavior. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eastern Cooperative Oncology Group performance status (ECOG): 0 or 1;
- Age ≥ 18;
- Diagnosis of metastatic colorectal cancer, documented histologically and radiologically according to RECIST 1:1 criteria;
- 1st line chemotherapy treatment +/- biological agent (anti-EGFR, anti-VEGF);
- MUST score 0/1;
Key exclusion criteria (3 listed)
- Previous oncological medical therapies;
- Indication for parenteral and/or enteral nutrition;
- MUST score > 2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NutritionAlso: Specific dietThe patient will be instructed to follow the modified Mediterranean diet or his usual diet based on the assigned treatment group. | Other | modified Mediterranean diet (DMM) |
| Biological samples collectionAlso: Microbiota analysesAdditional biological samples will also be collected. | Other | modified Mediterranean diet (DMM), standard western diet (DSO) |
Primary outcome
Evaluate the impact of the modified Mediterranean diet (DMM, Arm A) compared to a standard Western diet (DSO, Arm B) on microbiota
Time frame: V2 (45 days after V1)
Comparison of the Firmicutes/Bacteroidetes ratio after 45 days (V2) of first-line chemotherapy +/- biological agent (anti-Epidermal Growth Factor Receptor (EGFR), anti-VEGF) in patients on a modified Mediterranean diet (DMM) compared to patients on a standard Western diet (DSO)
5 secondary outcomes
Comparison of the percentage of patients with gastrointestinal effects
Time frame: V2 (45 days after V1)
Comparison of the percentage of patients with severe gastrointestinal effects
Time frame: V2 (45 days after V1)
Variation of the change in the Firmicutes/Bacteroidetes ratio
Time frame: Baseline (V1), after 45 day from baseline (V2), after 90 days from baseline (V3)
Variation of the overall composition of the microbiome
Time frame: Baseline (V1), after 45 day from baseline (V2), after 90 days from baseline (V3)
Variation of the microbiome and metabolome
Time frame: Baseline (V1), after 45 day from baseline (V2), after 90 days from baseline (V3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Derived from this study: PubMed 41236788Artale S, Filiali F, Beretta E, Arosio F, Cazzaniga F, Tersalvi C, Sofia M, Tagliabue P, Pozzi P, Colombo A, Carbone C, Pietrogiovanna L, Verga M, Nova P, Calori R, Renso R, Rota S, Aglione S, Manfrida I, Facendola G, Trojani A, Dazzani MC, Basciani S, Valsecchi MG, Capitoli G, Cocola C, Consolandi C. The Effects of a Modified Mediterranean Diet on Gut Microbiota and Chemotherapy Side Effects in Patients With Metastatic Colorectal Cancer Undergoing First-Line Chemotherapy With or Without Either Antiepidermal Growth Factor Receptor or Antivascular Endothelial Growth Factor Agent: Protocol for a Randomized Pilot Study in Italy. JMIR Res Protoc. 2025 Nov 14;14:e72950. doi: 10.2196/72950.
- Individual participant dataSharing planned: Undecided
Related trials for Undefined
RecruitingPhase 2
A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant
Graft-Versus-Host Disease, GVHD
RecruitingObservational study
Molecular and Genetic Studies of Congenital Myopathies
Central Core Disease, Centronuclear Myopathy
RecruitingObservational study
Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.
Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and Biological samples collection in people with Undefined, run by Azienda Socio Sanitaria della Brianza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salvatore Artale, MD (+390396657115, salvatore.artale@asst-brianza.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the impact of the modified Mediterranean diet (DMM, Arm A) compared to a standard Western diet (DSO, Arm B) on microbiota (time frame: V2 (45 days after V1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06794931, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.