Colorectal CancerNCT05039060
Modified MAC Diet and Gut Microbiota in CRC Patients
A study testing Modified MAC diet (3-weeks) in people with Colorectal Cancer and Gut Microbiota, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
To explore the changes in the composition and diversity of intestinal microbiota during 3-weeks of modified MAC diet and conventional diet in stage I or low-risk stage II colorectal cancer (CRC) patients after surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Colorectal Cancer, Gut Microbiota, Diet Intervention
- What is being tested?
- Modified MAC diet (3-weeks)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2021to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed colorectal adenocarcinoma patients after curative surgery without post-operative chemotherapy (stage I and low-risk stage II)
- Male of female participants over the age of 19
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol
- Adequate hematologic and end-organ function
Who cannot join
- Patients with temporary/permanent stoma after surgery
- Diagnosed with locally advanced stage (more than high-risk stage II) colorectal cancer which require postoperative chemotherapy after surgery
- Diagnosed with metastatic stage IV colorectal cancer after surgery
- Uncontrolled diabetes (glycated hemoglobin A1c (HbA1c) > 8.0 g/dl)
- Active infection requiring antibiotics, antifungal or antiviral agents or received a course of antibiotics within 4 weeks prior to study treatments
- Known history of food allergy
- Known history of uncontrolled intercurrent illness including but not limited to: Infection/inflammation; severe liver dysfunction; bilateral interstitial lung disease; uncontrolled kidney disease; clinically significant (active) cardiovascular and pulmonary disease; hemorrhagic disease; inflammatory bowel disease, intestinal obstruction; Inability to swallow food; social and psychological problems etc.)
- Other medical and psychiatric conditions that would prohibit the understanding or rendering of informed consent which affect study compliance
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea University Anam Hospital
Seoul, 02841
Soohyeon Lee, M.D., Ph.D., soohyeon_lee@korea.ac.kr
About this study
Official title: A Modified Microbiota-Accessible Carbohydrates (MAC) Diet and Change of Gut Microbiota in Patients With Colorectal Cancer After Surgery: A Prospective, Open-label, Cross-over, Single Center Study
To explore the changes in the composition and diversity of intestinal microbiota during 3-weeks of modified MAC diet and conventional diet in stage I or low-risk stage II colorectal cancer (CRC) patients after surgery. Additionally, the investigator analyze the association of gut microbiota and stool formation pattern or quality of life according to dietary pattern. Therefore, the investigator identify the beneficial or harmful microbiota composition and diversity adapting modified MAC diet that related to cancer recurrence, which provide supporting evidence for future prospective trial.
Read the detailed description
Colorectal cancer is the third most common cancer worldwide and a life-threatening disease that kills more than 500,000 people every year. It is known that, environmental factors such as diet and lifestyle play an important role in the development of colorectal cancer due to large differences in the incidence rate by region in addition to the genetic background associated with colorectal cancer. The physical activity, whole grains, dietary fiber, dairy products, and calcium supplement intake are factors that inhibit colorectal cancer, but red meat, processed meat, alcohol, and obesity act as risk factors inducing colorectal cancer. Therefore, it can be said that efforts to prevent cancer are important compared to other cancers.
A growing interest in the interaction of the gut microbiome with its host and its important role in health and disease is revealing that the interaction of the gut microbiome with humans plays an important role in the development of degenerative diseases, cancers and inflammatory diseases. According to recent studies, the risk of colorectal cancer is increased by the presence of specific gut microbiota, dysbiosis, and the interaction between diet and gut microbes. In other words, changes in diet affect the formation of the intestinal microbiota, and conversely, microorganisms mediate the generation of dietary factors that cause colorectal cancer.
In addition, microorganisms such as Fusobacterium nucleatum regulate autophagy and play a role in making it resistant to chemotherapy after colon cancer surgery, or whole grains in colorectal cancer patients with Fusobacterium nucleatum in tumor tissue. However, a cohort study has also reported that consuming a diet rich in dietary fiber helps to lower the incidence of colorectal cancer.
Diet and nutrients play a decisive role in the composition of the intestinal microflora involved in the regulation of inflammation and immune responses.
Microbiota-Accessible Carbohydrates (MAC) refer to carbohydrates that the human intestine cannot digest, but that can be digested by intestinal microbes. It is not decomposed and not absorbed in the stomach or small intestine, and then broken down in the large intestine and then digested and metabolized by the intestinal microflora. During that process, short chain fatty acid (SCFA) is produced, which is known to increase beneficial intestinal bacteria and decrease inflammation around intestinal cells.
The composition of intestinal microbes changes due to intestinal preparation before colon cancer surgery, use of prophylactic antibiotics, and tissue changes in the intestine anastomosis, which may lead to enhanced toxicity, proliferation of pathogens, and reduction of beneficial intestinal bacteria. In addition, the presence of certain microorganisms may lead to complications such as anastomotic leakage or infection at the surgical site.
Thanks to the development of various genomic research techniques, there is a difference in the composition of intestinal microbes between colorectal cancer patients and healthy people, and the microbiome affects the development of adenoma or cancer as the number of beneficial bacteria decreases, the harmful bacteria changes in terms of age.
In this study, a modified MAC diet designed to adapt to a high-fiber diet after surgery and a patient-made diet for stage 1-2 colorectal cancer patients who do not receive chemotherapy after colon cancer surgery using the genomic analysis technique The purpose of this study is to explore the effect of diet on the composition of the intestinal microflora, and to analyze whether the different diet affects the pattern of defecation after colorectal cancer surgery, and the effect of these changes on the quality of life after colorectal cancer surgery.
- Conditions
- Colorectal Cancer, Gut Microbiota, Diet Intervention
- Being tested
- Modified MAC diet (3-weeks)
- Keywords
- Colorectal Cancer, Gut Microbiota, microbiota accessible carbohydrates
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified MAC diet (3-weeks)Dietary supplement
- Modified MAC diet to adapt reduced energy intake and increased dietary fiber consumption with appropriate nutrients component
- Dr.Kitchen Inc. directly provide home delivery service for the modified MAC diet including multigrain rice, meal kit, and snacks per day in a regular basis
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Group 1: Modified MAC diet (first 3-weeks) followed by conventional diet (second 3-weeks) Receives: Dietary Supplement: Modified MAC diet (3-weeks) |
| Group 2 | Placebo comparator | Group 2: Conventional diet (first 3-weeks) followed by modified MAC diet (second 3-weeks) Receives: Dietary Supplement: Modified MAC diet (3-weeks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of gut microbiota diversity
a-diversity for interpersonal change and b-diversity for groups using 16s rRNA sequencing
Measured: Stool sample collection for baseline, after the first 3-week diet, and then after second 3-week diet
Secondary outcomes (4)
The change of stool formation pattern
Daily check for stool pattern using Bristol Stool Score
Measured: Up to 6 week (during study period)
The change of quality of life
3 times check for quality of life using EORTC QLQ-C30 plus QLQ-CR29 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30 items for Common function and symptom plus 29 items specific for colorectal cancer, It is converted into a score range from 0-100, and the overall quality of life score is high, The higher the functional domain score and the lower the symptom domain score, the better the quality of life.)
Measured: Survey for baseline, after the first 3-week diet, and then after second 3-week diet
The change of quality of life
3 times check for quality of life using EORTC QLQ-C30 plus QLQ-CR29
Measured: Survey for baseline, after the first 3-week diet, and then after second 3-week diet
The change of gut microbiota metabolite
Analysis for gut microbiota producing short chain fatty acid
Measured: Stool sample collection for baseline, after the first 3-week diet, and then after second 3-week diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start1 Sep 2021 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Approximately 40 participants will be randomly assigned to following group (group 1 or group 2). The subjects will be consumed the modified MAC or conventional diet for first 3-weeks period then cross-over to second 3-weeks period.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soohyeon Lee, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039060
- Sponsor's protocol ID
- modifiedMAC001
- Status last verified
- Aug 2021
- First submitted
- 10 Aug 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modified Microbiota-Accessible Carbohydrates (MAC) Diet and Change of Gut Microbiota in Patients With Colorectal Cancer After Surgery: A Prospective, Open-label, Cross-over, Single Center Study
- ClinicalTrials.gov ID
- NCT05039060
- Acronym / sponsor ID
- modifiedMAC001
- Conditions
- Colorectal Cancer, Gut Microbiota, Diet Intervention
- Keywords
- Colorectal Cancer, Gut Microbiota, microbiota accessible carbohydrates
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 9 Sep 2021 (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.
To explore the changes in the composition and diversity of intestinal microbiota during 3-weeks of modified MAC diet and conventional diet in stage I or low-risk stage II colorectal cancer (CRC) patients after surgery. Additionally, the investigator analyze the association of gut microbiota and stool formation pattern or quality of life according to dietary pattern. Therefore, the investigator identify the beneficial or harmful microbiota composition and diversity adapting modified MAC diet that related to cancer recurrence, which provide supporting evidence for future prospective trial.
Detailed description
Colorectal cancer is the third most common cancer worldwide and a life-threatening disease that kills more than 500,000 people every year. It is known that, environmental factors such as diet and lifestyle play an important role in the development of colorectal cancer due to large differences in the incidence rate by region in addition to the genetic background associated with colorectal cancer. The physical activity, whole grains, dietary fiber, dairy products, and calcium supplement intake are factors that inhibit colorectal cancer, but red meat, processed meat, alcohol, and obesity act as risk factors inducing colorectal cancer. Therefore, it can be said that efforts to prevent cancer are important compared to other cancers.
A growing interest in the interaction of the gut microbiome with its host and its important role in health and disease is revealing that the interaction of the gut microbiome with humans plays an important role in the development of degenerative diseases, cancers and inflammatory diseases. According to recent studies, the risk of colorectal cancer is increased by the presence of specific gut microbiota, dysbiosis, and the interaction between diet and gut microbes. In other words, changes in diet affect the formation of the intestinal microbiota, and conversely, microorganisms mediate the generation of dietary factors that cause colorectal cancer.
In addition, microorganisms such as Fusobacterium nucleatum regulate autophagy and play a role in making it resistant to chemotherapy after colon cancer surgery, or whole grains in colorectal cancer patients with Fusobacterium nucleatum in tumor tissue. However, a cohort study has also reported that consuming a diet rich in dietary fiber helps to lower the incidence of colorectal cancer.
Diet and nutrients play a decisive role in the composition of the intestinal microflora involved in the regulation of inflammation and immune responses.
Microbiota-Accessible Carbohydrates (MAC) refer to carbohydrates that the human intestine cannot digest, but that can be digested by intestinal microbes. It is not decomposed and not absorbed in the stomach or small intestine, and then broken down in the large intestine and then digested and metabolized by the intestinal microflora. During that process, short chain fatty acid (SCFA) is produced, which is known to increase beneficial intestinal bacteria and decrease inflammation around intestinal cells.
The composition of intestinal microbes changes due to intestinal preparation before colon cancer surgery, use of prophylactic antibiotics, and tissue changes in the intestine anastomosis, which may lead to enhanced toxicity, proliferation of pathogens, and reduction of beneficial intestinal bacteria. In addition, the presence of certain microorganisms may lead to complications such as anastomotic leakage or infection at the surgical site.
Thanks to the development of various genomic research techniques, there is a difference in the composition of intestinal microbes between colorectal cancer patients and healthy people, and the microbiome affects the development of adenoma or cancer as the number of beneficial bacteria decreases, the harmful bacteria changes in terms of age.
In this study, a modified MAC diet designed to adapt to a high-fiber diet after surgery and a patient-made diet for stage 1-2 colorectal cancer patients who do not receive chemotherapy after colon cancer surgery using the genomic analysis technique The purpose of this study is to explore the effect of diet on the composition of the intestinal microflora, and to analyze whether the different diet affects the pattern of defecation after colorectal cancer surgery, and the effect of these changes on the quality of life after colorectal cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Approximately 40 participants will be randomly assigned to following group (group 1 or group 2). The subjects will be consumed the modified MAC or conventional diet for first 3-weeks period then cross-over to second 3-weeks period.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Dietary Supplement: Modified MAC diet (3-weeks)Group 1: Modified MAC diet (first 3-weeks) followed by conventional diet (second 3-weeks) |
| Group 2 | Placebo comparator | Dietary Supplement: Modified MAC diet (3-weeks)Group 2: Conventional diet (first 3-weeks) followed by modified MAC diet (second 3-weeks) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed colorectal adenocarcinoma patients after curative surgery without post-operative chemotherapy (stage I and low-risk stage II)
- Male of female participants over the age of 19
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol
- Adequate hematologic and end-organ function
Key exclusion criteria (8 listed)
- Patients with temporary/permanent stoma after surgery
- Diagnosed with locally advanced stage (more than high-risk stage II) colorectal cancer which require postoperative chemotherapy after surgery
- Diagnosed with metastatic stage IV colorectal cancer after surgery
- Uncontrolled diabetes (glycated hemoglobin A1c (HbA1c) > 8.0 g/dl)
- Active infection requiring antibiotics, antifungal or antiviral agents or received a course of antibiotics within 4 weeks prior to study treatments
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 |
|---|---|---|
| Modified MAC diet (3-weeks)* Modified MAC diet to adapt reduced energy intake and increased dietary fiber consumption with appropriate nutrients component * Dr.Kitchen Inc. directly provide home delivery service for the modified MAC diet including multigrain rice, meal kit, and snacks per day in a regular basis | Dietary supplement | Group 1, Group 2 |
Primary outcome
The change of gut microbiota diversity
Time frame: Stool sample collection for baseline, after the first 3-week diet, and then after second 3-week diet
a-diversity for interpersonal change and b-diversity for groups using 16s rRNA sequencing
4 secondary outcomes
The change of stool formation pattern
Time frame: Up to 6 week (during study period)
The change of quality of life
Time frame: Survey for baseline, after the first 3-week diet, and then after second 3-week diet
The change of quality of life
Time frame: Survey for baseline, after the first 3-week diet, and then after second 3-week diet
The change of gut microbiota metabolite
Time frame: Stool sample collection for baseline, after the first 3-week diet, and then after second 3-week diet
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Soohyeon Lee principal investigator
Korea University Anam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified MAC diet (3-weeks) in people with Colorectal Cancer and Gut Microbiota, run by Korea University Anam Hospital at 1 site in South Korea.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 Sep 2021. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soohyeon Lee, M.D., Ph.D. (02-920-5690, soohyeon_lee@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of gut microbiota diversity (time frame: Stool sample collection for baseline, after the first 3-week diet, and then after second 3-week diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2021.