Modified MAC Diet and Gut Microbiota in CRC Patients

NCT05039060 | Unknown

• 1 other identifier: modifiedMAC001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Colorectal Cancer; Gut Microbiota; Diet Intervention

Keywords

Colorectal Cancer; Gut Microbiota; microbiota accessible carbohydrates

Outcome Measures

Primary Outcomes (1)

• The change of gut microbiota diversity

  a-diversity for interpersonal change and b-diversity for groups using 16s rRNA sequencing

  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

  Up to 6 week (during study period)

• The change of quality of life

  Survey for baseline, after the first 3-week diet, and then after second 3-week diet

• The change of quality of life

  Survey for baseline, after the first 3-week diet, and then after second 3-week diet

• The change of gut microbiota metabolite

  Stool sample collection for baseline, after the first 3-week diet, and then after second 3-week diet

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Group 1: Modified MAC diet (first 3-weeks) followed by conventional diet (second 3-weeks)

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)

Dietary Supplement: Modified MAC diet (3-weeks)

Interventions

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

Group 1; Group 2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Soohyeon Lee

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soohyeon Lee, M.D., Ph.D.

CONTACT

02-920-5690; soohyeon_lee@korea.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: September 9, 2021
• Study Start: September 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: February 28, 2023
• Last Updated: September 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)