Effect of a 12-Week Mediterranean Diet on Rectal Submucosa White Adipose Tissue (WAT) Inflammation and Fat Droplet Size in Patients with an Advanced Adenoma or Early colorectal Adenocarcinoma: A Pilot Study The minivan- study

Effect of a 12-Week Mediterranean Diet on Rectal Submucosa White Adipose Tissue (WAT) Inflammation and Fat Droplet Size in Patients with an Advanced Adenoma or Early colorectal Adenocarcinoma: A Pilot Study The minivan- study - Effect of a Mediterranean Diet on Rectal Submucosa WAT Characteristics

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53454

Enrollment

Registered

2022-08-15

Start date

2023-01-16

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bowel cancer

Interventions

The intervention is a 12-week, anti-inflammatory Mediterranean diet (MeD). MeD is characterized by the following:14,15 - a high intake of vegetables, fruit, pulses, grains, and nuts - moderate cons

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Body mass index (BMI) > 25 kg/m2 • Age >18 years • Presence of colorectal polyp > 2 cm • Colorectal polyp eligible for endoscopic resection by means of ESD or EMR

Exclusion criteria

Exclusion criteria: • Not fluent in the Dutch language • Currently follows a vegetarian or plant-based diet • Is undergoing additional treatment (ie, additional surgery or chemoradiotherapy) due to being deemed as having high risk T1 CRC. • Coagulation disorder • Many, large diverticula • Acute colitis

Design outcomes

Primary

Measure	Time frame
- Mean reduction in fat droplet size between the pre- and post-MedD biopsies of the rectal submucosa in participating patients. - Mean reduction in number of crown-like structures the pre- and post-MedD biopsies of the rectal submucosa in participating patients. - Mean change in the M1:M2 macrophage ratio between the pre- and post-MedD biopsies of the rectal submucosa in participating patients.	—

Secondary

Measure	Time frame
- Relationship between baseline rectal submucosa WAT characteristics (number of CLS, M1:M2 macrophage ratio, and fat droplet size) and body composition measures in participating patients. - Relationship between the pre- and post-MedD changes in rectal submucosa WAT characteristics (number of CLS, M1:M2 macrophage ratio, and fat droplet size) and body composition measures in participating patients. - Relationship between baseline rectal submucosa WAT characteristics (number of CLS, M1:M2 macrophage ratio, and fat droplet size) and homeostatic model assessment insulin resistance (HOMA-IR) measures in participating patients. - Relationship between the pre- and post-MedD changes in rectal submucosa WAT characteristics (number of CLS, M1:M2 macrophage ratio, and fat droplet size) and HOMA-IR measures in participating patients. - Relationship between baseline rectal submucosa WAT characteristics (number of CLS, M1:M2 macrophage ratio, and fat droplet size) and liver fat (as a measure of ectopic fat stores) in participating patients. - Relationship between the pre- and post-MedD changes in rectal submucosa WAT characteristics (number of CLS, M1:M2 macrophage ratio, and fat droplet size) and liver fat (as a measure of ectopic fat stores) in participating patients.	—

Measure

Time frame

- Relationship between baseline rectal submucosa WAT characteristics (number of CLS, M1:M2 macrophage ratio, and fat droplet size) and body composition measures in participating patients. - Relationship between the pre- and post-MedD changes in rectal submucosa WAT characteristics (number of CLS, M1:M2 macrophage ratio, and fat droplet size) and body composition measures in participating patients. - Relationship between baseline rectal submucosa WAT characteristics (number of CLS, M1:M2 macrophage ratio, and fat droplet size) and homeostatic model assessment insulin resistance (HOMA-IR) measures in participating patients. - Relationship between the pre- and post-MedD changes in rectal submucosa WAT characteristics (number of CLS, M1:M2 macrophage ratio, and fat droplet size) and HOMA-IR measures in participating patients. - Relationship between baseline rectal submucosa WAT characteristics (number of CLS, M1:M2 macrophage ratio, and fat droplet size) and liver fat (as a measure of ectopic fat stores) in participating patients. - Relationship between the pre- and post-MedD changes in rectal submucosa WAT characteristics (number of CLS, M1:M2 macrophage ratio, and fat droplet size) and liver fat (as a measure of ectopic fat stores) in participating patients.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)