Effects of UNICLA-A2 Dairy Products on Patients At High-risk of Colorectal Cancer Development
Comparative Analysis of the Effects of UNICLA-A2 Against Conventional Dairy Products Administered Daily in Patients At High-risk Colorectal Cancer Development Who Have Undergone Polypectomy
Instituto de Investigación Sanitaria Aragón
34 participants
Feb 28, 2022
INTERVENTIONAL
Conditions
Summary
Dietary intervention with UNICLA-A2 milk products containing beta casein A2 protein, and higher levels of omega-3 fatty acids and selenium may contribute to maintain the intestinal integrity, reduce inflammatory processes, normalize the immune system, protect against oxidative damage and equilibrate the gut microbiota in high-risk colorectal cancer patients who have undergone polypectomy
Eligibility
Inclusion Criteria11
- Participants diagnosed with high-risk polyps in the colorectal cancer screening programme or in the relative's colon cancer prevention program or patients who are in follow-up due to prior detection of polyps with any of the following characteristics:
- At least 10 adenomas
- At least 5 proximal serrated polyps (PSP)
- At least 2 serrated polyps with diameters ≥10 mm
- Serrated Polyposis Syndrome (SPS)
- Early invasive CRC (stage pT1) endoscopically resected (surgery not required)
- A sessile or flat lesion ≥ 20 mm with fragmented resection
- Patients with previous resection of polyps in which the resection margin was not assessable and are considered susceptible to repeat colonoscopy
- Patients with intramucosal carcinoma in situ or invasion of the lamina propria (pTis)
- Regular consumer of milk and dairy products.
- Informed consent form signed.
Exclusion Criteria5
- History of allergic reaction attributed to compounds of similar chemical composition to the study agents.
- Incomplete colonoscopy or with poor quality criteria, Boston \<6.
- Concomitant acetylsalicylic acid (ASA), NSAIDs, misoprostol, corticosteroids or statins needed on a regular or predictable basis during the time of the study.
- Previous gastrointestinal surgery (colon or small intestine or gastric) that affects the absorption of nutrients.
- History of familial adenomatous polyposis.
Interventions
The daily intake should reflect habitual consumption habits in "real life" conditions, without forcing or inducing greater consumption. Therefore, patients will be recommended a daily intake of 250 mL of milk. The intervention duration will be 3 months
The daily intake should reflect habitual consumption habits in "real life" conditions, without forcing or inducing greater consumption. Therefore, patients will be recommended a daily intake of 250 mL of milk. The intervention duration will be 3 months
The daily intake should reflect habitual consumption habits in "real life" conditions, without forcing or inducing greater consumption. Therefore, patients will be recommended a daily intake of one yogurt. The intervention duration will be 3 months
The daily intake should reflect habitual consumption habits in "real life" conditions, without forcing or inducing greater consumption. Therefore, patients will be recommended a daily intake of one yogurt. The intervention duration will be 3 months
The daily intake should reflect habitual consumption habits in "real life" conditions, without forcing or inducing greater consumption. Therefore, patients will be recommended a daily intake of 50 g of fresh cheese. The intervention duration will be 3 months
The daily intake should reflect habitual consumption habits in "real life" conditions, without forcing or inducing greater consumption. Therefore, patients will be recommended a daily intake of 50 g of fresh cheese. The intervention duration will be 3 months
Locations(1)
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NCT04824053