RecruitingNot ApplicableNCT04824053

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

Sponsor

Instituto de Investigación Sanitaria Aragón

Enrollment

34 participants

Start Date

Feb 28, 2022

Study Type

INTERVENTIONAL

Conditions

Colorectal Polyp

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a dairy product containing a special type of fatty acid (called CLA, conjugated linoleic acid) can reduce the risk of colorectal cancer returning or growing in people who are already at high risk due to a history of abnormal polyps. The product is consumed daily over a period of time. **You may be eligible if...** - You have been diagnosed with high-risk colon polyps (e.g., serrated polyposis syndrome, multiple adenomas, or large flat lesions) - You are part of a colorectal cancer screening or surveillance program - You have had an early-stage colorectal cancer removed endoscopically without needing surgery **You may NOT be eligible if...** - You have active colorectal cancer requiring surgery or chemotherapy - You have a serious allergy to dairy products - You do not meet the specific polyp history criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTMilk from genetically selected homozygous- β-casein-A2 cows fed with forages and a concentrate enriched on linseed and selenized yeast as sources of PUFAs and selenium

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

DIETARY_SUPPLEMENTConventional milk

DIETARY_SUPPLEMENTYogurt made from milk of genetically selected homozygous- β-casein-A2 cows fed with forages and a concentrate enriched on linseed and selenized yeast as sources of PUFAs and selenium

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

DIETARY_SUPPLEMENTConventional yogurt

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

DIETARY_SUPPLEMENTFresh cheese made from milk of genetically selected homozygous- β-casein-A2 cows fed with forages and a concentrate enriched on linseed and selenized yeast as sources of PUFAs and selenium

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

DIETARY_SUPPLEMENTConventional fresh cheese

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