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Clinical Trials in Spain / NCT04824053
Recruiting Not applicable

Effects of UNICLA-A2 Dairy Products on Patients at High-risk of Colorectal Cancer Development

NCT04824053 · tracked via the Priya Life Science Spain tracker
Sponsor
Instituto de Investigación Sanitaria Aragón
Phase
Not applicable
Started
2022-02-28
Last updated
2026-05-12

Condition(s) studied

Colorectal Polyp

Investigational drug(s) / intervention(s)

Milk 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 seleniumConventional milkYogurt 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 seleniumConventional yogurtFresh 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 seleniumConventional fresh cheese

Milk 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

Conventional milk: 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

Yogurt 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

Conventional 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

Fresh 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

Conventional 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

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. 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) 2. Regular consumer of milk and dairy products. 3. Informed consent form signed. Exclusion Criteria: 1. History of allergic reaction attributed to compounds of similar chemical composition to the study agents. 2. Incomplete colonoscopy or with poor quality criteria, Boston \<6. 3. Concomitant acetylsalicylic acid (ASA), NSAIDs, misoprostol, corticosteroids or statins needed on a regular or predictable basis during the time of the study. 4. Previous gastrointestinal surgery (colon or small intestine or gastric) that affects the absorption of nutrients. 5. History of familial adenomatous polyposis.

Primary outcome measure(s)

  • Change from baseline levels in pro-inflammatory circulating markers C-reactive protein (CRP), interleukin (IL)-6, macrophage inhibitory cytokine 1 (MIC-1) and tumour necrosis factor alpha (TNFα), as well as in fecal calprotectin. — At baseline, at 3 months and through study completion, an average of 1 year after the colonoscopy that motivated the patient´s inclusion
    The C-reactive protein and calprotectin are measured by conventional methods in the University Clinic Hospital Lozano Blesa and the circulating biomarkers IL-6, MIC-1 and TNFα by enzyme-linked immunosorbent assay

Trial sites (1)

FacilityCityRegionStatus
Angel Lanas Arbeloa Zaragoza Zaragoza Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04824053 on ClinicalTrials.gov ↗ ← All trials in Spain