Clinical trial · Interventional
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
NCT04824053CI-TRIAL-00111162recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Polyp | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional fresh cheese | Dietary Supplement | — | UNRESOLVED |
| Conventional milk | Dietary Supplement | — | UNRESOLVED |
| Conventional yogurt | Dietary Supplement | — | UNRESOLVED |
| 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 | Dietary Supplement | — | UNRESOLVED |
| 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 | Dietary Supplement | — | UNRESOLVED |
| 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 |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- UNICLA-A2 milk and its subproducts
- description
- Participants (n=17) ingest milk and dairy products made from cows homozygous for beta casein A2 during 3 months. These products are also enriched in insaturated fatty acids and selenium. The daily intake reflects the habitual consumption habits. Recommended amounts are 250 mL of milk, a yogurt and 50 g fresh cheese per day.
- interventionNames
- Dietary Supplement: 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
- Dietary Supplement: 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
- Dietary Supplement: 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
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants (n=17) ingest conventional dairy products and milk daily during 3 months. As happens in the UNICLA-A2 arm, the daily intake reflects habitual dairy consumption habits in "real life" conditions, without forcing or inducing greater consumption. Therefore, recommended amounts are 250 mL of milk, a yogurt and 50 g fresh cheese per day.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.