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

ConditionColorectal Polyp
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInstituto de Investigación Sanitaria Aragón

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

At least 10 adenomas

At least 5 proximal serrated polyps (PSP)

At least 2 serrated polyps with diameters ≥10 mm

Serrated Polyposis Syndrome (SPS)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

    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

    Dietary supplement

    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

    Dietary supplement

    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

    Dietary supplement

    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

    Dietary supplement

    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

    Dietary supplement

    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

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: UNICLA-A2 milk and its subproductsExperimental treatment 3 interventions
Group B: PlaceboPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.

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

Time frame
At baseline, at 3 months and through study completion, an average of 1 year after the colonoscopy that motivated the patient´s inclusion

Secondary outcomes

1

Change from baseline in fecal microbiota.

Stool samples are collected for DNA extraction and ulterior metagenomic analysis of the fecal microbiota's composition. Library construction is carried out with the Ion 16S™ Metagenomics Kit which permits PCR amplification of hypervariable regions of the 16S rDNA gene from bacteria and the material obtained is subjected to next-generation sequencing (NGS) to see the proportions of the main groups of microorganisms in the sample.

Time frame
At baseline, at 3 months and through study completion, an average of 1 year after the colonoscopy that motivated the patient´s inclusion
2

To assess the effect of treatment on colorectal adenoma recurrence

The number of participants in each arm who develop one or more colorectal adenomas is determined in the follow-up colonoscopy (adenoma detection rate), as well as the presence of advanced or not advanced adenomas, serrated polyps, subtype, location and the total number of adenomas per participant.

Time frame
Through study completion, an average of 1 year after the initial colonoscopy that motivated the suitability of patients inclusion.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto de Investigación Sanitaria Aragón

Lead sponsor

Cooperativas Lacteas Unidas

Collaborator

Hospital Clínico Universitario Lozano Blesa

Collaborator

Source ClinicalTrials.gov
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