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

NCT04824053 | Recruiting

• 1 other identifier: F19-028.0
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Colorectal Polyp

Keywords

polyp; inflammation; fecal microbiota

Outcome Measures

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

  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 (2)

• Change from baseline in fecal microbiota.

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

• To assess the effect of treatment on colorectal adenoma recurrence

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

Study Arms (2)

UNICLA-A2 milk and its subproducts

EXPERIMENTAL

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.

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

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Conventional milk; Dietary Supplement: Conventional yogurt; Dietary Supplement: Conventional fresh cheese

Interventions

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

Also known as: UNICLA-A2 milk

UNICLA-A2 milk and its subproducts

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

Placebo

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

Also known as: UNICLA-A2 yogurt

UNICLA-A2 milk and its subproducts

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

Placebo

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

Also known as: UNICLA-A2 fresh cheese

UNICLA-A2 milk and its subproducts

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead
• Cooperativas Lacteas Unidas: collaborator
• Hospital Clínico Universitario Lozano Blesa: collaborator

Study Sites (1)

Angel Lanas Arbeloa

Zaragoza, Zaragoza, 50009, Spain

RECRUITING

Related Links

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MeSH Terms

Conditions

Polyps; Inflammation

Interventions

Selenium

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals

Study Officials

• Angel Lanas Arbeloa, MD, PhD

  University Hospital Lozano Blesa. IIS Aragón. CIBER de Enfermedades Hepáticas y Digestivas.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angel Lanas Arbeloa, MD, PhD

CONTACT

0034 976 76 57 86; alanas@unizar.es

Pilar Irun, PhD

CONTACT

mpirun.uit@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Digestive Service (University Clinic Hospital Lozano Blesa) and Principal Investigator

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 1, 2021
• Study Start: February 28, 2022
• Primary Completion: November 30, 2025
• Study Completion (Estimated): December 15, 2026
• Last Updated: February 27, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)