Anthocyanin-Rich Berry Supplementation in Patients With Colorectal Cancer

NCT07819539 | Completed

• 1 other identifier: 1072.6120.80.2022
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, open-label interventional study evaluated the effects of short-term supplementation with an anthocyanin-rich freeze-dried black raspberry and strawberry preparation in patients undergoing treatment for colorectal cancer. The study assessed the tolerability of the intervention and longitudinal changes in nutritional status and selected inflammatory and biochemical biomarkers. Participants received the anthocyanin-rich supplement for 21 consecutive days in addition to standard oncological treatment and were assessed at baseline and during follow-up.

Conditions

Colorectal Cancer

Keywords

Anthocyanins, colorectal cancer, systemic inflammation, inflammatory biomarkers, C-reactive protein, supportive care, functional food

Outcome Measures

Primary Outcomes (1)

• Change in Inflammatory Biomarkers

  Change in circulating inflammatory biomarkers, including C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-1 alpha (IL-1α), and tumor necrosis factor alpha (TNF-α), compared with baseline.

  Baseline, Week 4, and Week 12

Study Arms (2)

Anthocyanin-Rich Berry Supplementation

EXPERIMENTAL

Dietary Supplement: Anthocyanin-Rich Freeze-Dried Berry Supplement

Baseline comparator group

NO INTERVENTION

Interventions

Anthocyanin-Rich Freeze-Dried Berry Supplement DIETARY_SUPPLEMENT

Participants received a standardized oral anthocyanin-rich supplement derived from freeze-dried black raspberry and strawberry for 21 consecutive days. The supplement was administered at a dose of five tablets three times daily (15 tablets/day), providing approximately 600-700 mg of anthocyanins per day. Standard oncological treatment was continued according to clinical indications.The baseline comparator group consisted of individuals without colorectal cancer undergoing colonoscopy who did not receive anthocyanin supplementation. This group was included solely for comparison of baseline demographic, clinical, and laboratory parameters and did not participate in the longitudinal intervention phase

Anthocyanin-Rich Berry Supplementation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• (1) histologically confirmed primary colorectal adenocarcinoma; (2) qualification for surgical treatment, neoadjuvant chemoradiotherapy, or systemic chemotherapy; (3) ability to receive oral supplementation; and (4) Eastern Cooperative Oncology Group (ECOG) performance status ≤2. (5)Age ≥65 years

You may not qualify if:

• (1) gastrointestinal obstruction; (2) advanced cardiac or respiratory failure; (3) severe renal or hepatic insufficiency; and (4) food allergies or hypersensitivity that could interfere with administration of the study supplement.

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Tarnów Oncology Centre

Tarnów, Poland

Location

Related Publications (1)

• Jaglarz-Bialy K, Konturek A, Jagla J, Orzel A, Krol-Dyrek K, Fraczek J, Krosniak M. The analysis of the composition and antioxidant properties of freeze-dried chokeberry, strawberry, blackberry and selected raspberry fruits. Folia Med Cracov. 2024 Dec 30;64(4):47-57. doi: 10.24425/fmc.2024.153272.

  PMID: 40899077 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start: May 24, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)