Colorectal CancerNCT07819539
Anthocyanin-Rich Berry Supplementation in Patients With Colorectal Cancer
A study testing Anthocyanin-Rich Freeze-Dried Berry Supplement in people with Colorectal Cancer, run by Jagiellonian University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Anthocyanin-Rich Freeze-Dried Berry Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePoland
- Study dates
- 24 May 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- (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
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Anthocyanins on the Immune Response During Colorectal Cancer Treatment in Patients Over 65 Years of Age Using Freeze-Dried Black Raspberry and Strawberry Extracts
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.
Read the detailed description
This prospective, open-label interventional study was conducted in patients with histologically confirmed colorectal adenocarcinoma undergoing standard oncological treatment. The study aimed to evaluate the effects of short-term oral supplementation with an anthocyanin-rich preparation derived from freeze-dried black raspberry and strawberry on inflammatory response and nutritional status, as well as to assess the feasibility and tolerability of the intervention.
Participants in the intervention group received a standardized anthocyanin-rich preparation providing approximately 600-700 mg of anthocyanins per day for 21 consecutive days, in addition to standard oncological treatment. The preparation was chemically characterized prior to its clinical use.
Clinical and laboratory assessments were performed at baseline before initiation of the intervention and subsequently at approximately 4 and 12 weeks. Assessments included clinical evaluation, anthropometric measurements, nutritional assessment using the Mini Nutritional Assessment (MNA/MNA-SF), and collection of peripheral blood samples. Laboratory analyses included selected inflammatory and biochemical biomarkers, including C-reactive protein (CRP), interleukins and tumor necrosis factor alpha (TNF-α), as well as selected growth factors and routine biochemical parameters.
The study included patients treated in a real-world oncology setting and receiving different standard treatment modalities according to clinical indications, including surgery, chemoradiotherapy, and systemic therapy. Standard oncological treatment was not modified as part of the study intervention.
A concurrent group of individuals without colorectal cancer undergoing colonoscopy was included to provide baseline comparative data. This group did not receive the study supplementation and was not followed longitudinally. Longitudinal analyses therefore focused on changes over time among participants receiving the anthocyanin-rich preparation.
The study was designed to characterize longitudinal changes in inflammatory and nutritional parameters during colorectal cancer treatment and to evaluate the feasibility and tolerability of short-term anthocyanin-rich berry supplementation in this clinical setting.
- Conditions
- Colorectal Cancer
- Being tested
- Anthocyanin-Rich Freeze-Dried Berry Supplement
- Keywords
- Anthocyanins, colorectal cancer, systemic inflammation, inflammatory biomarkers, C-reactive protein, supportive care, functional food
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anthocyanin-Rich Freeze-Dried Berry SupplementDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Anthocyanin-Rich Berry Supplementation | Experimental | Not described Receives: Dietary Supplement: Anthocyanin-Rich Freeze-Dried Berry Supplement |
| Baseline comparator group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 4, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start24 May 2023
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksander Konturek, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819539
- Sponsor's protocol ID
- 1072.6120.80.2022
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared, in accordance with participant confidentiality and applicable data protection requirements.
Publications
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.
PubMed 40899077
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anthocyanins on the Immune Response During Colorectal Cancer Treatment in Patients Over 65 Years of Age Using Freeze-Dried Black Raspberry and Strawberry Extracts
- ClinicalTrials.gov ID
- NCT07819539
- Acronym / sponsor ID
- 1072.6120.80.2022
- Conditions
- Colorectal Cancer
- Keywords
- Anthocyanins, colorectal cancer, systemic inflammation, inflammatory biomarkers, C-reactive protein, supportive care, functional food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective, open-label interventional study was conducted in patients with histologically confirmed colorectal adenocarcinoma undergoing standard oncological treatment. The study aimed to evaluate the effects of short-term oral supplementation with an anthocyanin-rich preparation derived from freeze-dried black raspberry and strawberry on inflammatory response and nutritional status, as well as to assess the feasibility and tolerability of the intervention.
Participants in the intervention group received a standardized anthocyanin-rich preparation providing approximately 600-700 mg of anthocyanins per day for 21 consecutive days, in addition to standard oncological treatment. The preparation was chemically characterized prior to its clinical use.
Clinical and laboratory assessments were performed at baseline before initiation of the intervention and subsequently at approximately 4 and 12 weeks. Assessments included clinical evaluation, anthropometric measurements, nutritional assessment using the Mini Nutritional Assessment (MNA/MNA-SF), and collection of peripheral blood samples. Laboratory analyses included selected inflammatory and biochemical biomarkers, including C-reactive protein (CRP), interleukins and tumor necrosis factor alpha (TNF-α), as well as selected growth factors and routine biochemical parameters.
The study included patients treated in a real-world oncology setting and receiving different standard treatment modalities according to clinical indications, including surgery, chemoradiotherapy, and systemic therapy. Standard oncological treatment was not modified as part of the study intervention.
A concurrent group of individuals without colorectal cancer undergoing colonoscopy was included to provide baseline comparative data. This group did not receive the study supplementation and was not followed longitudinally. Longitudinal analyses therefore focused on changes over time among participants receiving the anthocyanin-rich preparation.
The study was designed to characterize longitudinal changes in inflammatory and nutritional parameters during colorectal cancer treatment and to evaluate the feasibility and tolerability of short-term anthocyanin-rich berry supplementation in this clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anthocyanin-Rich Berry Supplementation | Experimental | Dietary Supplement: Anthocyanin-Rich Freeze-Dried Berry Supplement |
| Baseline comparator group | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- (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
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anthocyanin-Rich Freeze-Dried Berry SupplementParticipants 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 | Dietary supplement | Anthocyanin-Rich Berry Supplementation |
Primary outcome
Change in Inflammatory Biomarkers
Time frame: Baseline, Week 4, and Week 12
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 40899077Jaglarz-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.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared, in accordance with participant confidentiality and applicable data protection requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anthocyanin-Rich Freeze-Dried Berry Supplement in people with Colorectal Cancer, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Inflammatory Biomarkers (time frame: Baseline, Week 4, and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07819539, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.