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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Inflammatory Biomarkers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(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 ≤
- •(5)Age ≥65 years
排除标准
- •(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.
研究组 & 干预措施
Anthocyanin-Rich Berry Supplementation
干预措施: Anthocyanin-Rich Freeze-Dried Berry Supplement (Dietary Supplement)
Baseline comparator group
结局指标
主要结局
Change in Inflammatory Biomarkers
时间窗: 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.
次要结局
未报告次要终点
研究者
Aleksander Konturek
Professor
Jagiellonian University
