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临床试验/NCT07819539
NCT07819539已完成不适用

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

Jagiellonian University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年5月24日最近更新:
适应症
干预措施

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

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

Experimental

干预措施: Anthocyanin-Rich Freeze-Dried Berry Supplement (Dietary Supplement)

Baseline comparator group

No Intervention

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

发起方
Jagiellonian University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aleksander Konturek

Professor

Jagiellonian University

研究点 (1)

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