Consumption of Anti-Inflammatory Effects of Aronia (Aronia Melanocarpa) Berry in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- C-Reactive Protein (CRP)
研究概览
简要总结
The study will aim to evaluate the effects of consuming freeze-dried aronia berries as an adjunct to medical treatment in patients with chronic obstructive pulmonary disease (COPD), focusing on anti-inflammatory, respiratory, and biochemical parameters.
It will be conducted at a research hospital in Istanbul, involving 50 participants aged 50-80 diagnosed with COPD. Participants will be randomly assigned to two groups: the aronia group (AG, n=25) and the placebo group (PG, n=25). The AG will receive 30 g of freeze-dried aronia powder daily, while the PG will receive 30 g of placebo powder, both for a duration of 8 weeks. Baseline demographic data will be collected through face-to-face interviews, while biochemical, respiratory, anthropometric, and body composition parameters will be assessed both before and after the intervention. Dietary intake records will also be collected and analyzed.
详细描述
Participant Selection This study will be conducted between November 15, 2024, and November 15, 2025, at the Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital Pulmonology Outpatient Clinic. Participants will include patients who will be diagnosed with COPD by a physician. The diagnosis of COPD will be based on spirometry, specifically when Forced Expiratory Volume in 1 second): FEV1 is below 80% of the predicted value.
COPD cases will be classified according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2020 Guidelines. Post-bronchodilator FEV1 values will categorize patients into mild (FEV1 ≥ 80% predicted), moderate (50% ≤ FEV1 < 80% predicted), severe (30% ≤ FEV1 < 50% predicted), or very severe (FEV1 < 30% predicted). Sample size calculations will assume a detectable change of 0.67 pg/mL in the primary outcome variable (Tumor Necrosis Factor-alpha, TNF-α) at a significance level of 0.05 and a power of 0.80. These calculations will be performed using the software available at http://hedwig.mgh.harvard.edu/sample\_size/js/js\_crossover\_quant.html.
Acquisition and Preparation of Aronia Berries Aronia berries (Aronia melanocarpa) will be obtained in season from the Atatürk Horticultural Central Research Institute of the Turkish Ministry of Agriculture and Forestry. The berries will be freeze-dried using a TRS-2-4 lyophilizer at -55°C. A single fruit exchange (containing 15 g of carbohydrates) will correspond to 200 g of lyophilized aronia berries, which will be vacuum-packed for participant use.
Study Design This study will be designed as a randomized, placebo-controlled, double-blind trial. Patients diagnosed with COPD at the Yedikule Pulmonology Clinic and willing to volunteer will be included after providing informed consent. Fifty participants (25 male, 25 female) who meet the study criteria will be randomized into two groups using a sealed envelope method.
The placebo will consist of maltodextrin combined with oil-based berry flavoring, citric acid, powdered sugar, pink-black food coloring, and liquid oil as a solvent for the flavoring. Placebos will be provided in 30 g vacuum-sealed packets and will be indistinguishable from the aronia supplements in color and weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 50-80 years
- •Diagnosed with COPD
- •Not following a vegetarian or vegan diet
- •Willing to consume the provided aronia berry (black chokeberry)
- •Non-smokers
- •Have signed the informed consent form
- •Has not undergone endobronchial tube or valve surgery in the last two years.
排除标准
- •Presence of associated chronic inflammatory/rheumatic diseases
- •Chronic infections that may create a prothrombotic state
- •Chronic kidney disease (CKD)
- •Malignancy
- •Hereditary thrombophilia
- •Essential thrombocythemia
- •Diagnosed endocrine disorders
- •Malabsorption disorders
- •Allergy to any food or berry fruits
- •Participants who did not sign the informed consent form
研究组 & 干预措施
Aronia group
The Aronia group will consume 30 g of freeze-dried aronia powder (n=25).
干预措施: Black chokeberry (Aronia melanocarpa) (Dietary Supplement)
Placebo group
The placebo group will consume placebo powder (n=25).
干预措施: Placebo powder (Other)
结局指标
主要结局
C-Reactive Protein (CRP)
时间窗: Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).
Serum CRP levels will be measured to evaluate systemic inflammation in participants. The results will be reported in picograms per milliliter (pg/mL).
Tumor Necrosis Factor-Alpha (TNF-Alpha)
时间窗: Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).
Serum TNF-alpha levels will be analyzed as a marker of inflammation. The results will be reported in nanograms per liter (ng/L).
Interleukin-1 Beta (IL-1β)
时间窗: Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).
Serum IL-1β levels in serum will be measured as an indicator of pro-inflammatory activity. Results will be reported in picograms per milliliter (pg/mL).
Interleukin-8 (IL-8)
时间窗: Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).
Serum IL-8 levels will be assessed as a biomarker of inflammation. The measurements will be conducted using enzyme-linked immunosorbent assay (ELISA) and reported in nanograms per liter (ng/L).
Interleukin-10 (IL-10)
时间窗: Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).
Serum IL-10 levels will be assessed as a biomarker of inflammation. The measurements will be conducted using enzyme-linked immunosorbent assay (ELISA) and reported in picograms per milliliter (pg/mL).
Total Antioxidant Status (TAS)
时间窗: Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).
TAS will be measured spectrophotometrically to evaluate the total antioxidant capacity in serum. Results will be expressed as millimoles per liter ascorbate equivalent (mmol/L Ascorbate Eq). TAS and Total Oxidant Status (TOS) will be combined to report Oxidative Stress Index (OSI).
Interleukin-6 (IL-6)
时间窗: Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).
Serum IL-6 levels will be assessed as a biomarker of inflammation. The measurements will be conducted using enzyme-linked immunosorbent assay (ELISA) and reported in nanograms per liter (ng/L).
Total Oxidant Status (TOS)
时间窗: Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).
TOS will be analyzed spectrophotometrically to assess the overall oxidative stress in serum. Results will be expressed as micromoles of hydrogen peroxide equivalent per liter (µmol H2O2 Eq/L). TAS and TOS will be combined to report Oxidative Stress Index (OSI).
The Oxidative Stress Index (OSI)
时间窗: Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).
(OSI) is calculated as the ratio of TOS to TAS. This ratio represents the balance between oxidants and antioxidants in a system. Result will be expressed as an arbitrary unit (AU).
COPD Assessment Test (CAT)
时间窗: Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).
The COPD Assessment Test will be used to evaluate the health status of participants with COPD. The CAT score will range from 0 to 40, with higher scores indicating greater health impairment.
次要结局
- Forced Vital Capacity (FVC)(Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).)
- Forced Expiratory Volume in 1 Second (FEV1)(Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).)
- FVC/FEV1 Ratio(Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).)
研究者
Buse Sarıkaya
Principal Investigator Research Assistant Dr. Buse Sarıkaya
Amasya University