Effect of Aronia Berry Consumption on Inflammatory Parameters

Condition(s) studied

Investigational drug(s) / intervention(s)

Black chokeberry (Aronia melanocarpa): The aronia group, who will consume 30 g of freeze-dried aronia powder (n=25)

Placebo powder: The placebo group, who will consume placebo powder (n=25).

Study summary

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.

Eligibility

Primary outcome measure(s)

• C-Reactive Protein (CRP) — 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) — 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) — 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-6 (IL-6) — 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).
• Interleukin-8 (IL-8) — 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) — 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) — 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).
• Total Oxidant Status (TOS) — 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) — 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) — 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.

Trial sites (1)

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