Effect of Aronia Berry Consumption on Inflammatory Parameters

NCT06702696 | Recruiting

• 1 other identifier: SarikayaB.
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

anti-inflammatory; black chokeberry; COPD; aronia melanocarpa; cytokines

Outcome Measures

Primary Outcomes (10)

• C-Reactive Protein (CRP)

  Serum CRP levels will be measured to evaluate systemic inflammation in participants. The results will be reported in picograms per milliliter (pg/mL).

  Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).

• Tumor Necrosis Factor-Alpha (TNF-Alpha)

  Serum TNF-alpha levels will be analyzed as a marker of inflammation. The results will be reported in nanograms per liter (ng/L).

  Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).

• Interleukin-1 Beta (IL-1β)

  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).

  Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).

• Interleukin-6 (IL-6)

  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).

  Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).

• Interleukin-8 (IL-8)

  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).

  Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).

• Interleukin-10 (IL-10)

  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).

  Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).

• Total Antioxidant Status (TAS)

  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).

  Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).

• Total Oxidant Status (TOS)

  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).

  Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).

• The Oxidative Stress Index (OSI)

  (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).

  Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).

• COPD Assessment Test (CAT)

  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.

  Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).

Secondary Outcomes (3)

• 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).

Other Outcomes (14)

• Fasting Blood Glucose

  Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).

• Triglycerides (TG)

  Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).

• High-Density Lipoprotein (HDL)

  Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).

Study Arms (2)

Aronia group

EXPERIMENTAL

The Aronia group will consume 30 g of freeze-dried aronia powder (n=25).

Dietary Supplement: Black chokeberry (Aronia melanocarpa)

Placebo group

PLACEBO COMPARATOR

The placebo group will consume placebo powder (n=25).

Other: Placebo powder

Interventions

Black chokeberry (Aronia melanocarpa) DIETARY_SUPPLEMENT

The aronia group, who will consume 30 g of freeze-dried aronia powder (n=25)

Aronia group

Placebo powder OTHER

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

Placebo group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Smoking
• Participants who did not sign the informed consent form

Sponsors & Collaborators

• Amasya University: lead

Study Sites (1)

Yedikule Göğüs Hastalıkları Hastanesi

Istanbul, Zeytinburnu, 34020, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Buse Sarıkaya, PhD

CONTACT

05544615101; buse-sarikaya@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Research Assistant Dr. Buse Sarıkaya

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 25, 2024
• Study Start: November 15, 2024
• Primary Completion: September 15, 2025
• Study Completion: November 15, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

TU (1)