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.
The intervention phase will last eight weeks. Physicians, researchers, and participants
will remain blinded to the type of product consumed (aronia or placebo). Participants
will record their dietary intake during the study, and a food diary will be collected for
nutritional assessment. Clinical evaluations will occur twice: at baseline and at the end
of the 8th week following randomization.
Data Collection and Assessment Data will be collected using a questionnaire developed by
the researchers based on literature reviews, administered via face-to-face interviews.
The questionnaire will include 20 questions covering demographics, health status,
physical activity, dietary habits, weight changes, and appetite loss over the past six
months. Participants will also complete a COPD Assessment Test (CAT) and record food
intake. Anthropometric measurements, spirometry, and biochemical tests will be conducted,
and blood samples will be collected for analysis.
To minimize daily variations, all assessments will be conducted between 8:00 and 10:00
AM, following an overnight fast (after 10:00 PM the previous night). At baseline,
participants will complete a demographic survey during face-to-face interviews, and all
participants will sign a written informed consent form.
Dietary Intake Records Participants' dietary intake will be evaluated before and after
the intervention using a one-day food record. The food records will be obtained through
face-to-face interviews and will include meal components, preparation methods,
quantities, measurements, and, for processed or enteral products, brand names.
Nutritional assessments will be performed using the BeBis 9.0 software, and results will
be compared with the Turkey Dietary Guidelines (TÜBER) to calculate the percentage of
daily nutrient requirements met. Intakes below 50% of daily recommendations will be
considered insufficient.
Body Composition and Anthropometric Measurements Body composition will be assessed using
bioelectrical impedance analysis (BIA) with an eight-electrode InBody 120 device (InBody
Co., Ltd., Istanbul, Turkey). Measurements will be conducted after a minimum of 8 hours
of fasting, with participants barefoot and standing in an upright position. Parameters
measured will include body weight (kg), skeletal muscle mass (kg), body fat mass (kg),
body fat percentage (%), total body water (L), and visceral fat level.
Anthropometric measurements will include height (m), waist circumference (cm), and mid
arm circumference. Height will be measured with a portable InBody stadiometer in a
standing position without shoes. Waist circumference will be measured at the midpoint
between the lowest rib and the iliac crest, while mid arm circumference will be taken
from the non-dominant arm at the midpoint between the acromion and olecranon.
Spirometry Lung function tests will be performed by trained spirometry technicians at the
hospital. Patients will take three normal breaths, then perform a maximum inhalation
followed by a forceful exhalation to measure Forced Expiratory Volume in 1 second (FEV1),
Forced Vital Capacity (FVC), and the FEV1/FVC ratio.
The FEV1 refers to the volume of air exhaled in the first second of the forced breath.
The FVC represents the total volume of air forcibly exhaled after a full inhalation. The
FEV1/FVC ratio, expressed as a percentage, indicates the proportion of the FVC exhaled
during the first second, serving as a key parameter for assessing airflow obstruction.
COPD Assessment Test (CAT) The CAT will evaluate the impact of COPD on patients' lives,
including symptoms such as cough, sputum, breathlessness, fatigue, and confidence in
leaving home. Validity and reliability for Turkish patients were established by
Yorgancıoğlu et al. The CAT is an eight-item, self-administered questionnaire, each item
is scored on a scale of 0 to 5, resulting in a total score ranging from 0 to 40, with
higher scores indicating greater health impairment.
Biochemical Analyses Blood samples (5 mL) will be collected from fasting participants,
centrifuged at 3000 g for 10 minutes, and stored in serum separator tubes. Serum samples
will be preserved using a cold chain for biochemical analysis. Further details regarding
the analyses will be available in the study protocol