Effect of Aronia Berry Consumption on Inflammatory Parameters
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorAmasya University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Aged 50-80 years
Diagnosed with COPD
Not following a vegetarian or vegan diet
Willing to consume the provided aronia berry (black chokeberry)
Disqualifiers
Presence of associated chronic inflammatory/rheumatic diseases
Chronic infections that may create a prothrombotic state
Chronic kidney disease (CKD)
Malignancy
Trial design
Design model
Parallel
Treatments tested in this trial
Black chokeberry (Aronia melanocarpa)
Dietary supplementThe aronia group, who will consume 30 g of freeze-dried aronia powder (n=25)
Placebo powder
Other interventionThe placebo group, who will consume placebo powder (n=25).
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Aronia groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).2
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).
Time frame
Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).3
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).
Time frame
Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).4
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).
Time frame
Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).Secondary outcomes
1
Forced Vital Capacity (FVC)
FVC will be assessed using spirometry and reported in liters (L). The assessment will measure the maximum volume of air a participant can forcibly exhale after a full inhalation. FVC and Forced Expiratory Volume in 1 Second (FEV1) will combined to report FVC/FEV1 ratio.
Time frame
Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).2
Forced Expiratory Volume in 1 Second (FEV1)
FEV1 will be measured using spirometry and reported in liters (L). The test evaluates the volume of air exhaled in the first second of a forceful exhalation. FVC and FEV1 will combined to report FVC/FEV1 ratio.
Time frame
Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).3
FVC/FEV1 Ratio
The ratio of forced vital capacity (FVC) to forced expiratory volume in 1 second (FEV1) will be calculated to assess airflow limitation. Results will be expressed as a percentage.
Time frame
Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).Other outcomes
1
Fasting Blood Glucose
Fasting blood glucose levels will be measured to assess participants' glycemic control. Results will be reported in milligrams per deciliter (mg/dL) and reflect glucose concentration after an overnight fast.
Time frame
Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).2
Triglycerides (TG)
Triglyceride levels will be measured to assess lipid metabolism. Results will be expressed in milligrams per deciliter (mg/dL).
Time frame
Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).3
High-Density Lipoprotein (HDL)
HDL cholesterol levels will be measured to evaluate cardiovascular risk. Results will be reported in milligrams per deciliter (mg/dL).
Time frame
Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).4
Low-Density Lipoprotein (LDL)
LDL cholesterol levels will be assessed to understand lipid-related cardiovascular risk. Results will be expressed in milligrams per deciliter (mg/dL).
Time frame
Baseline (T0, 1 week before the beginning of the study); T1 (8 weeks after the end of the treatment/control period).Sponsors and contacts
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Source ClinicalTrials.gov