A Phase 4 interventional study of Verisol Collagen 2,5 g/day and Peptech Collagen 2,5 g/day in Collagen Supplementation, Whey Protein and Pulmonary Rehabilitation, sponsored by Federal University of São Paulo. Active, not recruiting at 1 site in Brazil. Open to participants aged 45 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by Federal University of São Paulo · Phase 4, Interventional, and Health services research
Chronic obstructive pulmonary disease (COPD) induces a severe loss of muscle strength and mass, in addition to reflecting significant pulmonary changes and causing cardiovascular, immunohematological, and renal alterations. In this regard, strategies capable of restoring or at least slowing the loss of muscle strength and mass are highly desirable. In this context, in addition to pulmonary rehabilitation with aerobic and strength exercises, supplementation with whey protein has been considered the gold standard for promoting muscle strength and mass gain in athletes. However, the potential effects of whey protein supplementation in patients with COPD remain unclear, which constitutes one of the objectives of the present study. A high percentage of elderly individuals present with lactose intolerance, milk protein allergies, or discomfort caused by components such as albumin, lactoferrin, casein, and alpha- and beta-globulin, making whey protein supplementation prohibitive for many elderly individuals, including those with COPD. Conversely, supplementation with collagen, particularly hydrolyzed collagen, offers a "pre-digested" protein option free from typical milk proteins. Additionally, the food industry has developed low molecular weight hydrolyzed collagen peptides, which may render such products hypoallergenic. To investigate these effects, 320 individuals aged 45 to 80 years with mild, moderate, severe, or very severe COPD (as defined by GOLD COPD 2025 criteria) will be recruited. Participants will be randomly assigned to four groups: Control Group (GC; subjected only to pre- and post-assessments; mild COPD n = 20; moderate COPD n = 20; severe COPD n = 20; very severe COPD n = 20), Whey Supplemented Group (GW; supplemented with whey protein; mild COPD n = 20; moderate COPD n = 20; severe COPD n = 20; very severe COPD n = 20), Hydrolyzed Collagen Supplemented Group (GH; supplemented with hydrolyzed collagen; mild COPD n = 20; moderate COPD n = 20; severe COPD n = 20; very severe COPD n = 20), and Rehabilitation Group (GR; subjected to rehabilitation; mild COPD n = 20; moderate COPD n = 20; severe COPD n = 20; very severe COPD n = 20). As outlined in the objectives and methodology of the project, the primary goals are to evaluate: (1) the effects of whey protein and (2) the effects of low molecular weight hydrolyzed collagen on pulmonary, cardiovascular, immunohematological, muscular, and renal parameters. The supplementation period will span three months, with evaluations conducted at baseline and after the supplementation period. Statistical analyses will be performed using the paired Student's t-test for intragroup comparisons and the unpaired Student's t-test for intergroup comparisons. A p-value of less than 0.05 will be considered statistically significant.
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's planned enrollment of 320 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
As an inclusion criterion, patients with COPD must be included and must have been undergoing clinical-medication treatment for at least 90 days. As exclusion criteria, they should not have any type of autoimmune disease, must not be active smokers for at least 1 year, and in the case of ex-smokers, they must have quit smoking for at least 3 years, and must not have been engaging in any regular physical activity (˃1x/week) for at least 1 year.
Supplementation with Verisol® collagen will be administered at a dose of 2.5 g/day, diluted in water or water-based juice (300-500 ml), and should be consumed daily for 7 days a week, over a period of 3 months.
Dietary Supplement: Verisol Collagen 2,5 g/day
Peptech® collagen will be administered at a dose of 2.5 g/day, diluted in water or water-based juice (300-500 ml), and should be consumed daily, 7 days a week, for 3 months.
Dietary Supplement: Peptech Collagen 2,5 g/day
Peptech® collagen supplementation at a dose of 10 g/day, diluted in water or water-based juice (300-500 ml), should be consumed daily, 7 days a week, for 3 months
Dietary Supplement: Peptech Collagen 10 g/day
The control group will not receive any intervention during the first three months. After the evaluations, they will begin supplementation for an additional three months.
Diagnostic Test: Cardiorespiratory test
Other: Pulmonary rehabilitation with aerobic and resistance training.
Patients allocated to this group will consume Verisol Collagen 2,5 g/day for 90 days.
Patients allocated to this group will consume Peptech Collagen 2,5 g/day for 90 days.
Patients allocated to this group will consume Peptech Collagen 10 g/day for 90 days.
Patients enroled in this group will be submitted to Pulmonary rehabilitation with aerobic and resistance training.
The patients allocated to this group will be submitted to initial and final evaluations only.
Plasma Concentrations of Inflammatory and Regulatory Biomarkers
Plasma levels of IL-1β, IL-1ra, IL-6, IL-8, IL-10, IL-17, IL-23, IL-33, TNF-α, TGF-β, VEGF, and Klotho will be measured to evaluate the effect of supplementation with: 10 g/day of whey protein isolate, 2.5 g/day of Verisol® collagen, 2.5 g/day of Peptech® collagen (low molecular weight peptides), and 10 g/day of Peptech® collagen (low molecular weight peptides). Biomarkers will be quantified using enzyme-linked immunosorbent assay (ELISA) kits, following the manufacturer's instructions and international laboratory standards. Blood samples will be collected at two specific time points: baseline (prior to supplementation) and after three months of intervention. Data Aggregation: Mean and standard deviation of plasma concentrations for each biomarker within each group, with intra- and intergroup comparisons of pre- and post-intervention levels.
Time frame: Baseline and after 3 months of intervention
Pulmonary Function Assessed by Spirometry
Pulmonary function will be assessed using spirometry, following the parameters and guidelines established by the Sociedade Brasileira de Pneumologia e Tisiologia (SBPT). The following spirometric variables will be measured: Forced Vital Capacity (FVC), Forced Expiratory Volume in the first second (FEV1), FEV1/FVC ratio, Peak Expiratory Flow (PEF). Assessments will be performed at two specific time points: baseline (prior to supplementation) and after three months of intervention. Spirometry will be conducted by trained professionals using calibrated equipment, adhering to quality control standards recommended by the SBPT. Data Aggregation: Mean and standard deviation for each spirometric variable within each group, with intra- and intergroup comparisons of pre- and post-intervention values.
Time frame: Baseline and after 3 months of intervention.
Cardiovascular Hemodynamics Assessed by PhysioFlow Impedance Cardiography
Cardiovascular hemodynamics will be assessed non-invasively using PhysioFlow impedance cardiography. The following parameters will be measured: Stroke Volume and Stroke Volume Index, Cardiac Output and Cardiac Output Index, Early Diastolic Filling Ratio (Preload Index), and Systemic Vascular Resistance (Afterload). Assessments will be performed at two specific time points: baseline (prior to supplementation) and after three months of intervention. Measurements will be conducted by trained professionals using calibrated equipment, following the manufacturer's recommendations and quality control standards. Data will be aggregated as mean and standard deviation for each parameter within each group, with intra- and intergroup comparisons of pre- and post-intervention values. Data Aggregation: Mean and standard deviation for each cardiovascular parameter within each group, with intra- and intergroup comparisons of pre- and post-intervention values.
Time frame: Baseline and after 3 months of intervention.
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Federal University of São Paulo