Collagen SupplementationPhase 4NCT07011225
Effects of Rehabilitation and Supplementation With Hydrolyzed Collagen vs. Whey Protein on the Cardiopulmonary, Renal, Muscular, and Immunohematological Response of COPD Patients
A Phase 4 study testing Verisol Collagen 2,5 g/day, Peptech Collagen 2,5 g/day and Peptech Collagen 10 g/day in people with Collagen Supplementation and Whey Protein, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Collagen Supplementation, Whey Protein, Pulmonary Rehabilitation
- What is being tested?
- Verisol Collagen 2,5 g/day, Peptech Collagen 2,5 g/day and Peptech Collagen 10 g/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Aug 2024to 15 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Collagen Supplementation, Whey Protein, Pulmonary Rehabilitation, COPD - Chronic Obstructive Pulmonary Disease
- Being tested
- Verisol Collagen 2,5 g/day, Peptech Collagen 2,5 g/day, Peptech Collagen 10 g/day, Pulmonary rehabilitation with aerobic and resistance training., Cardiorespiratory test
- Keywords
- COPD, Pulmonary Inflammation, Pulmonary Rehabilitation, Dietary Supplementation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verisol Collagen 2,5 g/dayDietary supplement
Patients allocated to this group will consume Verisol Collagen 2,5 g/day for 90 days.
Peptech Collagen 2,5 g/dayDietary supplement
Patients allocated to this group will consume Peptech Collagen 2,5 g/day for 90 days.
Peptech Collagen 10 g/dayDietary supplement
Patients allocated to this group will consume Peptech Collagen 10 g/day for 90 days.
Pulmonary rehabilitation with aerobic and resistance training.Other
Patients enroled in this group will be submitted to Pulmonary rehabilitation with aerobic and resistance training.
Cardiorespiratory testDiagnostic test
The patients allocated to this group will be submitted to initial and final evaluations only.
| Study group | Role | What they receive |
|---|---|---|
| Verisol Collagen 2.5 g/day (GCV) | Experimental | 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. Receives: Dietary Supplement: Verisol Collagen 2,5 g/day |
| Peptech Collagen 2.5 g/day (GCP 2.5) | Experimental | 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. Receives: Dietary Supplement: Peptech Collagen 2,5 g/day |
| Peptech Collagen 10 g/day (GCP 10) | Experimental | 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 Receives: Dietary Supplement: Peptech Collagen 10 g/day |
| Group Control | Experimental | 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. Receives: Diagnostic Test: Cardiorespiratory test |
| Pulmonary rehabilitation with aerobic and resistance training. | Experimental | Not described Receives: Other: Pulmonary rehabilitation with aerobic and resistance training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 3 months of intervention
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline and after 3 months of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start26 Aug 2024
- Primary completion20 Dec 2024
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Collagen SupplementationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The volunteers will be randomly assigned to 4 groups, as follows: Control Group (GC; group only subjected to pre- and post-assessment; mild COPD n = 20; moderate COPD n = 20; severe COPD n = 20; very severe COPD n = 20), Whey Supplemented Group (GW; group 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; group supplemented with hydrolyzed collagen; mild COPD n = 20; moderate COPD n = 20; severe COPD n = 20; very severe COPD n = 20), Rehabilitation Group (GR; group subjected to rehabilitation; mild COPD n = 20; moderate COPD n = 20; severe COPD n = 20; very severe COPD n = 20). We clarify that the evaluations will be conducted before and after the rehabilitation period (nutritional supplementation).
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodolfo de Paula Vieira, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011225
- Sponsor's protocol ID
- 7.040.417
- Status last verified
- May 2025
- First submitted
- 11 Mar 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rehabilitation and Supplementation With Hydrolyzed Collagen vs. Whey Protein on the Cardiopulmonary, Renal, Muscular, and Immunohematological Response of COPD Patients
- ClinicalTrials.gov ID
- NCT07011225
- Acronym / sponsor ID
- 7.040.417
- Conditions
- Collagen Supplementation, Whey Protein, Pulmonary Rehabilitation, COPD - Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Pulmonary Inflammation, Pulmonary Rehabilitation, Dietary Supplementation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- The volunteers will be randomly assigned to 4 groups, as follows: Control Group (GC; group only subjected to pre- and post-assessment; mild COPD n = 20; moderate COPD n = 20; severe COPD n = 20; very severe COPD n = 20), Whey Supplemented Group (GW; group 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; group supplemented with hydrolyzed collagen; mild COPD n = 20; moderate COPD n = 20; severe COPD n = 20; very severe COPD n = 20), Rehabilitation Group (GR; group subjected to rehabilitation; mild COPD n = 20; moderate COPD n = 20; severe COPD n = 20; very severe COPD n = 20). We clarify that the evaluations will be conducted before and after the rehabilitation period (nutritional supplementation).
| Arm | Type | Receives |
|---|---|---|
| Verisol Collagen 2.5 g/day (GCV) | Experimental | Dietary Supplement: Verisol Collagen 2,5 g/daySupplementation 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. |
| Peptech Collagen 2.5 g/day (GCP 2.5) | Experimental | Dietary Supplement: Peptech Collagen 2,5 g/dayPeptech® 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. |
| Peptech Collagen 10 g/day (GCP 10) | Experimental | Dietary Supplement: Peptech Collagen 10 g/dayPeptech® 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 |
| Group Control | Experimental | Diagnostic Test: Cardiorespiratory testThe control group will not receive any intervention during the first three months. After the evaluations, they will begin supplementation for an additional three months. |
| Pulmonary rehabilitation with aerobic and resistance training. | Experimental | Other: Pulmonary rehabilitation with aerobic and resistance training. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verisol Collagen 2,5 g/dayPatients allocated to this group will consume Verisol Collagen 2,5 g/day for 90 days. | Dietary supplement | Verisol Collagen 2.5 g/day (GCV) |
| Peptech Collagen 2,5 g/dayPatients allocated to this group will consume Peptech Collagen 2,5 g/day for 90 days. | Dietary supplement | Peptech Collagen 2.5 g/day (GCP 2.5) |
| Peptech Collagen 10 g/dayPatients allocated to this group will consume Peptech Collagen 10 g/day for 90 days. | Dietary supplement | Peptech Collagen 10 g/day (GCP 10) |
| Pulmonary rehabilitation with aerobic and resistance training.Patients enroled in this group will be submitted to Pulmonary rehabilitation with aerobic and resistance training. | Other | Pulmonary rehabilitation with aerobic and resistance training. |
| Cardiorespiratory testThe patients allocated to this group will be submitted to initial and final evaluations only. | Diagnostic test | Group Control |
Primary outcome
Plasma Concentrations of Inflammatory and Regulatory Biomarkers
Time frame: Baseline and after 3 months of intervention
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.
2 secondary outcomes
Pulmonary Function Assessed by Spirometry
Time frame: Baseline and after 3 months of intervention.
Cardiovascular Hemodynamics Assessed by PhysioFlow Impedance Cardiography
Time frame: Baseline and after 3 months of intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Verisol Collagen 2,5 g/day, Peptech Collagen 2,5 g/day and Peptech Collagen 10 g/day in people with Collagen Supplementation and Whey Protein, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Concentrations of Inflammatory and Regulatory Biomarkers (time frame: Baseline and after 3 months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.