Effects of Rehabilitation and Supplementation With Hydrolyzed Collagen vs. Whey Protein on the Cardiopulmonary, Renal, Muscular, and Immunohematological Response of COPD Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-26

Study Completion Date

2027-12-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Collagen Supplementation Whey Protein Pulmonary Rehabilitation COPD - Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Verisol Collagen 2.5 g/day (GCV)

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.

Group Type EXPERIMENTAL

Verisol Collagen 2,5 g/day

Intervention Type DIETARY_SUPPLEMENT

Patients allocated to this group will consume Verisol Collagen 2,5 g/day for 90 days.

Peptech Collagen 2.5 g/day (GCP 2.5)

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.

Group Type EXPERIMENTAL

Peptech Collagen 2,5 g/day

Intervention Type DIETARY_SUPPLEMENT

Patients allocated to this group will consume Peptech Collagen 2,5 g/day for 90 days.

Peptech Collagen 10 g/day (GCP 10)

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

Group Type EXPERIMENTAL

Peptech Collagen 10 g/day

Intervention Type DIETARY_SUPPLEMENT

Patients allocated to this group will consume Peptech Collagen 10 g/day for 90 days.

Group Control

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.

Group Type EXPERIMENTAL

Cardiorespiratory test

Intervention Type DIAGNOSTIC_TEST

The patients allocated to this group will be submitted to initial and final evaluations only.

Pulmonary rehabilitation with aerobic and resistance training.

Group Type EXPERIMENTAL

Pulmonary rehabilitation with aerobic and resistance training.

Intervention Type OTHER

Patients enroled in this group will be submitted to Pulmonary rehabilitation with aerobic and resistance training.

Interventions

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Verisol Collagen 2,5 g/day

Patients allocated to this group will consume Verisol Collagen 2,5 g/day for 90 days.

Intervention Type DIETARY_SUPPLEMENT

Peptech Collagen 2,5 g/day

Patients allocated to this group will consume Peptech Collagen 2,5 g/day for 90 days.

Intervention Type DIETARY_SUPPLEMENT

Peptech Collagen 10 g/day

Patients allocated to this group will consume Peptech Collagen 10 g/day for 90 days.

Intervention Type DIETARY_SUPPLEMENT

Pulmonary rehabilitation with aerobic and resistance training.

Patients enroled in this group will be submitted to Pulmonary rehabilitation with aerobic and resistance training.

Intervention Type OTHER

Cardiorespiratory test

The patients allocated to this group will be submitted to initial and final evaluations only.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

As an inclusion criterion, patients with COPD must be included and must have been undergoing clinical-medication treatment for at least 90 days.

Exclusion Criteria

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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes