NCT07011225

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

Active, enrolled Phase 4 Last updated 8 June 2025

What this trial tests

Phase 4 trial testing Verisol Collagen 2,5 g/day in Collagen Supplementation in 320 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

26 August 2024

Primary endpoint
20 December 2024

15 December 2027

Quick facts

Lead sponsor	Federal University of São Paulo
Phase	Phase 4
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	320
Start date	26 August 2024
Primary completion	20 December 2024
Estimated completion	15 December 2027
Sites	1 location across Brazil

Drugs / interventions 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

Conditions studied

• Collagen Supplementation — all drugs for Collagen Supplementation →
• Whey Protein — all drugs for Whey Protein →
• Pulmonary Rehabilitation — all drugs for Pulmonary Rehabilitation →
• COPD - Chronic Obstructive Pulmonary Disease — all drugs for COPD - Chronic Obstructive Pulmonary Disease →

Sponsor

Federal University of São Paulo

Who can join

Adults 45 to 80, any sex, with Collagen Supplementation or Whey Protein. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.