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

NCT07011225 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 7.040.417
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

COPD; Pulmonary Inflammation; Pulmonary Rehabilitation; Dietary Supplementation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and after 3 months of intervention

Secondary Outcomes (2)

• Pulmonary Function Assessed by Spirometry

  Baseline and after 3 months of intervention.

• Cardiovascular Hemodynamics Assessed by PhysioFlow Impedance Cardiography

  Baseline and after 3 months of intervention.

Study Arms (5)

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.

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.

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

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.

Diagnostic Test: Cardiorespiratory test

Pulmonary rehabilitation with aerobic and resistance training.

EXPERIMENTAL

Other: Pulmonary rehabilitation with aerobic and resistance training.

Interventions

Verisol Collagen 2,5 g/day DIETARY_SUPPLEMENT

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

Verisol Collagen 2.5 g/day (GCV)

Peptech Collagen 2,5 g/day DIETARY_SUPPLEMENT

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

Peptech Collagen 2.5 g/day (GCP 2.5)

Peptech Collagen 10 g/day DIETARY_SUPPLEMENT

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

Peptech Collagen 10 g/day (GCP 10)

Pulmonary rehabilitation with aerobic and resistance training. OTHER

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

Pulmonary rehabilitation with aerobic and resistance training.

Cardiorespiratory test DIAGNOSTIC_TEST

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

Group Control

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Evangelical University of Goiás

Anápolis, Goiás, 75083-515, Brazil

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Pneumonia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: June 8, 2025
• Study Start: August 26, 2024
• Primary Completion: December 20, 2024
• Study Completion (Estimated): December 15, 2027
• Last Updated: June 8, 2025

Record last verified: 2025-05

Locations

BR (1)