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临床试验/NCT07011225
NCT07011225进行中(未招募)4 期

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

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2024年8月26日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
进行中(未招募)
发起方
入组人数
320
试验地点
1
主要终点
Plasma Concentrations of Inflammatory and Regulatory Biomarkers

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •, 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.

研究组 & 干预措施

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.

干预措施: Peptech Collagen 2,5 g/day (Dietary Supplement)

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

干预措施: Peptech Collagen 10 g/day (Dietary Supplement)

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.

干预措施: Verisol Collagen 2,5 g/day (Dietary Supplement)

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.

干预措施: Cardiorespiratory test (Diagnostic Test)

Pulmonary rehabilitation with aerobic and resistance training.

Experimental

干预措施: Pulmonary rehabilitation with aerobic and resistance training. (Other)

结局指标

主要结局

Plasma Concentrations of Inflammatory and Regulatory Biomarkers

时间窗: 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.

次要结局

  • 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.)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rodolfo de Paula Vieira

Principal Investigator

Federal University of São Paulo

研究点 (1)

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