跳至主要内容
临床试验/NCT06240429
NCT06240429已完成不适用

Collagen Peptide Supplementation and Physical Exercise in Adults Over 55 Years of Age: A Randomized, Double-blind, Placebo-Controlled Clinical Trial

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
2
主要终点
Sit and Stand test

研究概览

简要总结

It is known that the consumption of proteins, and their consequent hyperaminoacidemia, acts synergistically with exercise in the modulation of muscle protein synthesis. In this sense, a recent study demonstrated that supplementation of a blend of collagen and milk proteins is effective in inducing increases in muscle protein synthesis rates in combination or not with exercise. Accordingly, collagen protein supplementation has also been shown to reduce nitrogen excretion and maintain body mass in individuals undergoing caloric restriction and exercise program.

Additionally, increasing collagen peptide intake has been shown to be effective in increasing collagen synthesis and reducing musculoskeletal pain. In fact, there is evidence that collagen peptide supplementation can improve functional properties in patients with chronic ankle instability. Collagen peptides have a low molecular weight and a high proportion of proline and hydroxyproline, making them more resistant to intestinal digestion and conferring a high transport efficiency and absorption speed. Thus, collagen peptides can accumulate in connective tissue, stimulating the synthesis of extracellular matrix in chondrocytes, for example.

Taken together, the evidence suggests that collagen peptide supplementation may be potentially beneficial for improving functionality in different contexts. In this sense, global demographic projections indicate that the oldest population (>55 years old) will increase substantially in the next 50 years, surpassing 2 billion by the year 2050. Aging, which leads to loss of functionality and clinical conditions associated with muscle, bone and cartilage dysfunctions. The search for lifestyle strategies capable of ensuring quality of life and autonomy and preventing chronic diseases in older individuals is of great clinical relevance. Thus, the eventual scientific proof of the efficacy of collagen protein supplementation in this population may constitute a therapeutic alternative of broad social, marketing and clinical interest, with possible extension of benefits to other age groups and groups with other characteristics.

Thus, the present study aims to investigate whether collagen peptide supplementation combined with exercise provides gains in functionality (primary outcome), muscle mass and strength, bone remodeling markers, and quality of life in adult individuals over 55 years of age.

详细描述

Experimental design and ethical considerations

This is a single-center, randomized, double-blind, placebo-controlled, 12-week clinical trial involving adults over 55 years of age. All participants will be informed about the risks and benefits of participating in the study and will sign an Informed Consent Form, approved by the ethics committee.

Selected participants will be randomly allocated into two groups: collagen (COL) or placebo (PLA). Participants will receive a daily dose of 10 g each of collagen peptides or placebo. The supplements will be provided in powder form, accompanied by a standard meter, and a nutritionist who is a member of the team, blindfolded to the participant's allocation, will be responsible for the (monthly) distribution of the supplement and measurement of adherence to the protocol, through diaries containing information on the time of taking the supplement and possible complications, as well as from the receipt and weighing of the remainder in the returned jars each month.

Exercise Training Protocol

The training will be prescribed remotely, being carried out at home for the convenience of the participants. The intervention will last for 12 weeks and will include exercises to develop muscle strength, aerobic capacity, balance, and flexibility . Each session will last approximately 60 minutes. Participants should perform the exercises at home 3 times a week. The entire protocol will be individualized and always accompanied by the same coach. The control and progression of the intensity of the activity will be based on the perception of exertion reported by the participant. To this end, the Borg scale of subjective perception of exertion (RPE) will be used, segmented into: 6-8 (Very easy), 9-10 (Easy), 11-12 (Relatively easy), 13-14 (Slightly tiring), 15-16 (Tiring), 17-18 (Very tiring) and 19-20 (Exhausting).

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At or above 55 years of age.

排除标准

  • use of medications that may alter muscle responses
  • use of dietary supplements such as proteins, amino acids or creatine
  • being on a restrictive diet
  • current engagement in a strength training program
  • chronic diseases such as hypertension, diabetes mellitus, heart disease, uncontrolled hypo- or hyperthyroidism
  • presence of conditions that prevent participation in an exercise program.

结局指标

主要结局

Sit and Stand test

时间窗: Before and 12-weeks of exercise training program

sit and stand test, assessed as maximal number of stands within 30 seconds

Maximal force production

时间窗: Before and 12-weeks of exercise training program

handgrip force, assessed as maximal kg produced.

Get up and go Test

时间窗: Before and 12-weeks of exercise training program

get up and go test, assessed as the total time to walk 20 m distance.

次要结局

  • N-terminal propeptide bone formation marker of type I pro-collagen (P1NP)(Before and 12-weeks of exercise training program)
  • Lean body mass(Before and 12-weeks of exercise training program)
  • Assessment of dietary intake - Protein(Before and 12-weeks of exercise training program)
  • Assessment of dietary intake - Lipids(Before and 12-weeks of exercise training program)
  • Total fat body mass(Before and 12-weeks of exercise training program)
  • carbox-terminal bone resorption marker telopeptide of type I collagen (CTX)(Before and 12-weeks of exercise training program)
  • Quality of Life using the Short Form Healthy Survey(Before and 12-weeks of exercise training program)
  • Assessment of dietary intake - Carbohydrate(Before and 12-weeks of exercise training program)
  • Assessment of dietary intake - Total calories(Before and 12-weeks of exercise training program)
  • Areal mineral density(Before and 12-weeks of exercise training program)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bruno Gualano

Professor

University of Sao Paulo

研究点 (2)

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