Collagen Peptide Supplementation and Physical Exercise in Older Adults

NCT06240429 | Completed

• 1 other identifier: CAAE 52418421.9.0000.0068
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Collagen Supplementation; Physical Exercise Training

Outcome Measures

Primary Outcomes (3)

• Sit and Stand test

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

  Before and 12-weeks of exercise training program

• Get up and go Test

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

  Before and 12-weeks of exercise training program

• Maximal force production

  handgrip force, assessed as maximal kg produced.

  Before and 12-weeks of exercise training program

Secondary Outcomes (10)

• Lean 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

• N-terminal propeptide bone formation marker of type I pro-collagen (P1NP)

  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 - Protein

  Before and 12-weeks of exercise training program

Study Arms (2)

Collagen Supplementation

EXPERIMENTAL

Participants will receive a daily dose of 10 g each of collagen peptides

Dietary Supplement: Collagen

Placebo

NO INTERVENTION

Participants will receive a daily dose of 10 g each of placebo

Interventions

Collagen DIETARY_SUPPLEMENT

Daily doses of 10 g collagen peptide supplementation

Collagen Supplementation

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At or above 55 years of age.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Clinical Hospital of the School of Medicine, University of Sao Paulo

São Paulo, 05403-000, Brazil

Location

MeSH Terms

Interventions

Collagen

Intervention Hierarchy (Ancestors)

Biopolymers; Polymers; Macromolecular Substances; Extracellular Matrix Proteins; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a single-center, randomized, double-blind, placebo-controlled, 12-week clinical trial involving adults over 55 years of age. Randomization of the participants will be performed by blocks of 4 participants, which will be randomized with the help of a specific software (www.random.org/sequences/), in a ratio of 1:1.

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 5, 2024
• Study Start: January 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: January 23, 2024
• Last Updated: February 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)