- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06240429
Collagen Peptide Supplementation and Physical Exercise in Older Adults
Collagen Peptide Supplementation and Physical Exercise in Adults Over 55 Years of Age: A Randomized, Double-blind, Placebo-Controlled Clinical Trial
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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).
Participants will be properly instructed about all the procedures that make up the physical training protocol beforehand when they come to the hospital complex to perform the initial evaluations. On the same day, participants will be given a diary, in which they should write down in as much detail as possible the physical activities performed in their day-to-day life, and materials containing supplementary instructions (e.g., a booklet with images and description of the exercises, and videos demonstrating their proper execution). On the days they perform the training protocol, participants should also write down additional information such as the type of exercise, intensity (degree of effort/RPE per set), number of sets completed and repetitions for each exercise performed. In the case of aerobic activities, participants must fill in the total time spent per exercise (e.g., 30 min) and the number of blocks performed (e.g., 2 blocks of 15 min).
A researcher will contact the participants weekly, on pre-scheduled days and times, to check and request information regarding the diary. At these times, the researcher will also be able to check the completed data and request additional information (e.g., adversities, challenges and barriers encountered, doubts, etc.), control the participants' adherence and establish new goals and objectives. Reported adverse events will be documented and investigated by the research team in order to monitor any risk related to the intervention.
Statistical analysis
At baseline period, the groups will be compared by independent t-test for all variables. Intra- and between-group differences for the dependent variables will be tested from mixed models for repeated measures, assuming group (placebo and collagen ) and time (before and after 12-weeks of exercise intervention) as fixed factors and subjects as random factors. In case of significant F values, analyses were performed post-hoc with Tukey adjustments. The analyses will be carried out following the principles of intention to treat. All analyses will be conducted using Statistical Analysis System software (Institute Inc., Cary, NC) and the significance level will be set at p < 0.05.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Sao Paulo, Brazil, 05403-000
- Clinical Hospital of the School of Medicine, University of Sao Paulo
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- At or above 55 years of age.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Collagen Supplementation
Participants will receive a daily dose of 10 g each of collagen peptides
|
Daily doses of 10 g collagen peptide supplementation
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No Intervention: Placebo
Participants will receive a daily dose of 10 g each of placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sit and Stand test
Time Frame: Before and 12-weeks of exercise training program
|
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
Time Frame: Before and 12-weeks of exercise training program
|
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
Time Frame: Before and 12-weeks of exercise training program
|
handgrip force, assessed as maximal kg produced.
|
Before and 12-weeks of exercise training program
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lean body mass
Time Frame: Before and 12-weeks of exercise training program
|
Lean body mass using dual-energy X-ray absorptiometry (lumbar spine, femur and total body) (DXA
|
Before and 12-weeks of exercise training program
|
carbox-terminal bone resorption marker telopeptide of type I collagen (CTX)
Time Frame: Before and 12-weeks of exercise training program
|
Serum concentrations of the carbox-terminal bone resorption marker telopeptide of type I collagen (CTX) will be obtained by means of the automated electrochemiluminescence method (E411, Roche Diagnostics®, Mannheim, Germany).
|
Before and 12-weeks of exercise training program
|
N-terminal propeptide bone formation marker of type I pro-collagen (P1NP)
Time Frame: Before and 12-weeks of exercise training program
|
Serum concentrations of N-terminal propeptide bone formation marker of type I pro-collagen (P1NP) will be obtained by means of the automated electrochemiluminescence method (E411, Roche Diagnostics®, Mannheim, Germany).
|
Before and 12-weeks of exercise training program
|
Quality of Life using the Short Form Healthy Survey
Time Frame: Before and 12-weeks of exercise training program
|
Quality of life will be assessed using the Short Form Healthy Survey (SF-36; in portuguese version).
The short-form (SF-36) yields an 8-scale profile of scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health).
Physical component summary (primary outcome) and mental component summary were also calculated.
Scores range from 0 to 100 (higher scores indicate better health quality of life).
|
Before and 12-weeks of exercise training program
|
Assessment of dietary intake - Protein
Time Frame: Before and 12-weeks of exercise training program
|
Protein intake (total, in g; relative, in % of total energy value; relative to body weight, in g/kg/day), will be assessed before and after the intervention by means of three food diaries on non-consecutive days (including two days of the week and one day of the weekend).
|
Before and 12-weeks of exercise training program
|
Assessment of dietary intake - Carbohydrate
Time Frame: Before and 12-weeks of exercise training program
|
Carbohydrates in the diet (total, in g; relative, in % of total energy value) will be assessed before and after the intervention by means of three food diaries on non-consecutive days (including two days of the week and one day of the weekend).
|
Before and 12-weeks of exercise training program
|
Assessment of dietary intake - Lipids
Time Frame: Before and 12-weeks of exercise training program
|
Lipids in the diet (total, in g; relative, in % of total energy value) will be assessed before and after the intervention by means of three food diaries on non-consecutive days (including two days of the week and one day of the weekend).
|
Before and 12-weeks of exercise training program
|
Assessment of dietary intake - Total calories
Time Frame: Before and 12-weeks of exercise training program
|
Total calories (in kcal units) will be assessed before and after the intervention by means of three food diaries on non-consecutive days (including two days of the week and one day of the weekend).
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Before and 12-weeks of exercise training program
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Total fat body mass
Time Frame: Before and 12-weeks of exercise training program
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Total fat body mass) measured using dual-energy X-ray absorptiometry (lumbar spine, femur and total body) (DXA
|
Before and 12-weeks of exercise training program
|
Areal mineral density
Time Frame: Before and 12-weeks of exercise training program
|
Areal mineral density measured using dual-energy X-ray absorptiometry (lumbar spine, femur and total body) (DXA
|
Before and 12-weeks of exercise training program
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CAAE 52418421.9.0000.0068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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