Collagen SupplementationNCT06240429
Collagen Peptide Supplementation and Physical Exercise in Older Adults
A study testing Collagen in people with Collagen Supplementation and Physical Exercise Training, run by University of Sao Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Collagen Supplementation, Physical Exercise Training
- What is being tested?
- Collagen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2023to 23 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At or above 55 years of age.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinical Hospital of the School of Medicine, University of Sao Paulo
São Paulo, 05403-000
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Collagen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CollagenDietary supplement
Daily doses of 10 g collagen peptide supplementation
| Study group | Role | What they receive |
|---|---|---|
| Collagen Supplementation | Experimental | Participants will receive a daily dose of 10 g each of collagen peptides Receives: Dietary Supplement: Collagen |
| Placebo | No intervention | Participants will receive a daily dose of 10 g each of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sit and Stand test
sit and stand test, assessed as maximal number of stands within 30 seconds
Measured: 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.
Measured: Before and 12-weeks of exercise training program
Maximal force production
handgrip force, assessed as maximal kg produced.
Measured: Before and 12-weeks of exercise training program
Secondary outcomes (10)
Lean body mass
Lean body mass using dual-energy X-ray absorptiometry (lumbar spine, femur and total body) (DXA
Measured: Before and 12-weeks of exercise training program
carbox-terminal bone resorption marker telopeptide of type I collagen (CTX)
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).
Measured: Before and 12-weeks of exercise training program
N-terminal propeptide bone formation marker of type I pro-collagen (P1NP)
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).
Measured: Before and 12-weeks of exercise training program
Quality of Life using the Short Form Healthy Survey
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).
Measured: Before and 12-weeks of exercise training program
Assessment of dietary intake - Protein
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).
Measured: Before and 12-weeks of exercise training program
Assessment of dietary intake - Carbohydrate
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).
Measured: Before and 12-weeks of exercise training program
Assessment of dietary intake - Lipids
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).
Measured: Before and 12-weeks of exercise training program
Assessment of dietary intake - Total calories
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).
Measured: Before and 12-weeks of exercise training program
Total fat body mass
Total fat body mass) measured using dual-energy X-ray absorptiometry (lumbar spine, femur and total body) (DXA
Measured: Before and 12-weeks of exercise training program
Areal mineral density
Areal mineral density measured using dual-energy X-ray absorptiometry (lumbar spine, femur and total body) (DXA
Measured: Before and 12-weeks of exercise training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Jan 2023
- Primary completion30 Sep 2023
- Study completion23 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Collagen SupplementationStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240429
- Sponsor's protocol ID
- CAAE 52418421.9.0000.0068
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collagen Peptide Supplementation and Physical Exercise in Adults Over 55 Years of Age: A Randomized, Double-blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06240429
- Acronym / sponsor ID
- CAAE 52418421.9.0000.0068
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Collagen Supplementation | Experimental | Dietary Supplement: CollagenParticipants will receive a daily dose of 10 g each of collagen peptides |
| Placebo | No intervention | –Participants will receive a daily dose of 10 g each of placebo |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At or above 55 years of age.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CollagenDaily doses of 10 g collagen peptide supplementation | Dietary supplement | Collagen Supplementation |
Primary outcome
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
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.
Maximal force production
Time frame: Before and 12-weeks of exercise training program
handgrip force, assessed as maximal kg produced.
10 secondary outcomes
Lean body mass
Time frame: 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
N-terminal propeptide bone formation marker of type I pro-collagen (P1NP)
Time frame: 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
Assessment of dietary intake - Protein
Time frame: Before and 12-weeks of exercise training program
Assessment of dietary intake - Carbohydrate
Time frame: Before and 12-weeks of exercise training program
Assessment of dietary intake - Lipids
Time frame: 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 fat body mass
Time frame: Before and 12-weeks of exercise training program
Areal mineral density
Time frame: Before and 12-weeks of exercise training program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen in people with Collagen Supplementation and Physical Exercise Training, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sit and Stand test (time frame: Before and 12-weeks of exercise training program). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.