DietNCT06236659
Acute Resistance Exercise and Hydrolyzed Collagen Supplementation
A study testing Consumption of three different doses of hydrolyzed collagen (HC) with resistance exercise and Consumption of two different doses of hydrolyzed collagen (HC) with reistance exercise in people with Diet and Food, run by Rob Erskine at 1 site in United Kingdom.
Trial summary
This study aimed to investigate the effect of different doses of hydrolyzed collagen (HC) with resistance exercise (RE) on whole body collagen synthesis in middle-aged males and females. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Consumption of three different doses of hydrolyzed collagen (HC) with resistance exercise and Consumption of two different doses of hydrolyzed collagen (HC) with reistance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2019to 30 Sep 2023
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 12 months experienced in resistance exercise (including weekly lower body exercise)
- Free from musculoskeletal injury
Who cannot join
- Having a history of patellar tendon pathology
- Vegan
- Consumed nutritional supplements or medication purported to have beneficial effects on muscle-tendon properties (e.g. antioxidants, protein, etc.)
- Had a sustained a lower limb injury in the previous six months
- Smoker/vaper
- Having reached menopause (only for middle-aged female participants)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Dose-response of Vitamin C-enriched Collagen on Markers of Collagen Synthesis in Middle-Aged Men and Women Following Resistance Exercise
This study aimed to investigate the effect of different doses of hydrolyzed collagen (HC) with resistance exercise (RE) on whole body collagen synthesis in middle-aged males and females.
Read the detailed description
This study aimed to investigate the effect of different doses of hydrolyzed collagen (HC) with resistance exercise (RE) on whole body collagen synthesis in healthy middle-aged males and females.
Healthy middle-aged males and females ingested 0 grams, 15 grams or 30 grams HC with 50 milligrams vitamin C 1h prior to performing four sets' leg press RE at 10-repetition maximum load, after which they rested for six hours. Blood samples were collected throughout each trial to analyse procollagen type Ⅰ N-terminal propeptide (PⅠNP, a biomarker of collagen synthesis) and β-isomerized C-terminal telopeptide of type I collagen (β-CTX, a biomarker of collagen breakdown) concentration, and the concentration of 18 amino acids that constitute collagen.
This is the first study to investigate the combined effect of different doses HC with high-intensity RE on whole body collagen synthesis in middle-aged men and women. If 30 grams HC intake with RE does augment collagen synthesis more than RE alone, this suggests that long-term HC intake with chronic RE would be beneficial for tendon health, because collagen is the most abundant protein in tendon.
- Being tested
- Consumption of three different doses of hydrolyzed collagen (HC) with resistance exercise, Consumption of two different doses of hydrolyzed collagen (HC) with reistance exercise
- Keywords
- Hydrolyzed collagen, Resistance Exercise, Collagen Synthesis, Proline, Glycine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consumption of three different doses of hydrolyzed collagen (HC) with resistance exerciseDietary supplement
Also called Resistance exercise and collagen dose-response for middle-aged male participants
Each intervention lasts for seven hours and while participants consumed HC, performed resistance exercise and rested, 10 x 5 mL blood samples were collected from a superficial forearm vein using a cannula.
All interventions were performed at the same time of day (08:00 - 15:00).
Different doses of HC (0 grams, 15 grams and 30 grams) and 50 milligrams vitamin C were dissolved with 250 milliliter water in an opaque bottle. To match calories of 30 grams HC, 34.1 grams and 15.4 grams maltodextrin was used in 0 grams HC and 15 grams HC respectively. Also to mask any potential difference in HC doses, 4 grams non-caloric sweetener was used in all HC doses.
The details of dietary supplements used are as follows:
Hydrolysed collagen (Myprotein, Cheshire, UK), Vitamin C powder (Holland and Barrett Retail Limited, Warwickshire, UK), Maltodextrin (Myprotein, Cheshire, UK), and Non-caloric sweetener (Truvia®, SilverSpoon, London, UK)
Consumption of two different doses of hydrolyzed collagen (HC) with reistance exerciseDietary supplement
Also called Resistance exercise and collagen dose-response for middle-aged female participants
Each intervention lasts for seven hours and while participants consumed HC, performed resistance exercise and rested, 10 x 5 mL blood samples were collected from a superficial forearm vein using a cannula.
All interventions were performed at the same time of day (08:00 - 15:00).
Different doses of HC (0 grams, and 30 grams) and 50 milligrams vitamin C were dissolved with 250 milliliter water in an opaque bottle. To match calories of 30 grams HC, 34.1 grams and 15.4 grams maltodextrin was used in 0 grams HC and 15 grams HC respectively. Also to mask any potential difference in HC doses, 4 grams non-caloric sweetener was used in all HC doses.
The details of dietary supplements used are as follows:
Hydrolysed collagen (Myprotein, Cheshire, UK), Vitamin C powder (Holland and Barrett Retail Limited, Warwickshire, UK), Maltodextrin (Myprotein, Cheshire, UK), and Non-caloric sweetener (Truvia®, SilverSpoon, London, UK)
| Study group | Role | What they receive |
|---|---|---|
| Intervention for middle-aged men: Consumption of hydrolyzed collagen (HC) with resistance exercise | Experimental | Middle-aged male participants consumed one of three different HC doses (0 grams, 15 grams, or 30 grams) with 4 sets of 10 repetitions of leg press exercise at 10-repetition maximum load in a random order and a seven-day wash-out period interspersed between each trial. Receives: Dietary Supplement: Consumption of three different doses of hydrolyzed collagen (HC) with resistance exercise |
| Intervention for middle-aged women: Consumption of hydrolyzed collagen (HC) with resistance exercise | Experimental | The intervention procedure is exactly same as Arm 1 except for the number of visits and doses of HC. Middle-aged female participants were asked to visit the laboratory on the day of highest oestrogen (i.e. ovulation) and provided with 0 g or 30 g HC. Dates for the trials were determined based on self-report of onset of menses and previous menstrual cycle length. Receives: Dietary Supplement: Consumption of two different doses of hydrolyzed collagen (HC) with reistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in a marker of collagen synthesis
Serum procollagen type Ⅰ N-terminal propeptide (PⅠNP) concentrations were measured following 0 grams, 15 grams or 30 grams hydrolyzed collagen (HC) intake with resistance exercise (RE) during all interventions.
Measured: At rest immediately prior to HC ingestion, 0.5-hour post RE, 1-hour post RE, 2-hour post RE, 4-hour post RE and 6-hour post RE
Change in a marker of collagen breakdown
Plasma β-isomerized C-terminal telopeptide of type I collagen (β-CTX) concentrations were measured following 0 grams, 15 grams or 30 grams hydrolyzed collagen (HC) intake with resistance exercise (RE) during all interventions.
Measured: At rest, immediately prior to HC ingestion, 0.5-hour post RE, 2-hour post RE and 6-hour post RE
Secondary outcomes (2)
Estrogen concentrations in women in each trial
Concentrations of estrogen (17β-estradiol) was measured in each intervention.
Measured: At rest immediately prior to HC ingestion
Changes in amino acids concentrations in blood
Concentration of serum amino acids that constitute collagen was measured following 0 grams, 15 grams or 30 grams hydrolyzed collagen (HC) intake with resistance exercise (RE) during all interventions.
Measured: At rest immediately prior to HC ingestion, 0.5-hour post HC ingestion, 1-hour post HC ingestion, 0.5-hour post RE, 1-hour post RE, 2-hour post RE, 4-hour post RE and 6-hour post RE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Dec 2019
- Primary completion30 Sep 2021
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DietStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, randomized cross-over design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rob Erskine
- Sponsor type
- University, hospital or other
- Collaborators
- University of East Anglia
- Responsible party
- Sponsor-investigator, Rob Erskine, Liverpool John Moores University
- Investigators
- Robert M Erskine, Principal investigator, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236659
- Sponsor's protocol ID
- 19/SPS/049
- Status last verified
- Jan 2024
- First submitted
- 24 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dose-response of Vitamin C-enriched Collagen on Markers of Collagen Synthesis in Middle-Aged Men and Women Following Resistance Exercise
- ClinicalTrials.gov ID
- NCT06236659
- Acronym / sponsor ID
- 19/SPS/049
- Keywords
- Hydrolyzed collagen, Resistance Exercise, Collagen Synthesis, Proline, Glycine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rob ErskineUniversity, hospital or other
- Collaborators
- University of East Anglia
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 1 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.
This study aimed to investigate the effect of different doses of hydrolyzed collagen (HC) with resistance exercise (RE) on whole body collagen synthesis in middle-aged males and females.
Detailed description
This study aimed to investigate the effect of different doses of hydrolyzed collagen (HC) with resistance exercise (RE) on whole body collagen synthesis in healthy middle-aged males and females.
Healthy middle-aged males and females ingested 0 grams, 15 grams or 30 grams HC with 50 milligrams vitamin C 1h prior to performing four sets' leg press RE at 10-repetition maximum load, after which they rested for six hours. Blood samples were collected throughout each trial to analyse procollagen type Ⅰ N-terminal propeptide (PⅠNP, a biomarker of collagen synthesis) and β-isomerized C-terminal telopeptide of type I collagen (β-CTX, a biomarker of collagen breakdown) concentration, and the concentration of 18 amino acids that constitute collagen.
This is the first study to investigate the combined effect of different doses HC with high-intensity RE on whole body collagen synthesis in middle-aged men and women. If 30 grams HC intake with RE does augment collagen synthesis more than RE alone, this suggests that long-term HC intake with chronic RE would be beneficial for tendon health, because collagen is the most abundant protein in tendon.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomized cross-over design
| Arm | Type | Receives |
|---|---|---|
| Intervention for middle-aged men: Consumption of hydrolyzed collagen (HC) with resistance exercise | Experimental | Dietary Supplement: Consumption of three different doses of hydrolyzed collagen (HC) with resistance exerciseMiddle-aged male participants consumed one of three different HC doses (0 grams, 15 grams, or 30 grams) with 4 sets of 10 repetitions of leg press exercise at 10-repetition maximum load in a random order and a seven-day wash-out period interspersed between each trial. |
| Intervention for middle-aged women: Consumption of hydrolyzed collagen (HC) with resistance exercise | Experimental | Dietary Supplement: Consumption of two different doses of hydrolyzed collagen (HC) with reistance exerciseThe intervention procedure is exactly same as Arm 1 except for the number of visits and doses of HC. Middle-aged female participants were asked to visit the laboratory on the day of highest oestrogen (i.e. ovulation) and provided with 0 g or 30 g HC. Dates for the trials were determined based on self-report of onset of menses and previous menstrual cycle length. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 12 months experienced in resistance exercise (including weekly lower body exercise)
- Free from musculoskeletal injury
Key exclusion criteria (6 listed)
- Having a history of patellar tendon pathology
- Vegan
- Consumed nutritional supplements or medication purported to have beneficial effects on muscle-tendon properties (e.g. antioxidants, protein, etc.)
- Had a sustained a lower limb injury in the previous six months
- Smoker/vaper
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 |
|---|---|---|
| Consumption of three different doses of hydrolyzed collagen (HC) with resistance exerciseAlso: Resistance exercise and collagen dose-response for middle-aged male participantsEach intervention lasts for seven hours and while participants consumed HC, performed resistance exercise and rested, 10 x 5 mL blood samples were collected from a superficial forearm vein using a cannula. All interventions were performed at the same time of day (08:00 - 15:00). Different doses of HC (0 grams, 15 grams and 30 grams) and 50 milligrams vitamin C were dissolved with 250 milliliter water in an opaque bottle. To match calories of 30 grams HC, 34.1 grams and 15.4 grams maltodextrin was used in 0 grams HC and 15 grams HC respectively. Also to mask any potential difference in HC doses, 4 grams non-caloric sweetener was used in all HC doses. The details of dietary supplements used are as follows: Hydrolysed collagen (Myprotein, Cheshire, UK), Vitamin C powder (Holland and Barrett Retail Limited, Warwickshire, UK), Maltodextrin (Myprotein, Cheshire, UK), and Non-caloric sweetener (Truvia®, SilverSpoon, London, UK) | Dietary supplement | Intervention for middle-aged men: Consumption of hydrolyzed collagen (HC) with resistance exercise |
| Consumption of two different doses of hydrolyzed collagen (HC) with reistance exerciseAlso: Resistance exercise and collagen dose-response for middle-aged female participantsEach intervention lasts for seven hours and while participants consumed HC, performed resistance exercise and rested, 10 x 5 mL blood samples were collected from a superficial forearm vein using a cannula. All interventions were performed at the same time of day (08:00 - 15:00). Different doses of HC (0 grams, and 30 grams) and 50 milligrams vitamin C were dissolved with 250 milliliter water in an opaque bottle. To match calories of 30 grams HC, 34.1 grams and 15.4 grams maltodextrin was used in 0 grams HC and 15 grams HC respectively. Also to mask any potential difference in HC doses, 4 grams non-caloric sweetener was used in all HC doses. The details of dietary supplements used are as follows: Hydrolysed collagen (Myprotein, Cheshire, UK), Vitamin C powder (Holland and Barrett Retail Limited, Warwickshire, UK), Maltodextrin (Myprotein, Cheshire, UK), and Non-caloric sweetener (Truvia®, SilverSpoon, London, UK) | Dietary supplement | Intervention for middle-aged women: Consumption of hydrolyzed collagen (HC) with resistance exercise |
Primary outcome
Change in a marker of collagen synthesis
Time frame: At rest immediately prior to HC ingestion, 0.5-hour post RE, 1-hour post RE, 2-hour post RE, 4-hour post RE and 6-hour post RE
Serum procollagen type Ⅰ N-terminal propeptide (PⅠNP) concentrations were measured following 0 grams, 15 grams or 30 grams hydrolyzed collagen (HC) intake with resistance exercise (RE) during all interventions.
Change in a marker of collagen breakdown
Time frame: At rest, immediately prior to HC ingestion, 0.5-hour post RE, 2-hour post RE and 6-hour post RE
Plasma β-isomerized C-terminal telopeptide of type I collagen (β-CTX) concentrations were measured following 0 grams, 15 grams or 30 grams hydrolyzed collagen (HC) intake with resistance exercise (RE) during all interventions.
2 secondary outcomes
Estrogen concentrations in women in each trial
Time frame: At rest immediately prior to HC ingestion
Changes in amino acids concentrations in blood
Time frame: At rest immediately prior to HC ingestion, 0.5-hour post HC ingestion, 1-hour post HC ingestion, 0.5-hour post RE, 1-hour post RE, 2-hour post RE, 4-hour post RE and 6-hour post RE
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 2 Feb 2024.
- Individual participant dataSharing planned: No. No plan to share
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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.
Robert M Erskine principal investigator
Liverpool John Moores University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consumption of three different doses of hydrolyzed collagen (HC) with resistance exercise and Consumption of two different doses of hydrolyzed collagen (HC) with reistance exercise in people with Diet and Food, run by Rob Erskine at 1 site in United Kingdom.
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 2 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 2 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 United Kingdom. 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?
Change in a marker of collagen synthesis (time frame: At rest immediately prior to HC ingestion, 0.5-hour post RE, 1-hour post RE, 2-hour post RE, 4-hour post RE and 6-hour post RE). The study lists 2 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 2 Feb 2024.