Diet, Food, and NutritionNCT05932771

Resistance Exercise and Hydrolyzed Collagen Supplementation

A study testing Experimental: Consumption of three different doses of hydrolyzed collagen (HC) with reistance exercise and Experimental: Consumption of two different doses of hydrolyzed collagen (HC) with reistance exercise in people with Diet, Food, and Nutrition, run by Rob Erskine at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 healthy young and older males and females. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Diet, Food, and Nutrition
What is being tested?: Experimental: Consumption of three different doses of hydrolyzed collagen (HC) with reistance exercise and Experimental: 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: 21 participants
Where: 1 siteUnited Kingdom
Study dates: 1 Jan 2019to 30 Apr 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 18 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 (regular back squat experience)
Free from musculoskeletal injury
Nullipara (a woman who has never given birth) (only for young female participatns)

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
<18 or >40 years old (only for young participants)
<40 ro >65 years old (only for older participants)
Having an irregular menstrual cycle (only for young female participants)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Dr Rob Erskine
Liverpool, L3 3AF

Other trials in United Kingdom

About this study

Official title: The Dose-response of Vitamin C-enriched Collagen on Markers of Collagen Synthesis in Healthy Young and Older 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 healthy young and older 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 young and older males and females.

Healthy young and older males and females ingested 0 grams, 15 grams or 30 grams HC with 50 milligrams vitamin C 1h prior to performing four sets' barbell back-squat 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 healthy young and older 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.

Conditions: Diet, Food, and Nutrition
Being tested: Experimental: Consumption of three different doses of hydrolyzed collagen (HC) with reistance exercise, Experimental: Consumption of two different doses of hydrolyzed collagen (HC) with reistance exercise
Keywords: Hydolyzed 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.

Experimental: Consumption of three different doses of hydrolyzed collagen (HC) with reistance exerciseDietary supplement
Also called Resistance exercise and collagen dose-response for male participants
Each trial 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 trials 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 nutritoinal 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)
Experimental: Consumption of two different doses of hydrolyzed collagen (HC) with reistance exerciseDietary supplement
Also called Resistance exercise and collagen dose-response for female participants
Each trial 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 trials 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 maltodextrin was used in 0 grams HC. Also to mask any potential difference in HC doses, 4 grams non-caloric sweetener was used in all HC doses.
The details of nutritoinal 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 groups in NCT05932771
Study group	Role	What they receive
1.Trial for young male participants: Consuming hydrolyzed collagen (HC) with reistance exercise	Experimental	Young male participants consumed one of three different HC doses (0 grams, 15 grams, or 30 grams) with 4 sets of 10 repetitions of barbell back squat exercise at 10-repetition maximum load in a random order and a seven-day wash-out period interspersed between each trial. Receives: Dietary Supplement: Experimental: Consumption of three different doses of hydrolyzed collagen (HC) with reistance exercise
2.Trial for young female participant: Consuming hydrolyzed collagen (HC) with reistance exercise	Experimental	The intervention procedure is exactly same as Arm 1 except for the number of visits. Young female participant was asked to visit the laboratory on four occasions during two consecutive months. Therefore, there were two trials in each month, where female participants' estrogen level was lower (i.e., onset of menses) or higher (i.e., ovulation). Dates for the trials were determined based on self-report of onset of menses and previous menstrual cycle length. Receives: Dietary Supplement: Experimental: Consumption of two different doses of hydrolyzed collagen (HC) with reistance exercise
3.Trial for older male participants: Consuming hydrolyzed collagen (HC) with reistance exercise	Experimental	The age range of older male participants was 40 - 65 years. The intervention procedure is exactly same as Arm 1 Receives: Dietary Supplement: Experimental: Consumption of three different doses of hydrolyzed collagen (HC) with reistance exercise
4.Trial for older female participants: Consuming hydrolyzed collagen (HC) with reistance exercise	Experimental	The age range of older female participants was 40 - 65 years. The intervention procedure is exactly same as Arm 2 Receives: Dietary Supplement: Experimental: 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 resistnace exercise (RE) during all trials.
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 resistnace exercise (RE) during all trials.
Measured: at rest immediately prior to HC ingestion and 6-hour post RE
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 resistnace exercise (RE) during all trials.
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

Secondary outcomes (1)

Estrogen concentrations in women in each trial
Concentrations of estrogen (17β-estradiol) was measured in each trial.
Measured: at rest immediately prior to HC ingestion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201930 Apr 2023

First posted6 Jul 2023
Study start1 Jan 2019
Primary completion30 Aug 2019
Study completion30 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diet, Food, and NutritionStudies 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: A double-blind, randomised cross-over design
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05932771
Sponsor's protocol ID: 18/SPS/059
Status last verified: Jun 2023
First submitted: 26 May 2023
Last updated: 6 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No plan to share

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2023. 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 Healthy Young and Older Men and Women Following Resistance Exercise
ClinicalTrials.gov ID: NCT05932771
Acronym / sponsor ID: 18/SPS/059
Conditions: Diet, Food, and Nutrition
Keywords: Hydolyzed collagen, Resistance exercise, Collagen synthesis, Proline, Glycine
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Rob ErskineUniversity, hospital or other
Collaborators: University of East Anglia
Study start: 1 Jan 2019 (actual)
Primary completion: 30 Aug 2019 (actual)
Study completion: 30 Apr 2023 (actual)
First posted: 6 Jul 2023 (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 healthy young and older 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 young and older males and females.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4
Model description: A double-blind, randomised cross-over design

Arm	Type	Receives
1.Trial for young male participants: Consuming hydrolyzed collagen (HC) with reistance exercise	Experimental	Dietary Supplement: Experimental: Consumption of three different doses of hydrolyzed collagen (HC) with reistance exerciseYoung male participants consumed one of three different HC doses (0 grams, 15 grams, or 30 grams) with 4 sets of 10 repetitions of barbell back squat exercise at 10-repetition maximum load in a random order and a seven-day wash-out period interspersed between each trial.
2.Trial for young female participant: Consuming hydrolyzed collagen (HC) with reistance exercise	Experimental	Dietary Supplement: Experimental: 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. Young female participant was asked to visit the laboratory on four occasions during two consecutive months. Therefore, there were two trials in each month, where female participants' estrogen level was lower (i.e., onset of menses) or higher (i.e., ovulation). Dates for the trials were determined based on self-report of onset of menses and previous menstrual cycle length.
3.Trial for older male participants: Consuming hydrolyzed collagen (HC) with reistance exercise	Experimental	Dietary Supplement: Experimental: Consumption of three different doses of hydrolyzed collagen (HC) with reistance exerciseThe age range of older male participants was 40 - 65 years. The intervention procedure is exactly same as Arm 1
4.Trial for older female participants: Consuming hydrolyzed collagen (HC) with reistance exercise	Experimental	Dietary Supplement: Experimental: Consumption of two different doses of hydrolyzed collagen (HC) with reistance exerciseThe age range of older female participants was 40 - 65 years. The intervention procedure is exactly same as Arm 2

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

At least 12 months experienced in resistance exercise (regular back squat experience)
Free from musculoskeletal injury
Nullipara (a woman who has never given birth) (only for young female participatns)

Key exclusion criteria (8 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
Experimental: Consumption of three different doses of hydrolyzed collagen (HC) with reistance exerciseAlso: Resistance exercise and collagen dose-response for male participantsEach trial 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 trials 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 nutritoinal 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	1.Trial for young male participants: Consuming hydrolyzed collagen (HC) with reistance exercise, 3.Trial for older male participants: Consuming hydrolyzed collagen (HC) with reistance exercise
Experimental: Consumption of two different doses of hydrolyzed collagen (HC) with reistance exerciseAlso: Resistance exercise and collagen dose-response for female participantsEach trial 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 trials 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 maltodextrin was used in 0 grams HC. Also to mask any potential difference in HC doses, 4 grams non-caloric sweetener was used in all HC doses. The details of nutritoinal 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	2.Trial for young female participant: Consuming hydrolyzed collagen (HC) with reistance exercise, 4.Trial for older female participants: Consuming hydrolyzed collagen (HC) with reistance 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 resistnace exercise (RE) during all trials.
Change in a marker of collagen breakdown
Time frame: at rest immediately prior to HC ingestion 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 resistnace exercise (RE) during all trials.
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
Concentration of serum amino acids that constitute collagen was measured following 0 grams, 15 grams or 30 grams hydrolyzed collagen (HC) intake with resistnace exercise (RE) during all trials.

1 secondary outcome

Estrogen concentrations in women in each trial
Time frame: at rest immediately prior to HC ingestion

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 6 Jul 2023.
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, PhD study director

Liverpool John Moores University

Joonsung Lee, MSc principal investigator

Liverpool John Moores University

Christopher Nulty 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?

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 3 inclusion and 8 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 6 Jul 2023. 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 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?

On the ClinicalTrials.gov record for NCT05932771.

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 6 Jul 2023.