Exercise Induced Muscle DamageNCT05346211
The Effect of Curcumin Supplementation on Recovery From Exercise-induced Muscle Damage
A study testing Curcumin in people with Exercise Induced Muscle Damage, run by St Mary's University College.
Trial summary
Recent evidence suggests that curcumin supplementation may reduce muscle inflammation, oxidative markers, and muscle damage. The most favourable dosage to elicit these ergogenic effects are yet to be established; both 750mg \& 1500mg has been shown to be effective. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Induced Muscle Damage
- What is being tested?
- Curcumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- between the age of 18-35
- non-smoker
- no previous history of cardiovascular, respiratory, or neurological problems
- not taking anticoagulant medication
- injury-free in the 3 months prior to scheduled participation in the study
Who cannot join
- hypertension (<140/80)
- any blood diseases or clotting issues,
- injury, or previous injury in <3 months
Trial locations and contacts
No sites are listed yet.
About this study
Recent evidence suggests that curcumin supplementation may reduce muscle inflammation, oxidative markers, and muscle damage. The most favourable dosage to elicit these ergogenic effects are yet to be established; both 750mg \& 1500mg has been shown to be effective. Curcumin supplementation has been ingested in numerous different ways however, no previous research to date has used curcumin in a hydrolysed (drinkable) format. The aim of this study is to investigate whether hydrolysed curcumin can reduce indices of muscle damage and improve recovery, whilst also examining a potential dose-response effect.
- Conditions
- Exercise Induced Muscle Damage
- Being tested
- Curcumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
Curcumin Supplementation
| Study group | Role | What they receive |
|---|---|---|
| Curcumin Single | Experimental | The Single dose group will consume 1 placebo sachet and one curcumin sachet per day.
Curcumin supplementation will be from YourZooki, the supplement in question is commercially offered to the public in a tangerine flavour. The sachets will be in 750mg hydrolysed format.
The placebo is a sachet containing the same ingredients mentioned above minus the curcumin. The sachets will be in 750mg hydrolysed format.
Supplementation will be administered and commence 48-hours prior to the first testing day and will be consumed twice a day (8am \& 8pm). Receives: Dietary Supplement: Curcumin |
| Curcumin Double | Experimental | The double dose group will consume two sachets per day of curcumin.
Curcumin supplementation will be from YourZooki, the supplement in question is commercially offered to the public in a tangerine flavour. The sachets will be in 750mg hydrolysed format.
Supplementation will be administered and commence 48-hours prior to the first testing day and will be consumed twice a day (8am \& 8pm). Receives: Dietary Supplement: Curcumin |
| Placebo | No intervention | Placebo sachets containing the same ingredients mentioned above minus the curcumin. The sachets will be in 750mg hydrolysed format. Participants will consume two sachets per day. Supplementation will be administered and commence 48-hours prior to the first testing day and will be consumed twice a day (8am \& 8pm). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood markers
Blood samples will be taken for analysis of markers of IL-6, IL-1β, TNF-α, IL-1, IL-4, IL-10 and CK will be taken
Measured: Baseline
Blood markers
Blood samples will be taken for analysis of markers of IL-6, IL-1β, TNF-α, IL-1, IL-4, IL-10 and CK will be taken
Measured: immediately post muscle damage intervention
Blood markers
Blood samples will be taken for analysis of markers of IL-6, IL-1β, TNF-α, IL-1, IL-4, IL-10 and CK will be taken
Measured: 24 hours post
Blood markers
Blood samples will be taken for analysis of markers of IL-6, IL-1β, TNF-α, IL-1, IL-4, IL-10 and CK will be taken
Measured: 48 hours post
Blood markers
Blood samples will be taken for analysis of markers of IL-6, IL-1β, TNF-α, IL-1, IL-4, IL-10 and CK will be taken
Measured: 72 hours post
Ford and Fort
Capillary sample Ford and Fort tests
Measured: Baseline
Ford and Fort
Capillary sample Ford and Fort tests
Measured: Immediately post muscle damage intervention
Ford and Fort
Capillary sample Ford and Fort tests
Measured: 24 hours post
Ford and Fort
Capillary sample Ford and Fort tests
Measured: 48 hours post
Ford and Fort
Capillary sample Ford and Fort tests
Measured: 72 hours post
Soreness
Perceived muscle soreness scale - Visual analouge scale
Measured: Baseline
Soreness
Perceived muscle soreness scale - Visual analouge scale
Measured: Immediately post muscle damage intervention
Soreness
Perceived muscle soreness scale - Visual analouge scale
Measured: 24 hours post
Soreness
Perceived muscle soreness scale - Visual analouge scale
Measured: 48 hours post
Soreness
Perceived muscle soreness scale - Visual analouge scale
Measured: 72 hours post
Soreness
BORG CR-10 scale
Measured: Baseline
Soreness
BORG CR-10 scale
Measured: Immediately post muscle damage intervention
Soreness
BORG CR-10 scale
Measured: 24 hours post
Soreness
BORG CR-10 scale
Measured: 48 hours post
Soreness
BORG CR-10 scale
Measured: 72 hours post
Soreness
Pressure pain threshold
Measured: Baseline
Soreness
Pressure pain threshold
Measured: Immediately post muscle damage intervention
Soreness
Pressure pain threshold
Measured: 24 hours post
Soreness
Pressure pain threshold
Measured: 48 hours post
Soreness
Pressure pain threshold
Measured: 72 hours post
Muscle Structure
Muscle swelling - thigh girth + Ultrasound measurement
Measured: Baseline
Muscle Structure
Muscle swelling - thigh girth + Ultrasound measurement
Measured: Immediately post muscle damage intervention
Muscle Structure
Muscle swelling - thigh girth + Ultrasound measurement
Measured: 24 hours post
Muscle Structure
Muscle swelling - thigh girth + Ultrasound measurement
Measured: 48 hours post
Muscle Structure
Muscle swelling - thigh girth + Ultrasound measurement
Measured: 72 hours post
Muscle Function
maximal strength
Measured: Baseline
Muscle Function
maximal strength
Measured: Immediately post muscle damage intervention
Muscle Function
maximal strength
Measured: 24 hours post
Muscle Function
maximal strength
Measured: 48 hours post
Muscle Function
maximal strength
Measured: 72 hours post
Muscle Function
Muscular endurance
Measured: Baseline
Muscle Function
Muscular endurance
Measured: Immediately post muscle damage intervention
Muscle Function
Muscular endurance
Measured: 24 hours post
Muscle Function
Muscular endurance
Measured: 48 hours post
Muscle Function
Muscular endurance
Measured: 72 hours post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise Induced Muscle DamageStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Mary's University College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luke Hughes, PhD, Principal investigator, Northumbria UniversityJess Hill, PhD, Principal investigator, St. Mary's University, Twickenham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346211
- Sponsor's protocol ID
- ASE22HELCON
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- 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 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Curcumin Supplementation on Recovery From Exercise-induced Muscle Damage
- ClinicalTrials.gov ID
- NCT05346211
- Acronym / sponsor ID
- ASE22HELCON
- Conditions
- Exercise Induced Muscle Damage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- St Mary's University CollegeUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 26 Apr 2022 (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.
Recent evidence suggests that curcumin supplementation may reduce muscle inflammation, oxidative markers, and muscle damage. The most favourable dosage to elicit these ergogenic effects are yet to be established; both 750mg \& 1500mg has been shown to be effective. Curcumin supplementation has been ingested in numerous different ways however, no previous research to date has used curcumin in a hydrolysed (drinkable) format. The aim of this study is to investigate whether hydrolysed curcumin can reduce indices of muscle damage and improve recovery, whilst also examining a potential dose-response effect.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Curcumin Single | Experimental | Dietary Supplement: CurcuminThe Single dose group will consume 1 placebo sachet and one curcumin sachet per day. Curcumin supplementation will be from YourZooki, the supplement in question is commercially offered to the public in a tangerine flavour. The sachets will be in 750mg hydrolysed format. The placebo is a sachet containing the same ingredients mentioned above minus the curcumin. The sachets will be in 750mg hydrolysed format. Supplementation will be administered and commence 48-hours prior to the first testing day and will be consumed twice a day (8am \& 8pm). |
| Curcumin Double | Experimental | Dietary Supplement: CurcuminThe double dose group will consume two sachets per day of curcumin. Curcumin supplementation will be from YourZooki, the supplement in question is commercially offered to the public in a tangerine flavour. The sachets will be in 750mg hydrolysed format. Supplementation will be administered and commence 48-hours prior to the first testing day and will be consumed twice a day (8am \& 8pm). |
| Placebo | No intervention | –Placebo sachets containing the same ingredients mentioned above minus the curcumin. The sachets will be in 750mg hydrolysed format. Participants will consume two sachets per day. Supplementation will be administered and commence 48-hours prior to the first testing day and will be consumed twice a day (8am \& 8pm). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- between the age of 18-35
- non-smoker
- no previous history of cardiovascular, respiratory, or neurological problems
- not taking anticoagulant medication
- injury-free in the 3 months prior to scheduled participation in the study
Key exclusion criteria (3 listed)
- hypertension (<140/80)
- any blood diseases or clotting issues,
- injury, or previous injury in <3 months
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 |
|---|---|---|
| CurcuminCurcumin Supplementation | Dietary supplement | Curcumin Double, Curcumin Single |
Primary outcome
Blood markers
Time frame: Baseline
Blood samples will be taken for analysis of markers of IL-6, IL-1β, TNF-α, IL-1, IL-4, IL-10 and CK will be taken
Blood markers
Time frame: immediately post muscle damage intervention
Blood samples will be taken for analysis of markers of IL-6, IL-1β, TNF-α, IL-1, IL-4, IL-10 and CK will be taken
Blood markers
Time frame: 24 hours post
Blood samples will be taken for analysis of markers of IL-6, IL-1β, TNF-α, IL-1, IL-4, IL-10 and CK will be taken
Blood markers
Time frame: 48 hours post
Blood samples will be taken for analysis of markers of IL-6, IL-1β, TNF-α, IL-1, IL-4, IL-10 and CK will be taken
Blood markers
Time frame: 72 hours post
Blood samples will be taken for analysis of markers of IL-6, IL-1β, TNF-α, IL-1, IL-4, IL-10 and CK will be taken
Ford and Fort
Time frame: Baseline
Capillary sample Ford and Fort tests
Ford and Fort
Time frame: Immediately post muscle damage intervention
Capillary sample Ford and Fort tests
Ford and Fort
Time frame: 24 hours post
Capillary sample Ford and Fort tests
Ford and Fort
Time frame: 48 hours post
Capillary sample Ford and Fort tests
Ford and Fort
Time frame: 72 hours post
Capillary sample Ford and Fort tests
Soreness
Time frame: Baseline
Perceived muscle soreness scale - Visual analouge scale
Soreness
Time frame: Immediately post muscle damage intervention
Perceived muscle soreness scale - Visual analouge scale
Soreness
Time frame: 24 hours post
Perceived muscle soreness scale - Visual analouge scale
Soreness
Time frame: 48 hours post
Perceived muscle soreness scale - Visual analouge scale
Soreness
Time frame: 72 hours post
Perceived muscle soreness scale - Visual analouge scale
Soreness
Time frame: Baseline
BORG CR-10 scale
Soreness
Time frame: Immediately post muscle damage intervention
BORG CR-10 scale
Soreness
Time frame: 24 hours post
BORG CR-10 scale
Soreness
Time frame: 48 hours post
BORG CR-10 scale
Soreness
Time frame: 72 hours post
BORG CR-10 scale
Soreness
Time frame: Baseline
Pressure pain threshold
Soreness
Time frame: Immediately post muscle damage intervention
Pressure pain threshold
Soreness
Time frame: 24 hours post
Pressure pain threshold
Soreness
Time frame: 48 hours post
Pressure pain threshold
Soreness
Time frame: 72 hours post
Pressure pain threshold
Muscle Structure
Time frame: Baseline
Muscle swelling - thigh girth + Ultrasound measurement
Muscle Structure
Time frame: Immediately post muscle damage intervention
Muscle swelling - thigh girth + Ultrasound measurement
Muscle Structure
Time frame: 24 hours post
Muscle swelling - thigh girth + Ultrasound measurement
Muscle Structure
Time frame: 48 hours post
Muscle swelling - thigh girth + Ultrasound measurement
Muscle Structure
Time frame: 72 hours post
Muscle swelling - thigh girth + Ultrasound measurement
Muscle Function
Time frame: Baseline
maximal strength
Muscle Function
Time frame: Immediately post muscle damage intervention
maximal strength
Muscle Function
Time frame: 24 hours post
maximal strength
Muscle Function
Time frame: 48 hours post
maximal strength
Muscle Function
Time frame: 72 hours post
maximal strength
Muscle Function
Time frame: Baseline
Muscular endurance
Muscle Function
Time frame: Immediately post muscle damage intervention
Muscular endurance
Muscle Function
Time frame: 24 hours post
Muscular endurance
Muscle Function
Time frame: 48 hours post
Muscular endurance
Muscle Function
Time frame: 72 hours post
Muscular endurance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- 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.
Luke Hughes, PhD principal investigator
Northumbria University
Jess Hill, PhD principal investigator
St. Mary's University, Twickenham
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin in people with Exercise Induced Muscle Damage, run by St Mary's University College.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luke Hughes, PhD (+447920004214, luke4.hughes@northumbria.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood markers (time frame: Baseline). The study lists 40 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 26 Apr 2022.