- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05346211
The Effect of Curcumin Supplementation on Recovery From Exercise-induced Muscle Damage
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Luke Hughes, PhD
- Phone Number: +447920004214
- Email: luke4.hughes@northumbria.ac.uk
Study Contact Backup
- Name: Ian Grant, MSc
- Phone Number: 020 8240 4000
- Email: ian.grant@stmarys.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Inclusion criteria are as follows:
- 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
Exclusion Criteria:
Exclusion criteria include:
- hypertension (<140/80)
- any blood diseases or clotting issues,
- injury, or previous injury in <3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Curcumin Single
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). |
Curcumin Supplementation
|
|
Experimental: Curcumin Double
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). |
Curcumin Supplementation
|
|
No Intervention: Placebo
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline
|
|
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
|
immediately post muscle damage intervention
|
|
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
|
24 hours post
|
|
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
|
48 hours post
|
|
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
|
72 hours post
|
|
Ford and Fort
Time Frame: Baseline
|
Capillary sample Ford and Fort tests
|
Baseline
|
|
Ford and Fort
Time Frame: Immediately post muscle damage intervention
|
Capillary sample Ford and Fort tests
|
Immediately post muscle damage intervention
|
|
Ford and Fort
Time Frame: 24 hours post
|
Capillary sample Ford and Fort tests
|
24 hours post
|
|
Ford and Fort
Time Frame: 48 hours post
|
Capillary sample Ford and Fort tests
|
48 hours post
|
|
Ford and Fort
Time Frame: 72 hours post
|
Capillary sample Ford and Fort tests
|
72 hours post
|
|
Soreness
Time Frame: Baseline
|
Perceived muscle soreness scale - Visual analouge scale
|
Baseline
|
|
Soreness
Time Frame: Immediately post muscle damage intervention
|
Perceived muscle soreness scale - Visual analouge scale
|
Immediately post muscle damage intervention
|
|
Soreness
Time Frame: 24 hours post
|
Perceived muscle soreness scale - Visual analouge scale
|
24 hours post
|
|
Soreness
Time Frame: 48 hours post
|
Perceived muscle soreness scale - Visual analouge scale
|
48 hours post
|
|
Soreness
Time Frame: 72 hours post
|
Perceived muscle soreness scale - Visual analouge scale
|
72 hours post
|
|
Soreness
Time Frame: Baseline
|
BORG CR-10 scale
|
Baseline
|
|
Soreness
Time Frame: Immediately post muscle damage intervention
|
BORG CR-10 scale
|
Immediately post muscle damage intervention
|
|
Soreness
Time Frame: 24 hours post
|
BORG CR-10 scale
|
24 hours post
|
|
Soreness
Time Frame: 48 hours post
|
BORG CR-10 scale
|
48 hours post
|
|
Soreness
Time Frame: 72 hours post
|
BORG CR-10 scale
|
72 hours post
|
|
Soreness
Time Frame: Baseline
|
Pressure pain threshold
|
Baseline
|
|
Soreness
Time Frame: Immediately post muscle damage intervention
|
Pressure pain threshold
|
Immediately post muscle damage intervention
|
|
Soreness
Time Frame: 24 hours post
|
Pressure pain threshold
|
24 hours post
|
|
Soreness
Time Frame: 48 hours post
|
Pressure pain threshold
|
48 hours post
|
|
Soreness
Time Frame: 72 hours post
|
Pressure pain threshold
|
72 hours post
|
|
Muscle Structure
Time Frame: Baseline
|
Muscle swelling - thigh girth + Ultrasound measurement
|
Baseline
|
|
Muscle Structure
Time Frame: Immediately post muscle damage intervention
|
Muscle swelling - thigh girth + Ultrasound measurement
|
Immediately post muscle damage intervention
|
|
Muscle Structure
Time Frame: 24 hours post
|
Muscle swelling - thigh girth + Ultrasound measurement
|
24 hours post
|
|
Muscle Structure
Time Frame: 48 hours post
|
Muscle swelling - thigh girth + Ultrasound measurement
|
48 hours post
|
|
Muscle Structure
Time Frame: 72 hours post
|
Muscle swelling - thigh girth + Ultrasound measurement
|
72 hours post
|
|
Muscle Function
Time Frame: Baseline
|
maximal strength
|
Baseline
|
|
Muscle Function
Time Frame: Immediately post muscle damage intervention
|
maximal strength
|
Immediately post muscle damage intervention
|
|
Muscle Function
Time Frame: 24 hours post
|
maximal strength
|
24 hours post
|
|
Muscle Function
Time Frame: 48 hours post
|
maximal strength
|
48 hours post
|
|
Muscle Function
Time Frame: 72 hours post
|
maximal strength
|
72 hours post
|
|
Muscle Function
Time Frame: Baseline
|
Muscular endurance
|
Baseline
|
|
Muscle Function
Time Frame: Immediately post muscle damage intervention
|
Muscular endurance
|
Immediately post muscle damage intervention
|
|
Muscle Function
Time Frame: 24 hours post
|
Muscular endurance
|
24 hours post
|
|
Muscle Function
Time Frame: 48 hours post
|
Muscular endurance
|
48 hours post
|
|
Muscle Function
Time Frame: 72 hours post
|
Muscular endurance
|
72 hours post
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Luke Hughes, PhD, Northumbria University
- Principal Investigator: Jess Hill, PhD, St. Mary's University, Twickenham
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- ASE22HELCON
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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