Determining the effect of curcumin on delayed onset muscle soreness
Design
A Crossover Randomized Control Trial, triple blinded on 15 sedentary people. Randomization will be used using blocks of size 4 carried out at a website: www.sealedenvelope.com
Settings and conduct
This study will conduct on 15 sedentary people who refer to sports medicine ward in Taleghani hospital. Demographic data, body composition information and knee extensor 1-RM will be entered to questionnaire.
Unilateral knee extension will be used as a DOMS protocol. (5 sets, 10 rep of 120% 1-RM).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Sedentary adult people.
Non-inclusion criteria: had participated in resistance training in the last 6 months; history of DOMS in the last 3 months, history of orthopedic diseases, arthritis and other inflammatory diseases; pregnancy and lactation; taking Curcumin supplement in the previous 6 months; participation in training session during the test time; using a specific strategy for recovery
Intervention groups
Intervention group: Participants will take Curcumin in 7 doses.
Control group: Participants will take Placebo in 7 doses.
Main outcome variables
Pain; swelling; muscle strength; range of motion (ROM); muscle function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191013045089N1
Registration date:2020-06-27, 1399/04/07
Registration timing:registered_while_recruiting
Last update:2020-06-27, 1399/04/07
Update count:0
Registration date
2020-06-27, 1399/04/07
Registrant information
Name
Behnaz Mahdaviani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1406
Email address
behnazmahdaviani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-09, 1399/03/20
Expected recruitment end date
2020-07-05, 1399/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Curcumin Supplement and Placebo in Improving Symptoms of Delayed Onset Muscle Soreness in Sedentary People
Public title
Curcumin effect on delayed onset muscle soreness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Sedentary people (people who do not participate in planned, structured physical activity at least 30 min at moderate intensity on at least 3 days per week during the last 3 months)
Exclusion criteria:
had participated in resistance training in the last six months
history of muskuloskeletal injury in the last 2 months
history of Delayed Onset Muscle Soreness (DOMS) in the last 3 months
history of orthopedic, arthritis and inflammatory diseases
regular consumption of medicine
regular consumption of Non Steroidal Anti Inflammatory Drugs (NSAIDs) (at least 3 of 7 days)
dietary supplements use in the previous 6 months
intake of a curcumin supplement within the past 6 months
history of Hypertension disease
history of gallbladder disease
Age
From 18 years old
Gender
Female
Phase
4
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
The order of placement in the drug and placebo groups and the performing DOMS protocol on the dominant or non-dominant leg will be determined by the block randomization method through blocks of size 4 (using sealed envelope).
Blinding (investigator's opinion)
Triple blinded
Blinding description
A triple- blinded trial is designed; knowledge of the treatment assignment is concealed from the people who organize and analyze the data of the study as well as from the subjects. As placebo and drug are exactly the same in shape and color, subjects will not be notified of group allocation status.
The statistician will also be unaware of the allocation of individuals to study groups. Only the supervisor will be notified.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Arabi street, Daneshjou boulevard, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-07-08, 1397/04/17
Ethics committee reference number
IR.SBMU.MSP.REC.1397.320
Health conditions studied
1
Description of health condition studied
Delayed Onset Muscle Soreness
ICD-10 code
ICD-10 code description
muscle
Primary outcomes
1
Description
Pain
Timepoint
before intervention, after intervention, on 1st, 3rd, and 7th day
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Swelling
Timepoint
before intervention, after intervention, on 1st and 3rd day
Method of measurement
tape measure
3
Description
Muscle Strength
Timepoint
before intervention, after intervention, on 1st and 3rd day
Method of measurement
One-repetition maximum (1-RM)
4
Description
Range of Motion
Timepoint
before intervention, after intervention, on 1st and 3rd day
Method of measurement
Goniometer
5
Description
Muscle Function
Timepoint
before intervention, after intervention, on 1st and 3rd day
Method of measurement
one-legged hop for distance test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: they will take 500 mg Curcumin supplement orally. They continue to take it for up to 7 days.
Category
Treatment - Drugs
2
Description
Control group: they will take placebo orally. They continue to take it up to 7 days.