- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02281981
The Effects of Repeated Bouts of Downhill Running and Curcumin Supplementation on Arterial Stiffness During Recovery (Cur)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Baseline Participants will report to the lab on day one to have basic anthropometry and clinical measures performed. Following measures of height, weight, blood pressure, blood lipids (fasting glucose), creatine kinase, high sensitivity C-reactive protein (HS-CRP) and interleukin-6 (IL-6) participants will be allowed to eat a small standardized snack. Participants will then have measures of baseline muscle soreness and leg strength measured prior to a VO2max test on a cycle ergometer.
Muscle Soreness will be measured using a standard 10cm analogue scale and girth of the thigh will be recorded to account for possible alterations owing to local inflammation/oedema./ Creatine Kinase (CK) will be tracked as a measure of damage.
The test termination criteria for the VO2max will include: volitional fatigue, a participant rating of perceived exertion of 19-20 (on a scale from 0-20), a plateau in O2 uptake with increasing workload, or and RER of >1.15. The VT of each participant will be noted to compare with values post- training.
Testing Day 2 - This day will occur at least 1 full day (48h) following VO2max testing.
Participants will arrive at the lab having consumed a standardized breakfast. Prior to the downhill run, measures of pulse wave velocity (PWV), heart rate variability (HRV), flow mediated dilatation (FMD) will be collected according to the protocols to follow. Participants will then perform a 40 minute downhill run at a grade of -12 percent using a speed that elicits a VO2 of approximately 60% of the maximum value achieved during the max test.
Arterial stiffness will be determined using a Sphygmocor CPVH pulse wave applanation tonomoter (Atcor Medical). This device measures arterial pulse waves non-invasively through the skin. By matching pulse wave arrival with heart beats (through a standard ECG tracing) and measuring the distance between points we can calculate travel time (or velocity). We will also use this same device to analyze the shape of the pulse wave, which will give us information about reflected pulse waves (and thus the stiffness of the arterial tree).
Follow-up: At 24h, 48h, and 72h post exercise, participants will return to the lab to have all of the non-exercise measures repeated (see figure 1). This will allow temporal tracking over time.
Hypotheses:
1) The anti-inflammatory potential of Curcumin supplementation should improve post-exercise recovery. 2) Repeated bouts of eccentrically biased downhill running should produce a prophylactic effect and reduce arterial stiffness and recovery time
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects will be male or female
- 18yr - 45yr
- Free from any known or suspected chronic conditions.
- General health and suitability to participate in an exercise/health research study will be confirmed through use of the PAR-Q+ screening questionnaire
Exclusion Criteria:
- Any participant who has a positive answer to a screening question will be required to seek physician approval prior to any physical exercise.
- Baseline arrhythmia (tachycardia (>100pbm) and systolic or diastolic hypertension (>140/90 mmHg) will also be reason for exclusion.
- During baseline anthropometric assessment we will confirm that participants all fall within a typical BMI range (20-30 kg/m2) of either "normal" weight or "overweight", but not "underweight" or "obese".
- Persons who take cardiovascular medications, metabolic medications, smoke cigarettes, excessively consume alcohol, are prone to heartburn, or have a previous diagnosis of hyperlipidemia or hyperinsulemia will also be excluded
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Curcumin supplement
200 mg, curcuminoids, 7d of supplementation in capsular form
|
333mg CurcuWin OAHTCUR002-2014
Other Names:
|
Placebo Comparator: Placebo
sucrose, capsular
|
OAHTCUR005-2014
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arterial Stiffness
Time Frame: Every 24 hr up to 72hr post baseline
|
This will be measured using arterial tonometry
|
Every 24 hr up to 72hr post baseline
|
Blood measures of inflammation and muscle damage
Time Frame: Every 24 hr up to 72hr post baseline
|
Interleukin-6, highsensitivity C-reactive protein, Creatine Kinase
|
Every 24 hr up to 72hr post baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delayed onset muscle soreness
Time Frame: Every 24 hr up to 72hr post baseline
|
Subjective analogue scale
|
Every 24 hr up to 72hr post baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jamie F Burr, PhD, UPEI
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
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
- curcumin
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.
Clinical Trials on Vascular Stiffness
-
Mayo ClinicNot yet recruiting
-
WithingsNot yet recruiting
-
Bangkok Metropolitan Administration Medical College...Completed
-
Ospedale Regionale di LocarnoCompletedVascular Stiffness
-
Maastricht University Medical CenterUnknown
-
University Hospital, RouenInstitut National de la Santé Et de la Recherche Médicale, FranceUnknownHealthy | Aging | Vascular StiffnessFrance
-
St. Boniface HospitalUnknownCardiovascular Diseases | Vascular StiffnessCanada
-
University of IowaCompletedAging | Endothelial Dysfunction | Vascular StiffnessUnited States
-
Northumbria UniversityCompletedCognitive Change | Blood Pressure | Vascular StiffnessUnited Kingdom
-
University of California, Los AngelesRecruitingVascular Stiffness | Vaping | Hookah Smoking | Secondhand AerosolUnited States
Clinical Trials on Curcumin
-
H.K.E.S's S.Nijalingappa Institute of Dental Science...Unknown
-
Université de SherbrookeUnknown
-
Daniel DobererCompleted
-
Federico II UniversityCompleted
-
Kaiser PermanenteCompletedIrritable Bowel SyndromeUnited States
-
Woodbury, Michel, M.D.Lawson Health Research InstituteCompletedDepression | Schizophrenia | Schizoaffective DisorderPuerto Rico
-
Louisiana State University Health Sciences Center...TerminatedMild Cognitive ImpairmentUnited States
-
Gary MorrowNational Cancer Institute (NCI)CompletedPain | Breast Carcinoma | Stage 0 Breast Cancer | Radiation-Induced DermatitisUnited States
-
Emory UniversityCompletedUterine Cervical DysplasiaUnited States
-
Lawson Health Research InstituteCanadian Institutes of Health Research (CIHR)CompletedAcute Kidney Injury | Abdominal Aortic AneurysmCanada