An interventional study of Curcumin and Placebo in Vascular Stiffness, sponsored by University of Prince Edward Island. Withdrawn. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-23.
Sponsored by University of Prince Edward Island · Not applicable, Interventional, and Prevention
Arterial Stiffness: As a recognized independent indicator of cardiovascular risk, maintaining low levels of arterial stiffening is important to cardiovascular health. Increases in arterial stiffening results in elevated systolic and mean pressure and it is correlated with various cardiovascular conditions such as left ventricular hypertrophy, ischaemic heart disease, and myocardial infarction. In contrast, decreased arterial stiffness improves ventricular-vascular coupling, ejection fraction, and cardiac output. Arterial stiffness is linked to inflammation and oxidative stress. Both inflammation and oxidative stress are elevated during DOMS (delayed onset muscle soreness), a state brought on by muscle damage often incurred during strenuous exercise. Recent studies have shown that a single bout of eccentric exercise can produce acute arterial stiffness during recovery. However, anti-oxidants/anti-inflammatories may be effective in reducing the extent of damage by decreasing oxidation and inflammation. Curcumin is a powerful antioxidant that could act as an anti-inflammatory and diminish the effects of the downhill run. In addition, eccentric damage generates a prophylactic protection lasting up to six weeks. The nature of the downhill run is primarily eccentric in nature. Therefore, repeated bouts may have diminished DOMS development. Any reduction in stress by either the prophylactic repeated bout effect or the Curcumin supplement, should attenuate the increase in arterial stiffness due to the reduction in inflammation.
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:
University of Prince Edward Island is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
200 mg, curcuminoids, 7d of supplementation in capsular form
Dietary Supplement: Curcumin
sucrose, capsular
Dietary Supplement: Placebo
333mg CurcuWin OAHTCUR002-2014
Also known as: Tumeric extract
OAHTCUR005-2014
Arterial Stiffness
This will be measured using arterial tonometry
Time frame: Every 24 hr up to 72hr post baseline
Blood measures of inflammation and muscle damage
Interleukin-6, highsensitivity C-reactive protein, Creatine Kinase
Time frame: Every 24 hr up to 72hr post baseline
Delayed onset muscle soreness
Subjective analogue scale
Time frame: Every 24 hr up to 72hr post baseline
No study locations are listed for this record.
This study is withdrawn, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Curcumin
University of Prince Edward Island