Vascular StiffnessCurNCT02281981
The Effects of Repeated Bouts of Downhill Running and Curcumin Supplementation on Arterial Stiffness During Recovery
A study testing Curcumin in people with Vascular Stiffness, run by University of Prince Edward Island.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Stiffness
- What is being tested?
- Curcumin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jan 2016
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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:
- 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
- Conditions
- Vascular Stiffness
- Being tested
- Curcumin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
Also called Tumeric extract
333mg CurcuWin OAHTCUR002-2014
PlaceboDietary supplement
OAHTCUR005-2014
| Study group | Role | What they receive |
|---|---|---|
| Curcumin supplement | Experimental | 200 mg, curcuminoids, 7d of supplementation in capsular form Receives: Dietary Supplement: Curcumin |
| Placebo | Placebo comparator | sucrose, capsular Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Stiffness
This will be measured using arterial tonometry
Measured: Every 24 hr up to 72hr post baseline
Blood measures of inflammation and muscle damage
Interleukin-6, highsensitivity C-reactive protein, Creatine Kinase
Measured: Every 24 hr up to 72hr post baseline
Secondary outcomes (1)
Delayed onset muscle soreness
Subjective analogue scale
Measured: Every 24 hr up to 72hr post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2015 (estimated)
- Study completionJan 2016 (estimated)
Why it stopped: Project abandoned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular StiffnessStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Prince Edward Island
- Sponsor type
- University, hospital or other
- Collaborators
- OmniActive Health Technologies
- Responsible party
- Principal investigator, Dr. Jamie Burr, University of Prince Edward Island
- Investigators
- Jamie F Burr, PhD, Principal investigator, UPEI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281981
- Sponsor's protocol ID
- Curcumin
- Acronym
- Cur
- Status last verified
- Jun 2022
- First submitted
- 29 Oct 2014
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Repeated Bouts of Downhill Running and Curcumin Supplementation on Arterial Stiffness During Recovery
- ClinicalTrials.gov ID
- NCT02281981
- Acronym / sponsor ID
- Cur / Curcumin
- Conditions
- Vascular Stiffness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project abandoned
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Prince Edward IslandUniversity, hospital or other
- Collaborators
- OmniActive Health Technologies
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 4 Nov 2014 (estimated)
- 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.
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.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curcumin supplement | Experimental | Dietary Supplement: Curcumin200 mg, curcuminoids, 7d of supplementation in capsular form |
| Placebo | Placebo comparator | Dietary Supplement: Placebosucrose, capsular |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| CurcuminAlso: Tumeric extract333mg CurcuWin OAHTCUR002-2014 | Dietary supplement | Curcumin supplement |
| PlaceboOAHTCUR005-2014 | Dietary supplement | Placebo |
Primary outcome
Arterial Stiffness
Time frame: Every 24 hr up to 72hr post baseline
This will be measured using arterial tonometry
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
1 secondary outcome
Delayed onset muscle soreness
Time frame: Every 24 hr up to 72hr post baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
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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.
Jamie F Burr, PhD principal investigator
UPEI
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin in people with Vascular Stiffness, run by University of Prince Edward Island.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 23 Jun 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial Stiffness (time frame: Every 24 hr up to 72hr post baseline). The study lists 2 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 23 Jun 2022.