NCT02281981

Brief 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 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

June 23, 2022

Status Verified

June 1, 2022

Enrollment Period

1 year

First QC Date

October 29, 2014

Last Update Submit

June 16, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Arterial Stiffness

    This will be measured using arterial tonometry

    Every 24 hr up to 72hr post baseline

  • Blood measures of inflammation and muscle damage

    Interleukin-6, highsensitivity C-reactive protein, Creatine Kinase

    Every 24 hr up to 72hr post baseline

Secondary Outcomes (1)

  • Delayed onset muscle soreness

    Every 24 hr up to 72hr post baseline

Study Arms (2)

Curcumin supplement

EXPERIMENTAL

200 mg, curcuminoids, 7d of supplementation in capsular form

Dietary Supplement: Curcumin

Placebo

PLACEBO COMPARATOR

sucrose, capsular

Dietary Supplement: Placebo

Interventions

CurcuminDIETARY_SUPPLEMENT

333mg CurcuWin OAHTCUR002-2014

Also known as: Tumeric extract
Curcumin supplement
PlaceboDIETARY_SUPPLEMENT

OAHTCUR005-2014

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects will be male or female
  • yr - 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

You may not qualify if:

  • Any participant who has a positive answer to a screening question will be required to seek physician approval prior to any physical exercise.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Curcumin

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Jamie F Burr, PhD

    UPEI

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 29, 2014

First Posted

November 4, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2016

Last Updated

June 23, 2022

Record last verified: 2022-06