CardiovascularSpiceNCT00954902
Effects of Antioxidants on Cardiovascular Risk Measures (Spice Study)
A study testing High Antioxidant Spice Blend and Trier Psychological Stressor in people with Cardiovascular and Psychological Stress, run by Penn State University at 1 site in United States.
Trial summary
The purpose of this study is to assess whether feeding highly antioxidant spices of providing these same antioxidants as capsules is able to affect cardiovascular risk measures. Because this is a new area of research, the investigators will use many measures to assess this question including blood markers, tests of… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular, Psychological Stress
- What is being tested?
- High Antioxidant Spice Blend and Trier Psychological Stressor
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Sep 2010
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 30-65
- BMI 25-40
- Non tobacco user
- Resting BP < 160/100
- Fasting Glucose < 126 mg/dL
Who cannot join
- Tobacco use
- Use of female hormones
- Breastfeeding or planning to become pregnant during the study
- Use of lipid-lowering or blood pressure medications
- Chronic Inflammatory Disease or osteoarthritis requiring regular use of medication
- Chronic use of any form of anti-inflammatory or anti-psychotic drugs
Show all 13Show fewer
- Use of daily aspirin or supplements (except stable dose of calcium)
- History of heart attack or stroke, renal or hepatic disease, implanted medical devices, gastrointestinal disease
- Allergy or intolerance to any study foods
- Injury to fingers or arms that would interfere with vascular and blood pressure measurements
- Inability to comply with study protocol
- Allergy to adhesives or latex
- Aerobic exercise exceeding 2 hours per week
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State GCRC
University Park, Pennsylvania, 16802
About this study
Official title: Development of a Dynamic Model of Inflammation for Studying the Anti-inflammatory Effects of Culinary Spices in Human Participants
The purpose of this study is to assess whether feeding highly antioxidant spices of providing these same antioxidants as capsules is able to affect cardiovascular risk measures. Because this is a new area of research, the investigators will use many measures to assess this question including blood markers, tests of blood vessel health, measures of blood pressure responses, measures of clotting activity, and other inflammation measures.
- Conditions
- Cardiovascular, Psychological Stress
- Being tested
- High Antioxidant Spice Blend, Trier Psychological Stressor, Placebo antioxidant concentrate
- Keywords
- Spice, responses to stress, Inflammatory
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Antioxidant Spice BlendDietary supplement
14.5 g spice blend incorporated into a delivery meal including: cloves, cinnamon, oregano, rosemary, ginger, black pepper, paprika, garlic powder, and turmeric.
Trier Psychological StressorBehavioural
This is a psychological stressor that is used to invoked stress responses in human subjects. Subjects are told they are taped and evaluated and deliver the speech in front of a trained panel of judges.
Placebo antioxidant concentrateOther
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| No spice, no stress | Sham comparator | Subject are given placebo capsules and told they contain an antioxidant concentrate Receives: Other: Placebo antioxidant concentrate |
| No Spice, Stress | Sham comparator | Subjects are given placebo capsules and told they are receiving an equivalent amount of an antioxidant concentrate. Receives: Behavioral: Trier Psychological Stressor; Other: Placebo antioxidant concentrate |
| Spice, no stress | Experimental | Not described Receives: Dietary Supplement: High Antioxidant Spice Blend |
| Spice and Stress | Experimental | Not described Receives: Dietary Supplement: High Antioxidant Spice Blend; Behavioral: Trier Psychological Stressor |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-6 response to psychological stress at time points equal to and greater than 90 minutes post task
Measured: At baseline and intervals up to 2 hours following the stressor and 3.5 hours following the meal
Secondary outcomes (3)
Serum/plasma changes in antioxidant activity and their relationship to inflammation outcomes
Measured: At baseline and intervals up to 2 hours following the stressor and 3.5 hours following the meal
Endothelial function measured by endopat
Measured: At baseline and 3.5 hours following the meal
Platelet function measured by PFA-100
Measured: At baseline and specified intervals up to 2 hours following the stressor and 3.5 hours following the meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CardiovascularStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- McCormick Science Institute
- Responsible party
- Principal investigator, Sheila G West, Penn State University
- Investigators
- Sheila G. West, PhD, Principal investigator, Penn StateAnn C. Skulas-Ray, B.S., Principal investigator, Penn StatePenny M. Kris-Etherton, PhD, RD, Principal investigator, Penn State
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954902
- Sponsor's protocol ID
- G264
- Acronym
- Spice
- Status last verified
- Jan 2018
- First submitted
- 6 Aug 2009
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
McCrea CE, West SG, Kris-Etherton PM, Lambert JD, Gaugler TL, Teeter DL, Sauder KA, Gu Y, Glisan SL, Skulas-Ray AC. Effects of culinary spices and psychological stress on postprandial lipemia and lipase activity: results of a randomized crossover study and in vitro experiments. J Transl Med. 2015 Jan 16;13:7. doi: 10.1186/s12967-014-0360-5.
PubMed 25592751
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Dynamic Model of Inflammation for Studying the Anti-inflammatory Effects of Culinary Spices in Human Participants
- ClinicalTrials.gov ID
- NCT00954902
- Acronym / sponsor ID
- Spice / G264
- Conditions
- Cardiovascular, Psychological Stress
- Keywords
- Spice, responses to stress, Inflammatory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- McCormick Science Institute
- Study start
- Aug 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 7 Aug 2009 (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.
The purpose of this study is to assess whether feeding highly antioxidant spices of providing these same antioxidants as capsules is able to affect cardiovascular risk measures. Because this is a new area of research, the investigators will use many measures to assess this question including blood markers, tests of blood vessel health, measures of blood pressure responses, measures of clotting activity, and other inflammation measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No spice, no stress | Sham comparator | Other: Placebo antioxidant concentrateSubject are given placebo capsules and told they contain an antioxidant concentrate |
| No Spice, Stress | Sham comparator | Behavioral: Trier Psychological Stressor, Other: Placebo antioxidant concentrateSubjects are given placebo capsules and told they are receiving an equivalent amount of an antioxidant concentrate. |
| Spice, no stress | Experimental | Dietary Supplement: High Antioxidant Spice Blend |
| Spice and Stress | Experimental | Dietary Supplement: High Antioxidant Spice Blend, Behavioral: Trier Psychological Stressor |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 30-65
- BMI 25-40
- Non tobacco user
- Resting BP < 160/100
- Fasting Glucose < 126 mg/dL
Key exclusion criteria (13 listed)
- Tobacco use
- Use of female hormones
- Breastfeeding or planning to become pregnant during the study
- Use of lipid-lowering or blood pressure medications
- Chronic Inflammatory Disease or osteoarthritis requiring regular use of medication
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 |
|---|---|---|
| High Antioxidant Spice Blend14.5 g spice blend incorporated into a delivery meal including: cloves, cinnamon, oregano, rosemary, ginger, black pepper, paprika, garlic powder, and turmeric. | Dietary supplement | Spice and Stress, Spice, no stress |
| Trier Psychological StressorThis is a psychological stressor that is used to invoked stress responses in human subjects. Subjects are told they are taped and evaluated and deliver the speech in front of a trained panel of judges. | Behavioural | No Spice, Stress, Spice and Stress |
| Placebo antioxidant concentratePlacebo capsules | Other | No Spice, Stress, No spice, no stress |
Primary outcome
IL-6 response to psychological stress at time points equal to and greater than 90 minutes post task
Time frame: At baseline and intervals up to 2 hours following the stressor and 3.5 hours following the meal
3 secondary outcomes
Serum/plasma changes in antioxidant activity and their relationship to inflammation outcomes
Time frame: At baseline and intervals up to 2 hours following the stressor and 3.5 hours following the meal
Endothelial function measured by endopat
Time frame: At baseline and 3.5 hours following the meal
Platelet function measured by PFA-100
Time frame: At baseline and specified intervals up to 2 hours following the stressor and 3.5 hours following the meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Derived from this study: PubMed 25592751McCrea CE, West SG, Kris-Etherton PM, Lambert JD, Gaugler TL, Teeter DL, Sauder KA, Gu Y, Glisan SL, Skulas-Ray AC. Effects of culinary spices and psychological stress on postprandial lipemia and lipase activity: results of a randomized crossover study and in vitro experiments. J Transl Med. 2015 Jan 16;13:7. doi: 10.1186/s12967-014-0360-5.
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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.
Sheila G. West, PhD principal investigator
Penn State
Ann C. Skulas-Ray, B.S. principal investigator
Penn State
Penny M. Kris-Etherton, PhD, RD principal investigator
Penn State
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Antioxidant Spice Blend and Trier Psychological Stressor in people with Cardiovascular and Psychological Stress, run by Penn State University at 1 site in United States.
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 5 inclusion and 13 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: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IL-6 response to psychological stress at time points equal to and greater than 90 minutes post task (time frame: At baseline and intervals up to 2 hours following the stressor and 3.5 hours following the meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00954902, which also lists 1 linked publication.
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 25 Jan 2018.