Oxidative StressNCT03064958
The Acute Effect of Spices on Vascular Health
A study testing Herbs and spices and High fat meal in people with Oxidative Stress, run by Penn State University at 1 site in United States.
Trial summary
The investigators aim to conduct a 3-period randomized controlled crossover study to investigate the postprandial effects of a high fat meal with spice on endothelial function, lipids/lipoproteins, immune function and plasma markers of antioxidants and oxidative stress. Metabolomic profiling will also be conducted. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Herbs and spices and High fat meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2016to 29 Mar 2018
- 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 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male aged 40-65 years
- BMI 25-35kg/m2
- nonsmoking
- waist circumference =/> 94cm and at least one other CVD risk factor (elevated LDL-C (> 130 mg/dL), CRP (> 1 mg/L), elevated Triglycerides (≥ 150 mg/dL), reduced HDL-cholesterol (< 40 mg/dL), elevated blood pressure (systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg), elevated fasting glucose (≥ 100 mg/dL))
- low herb/spice consumers (consumption <1/day)
Who cannot join
- Chronic disease risk factors that are diagnostic of diabetes (fasting glucose > 126 mg/dL) or hypertension (SBP >160 mm Hg or DBP > 100 mm Hg).
- Prescription of anti-hypertensive or glucose lowering drugs.
- Established CVD, stroke, diabetes, liver, kidney or autoimmune disease
- Use of cholesterol/lipid-lowering medication or supplements (psyllium, fish oil, soy lecithin, and phytoestrogens) and botanicals
- weight loss of ≥10% of body weight within the 6 months prior to enrolling in the study
- vegetarianism
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
About this study
Official title: The Postprandial Effects of a High Fat Meal Containing Spices on Endothelial Function: a Pilot Study
The investigators aim to conduct a 3-period randomized controlled crossover study to investigate the postprandial effects of a high fat meal with spice on endothelial function, lipids/lipoproteins, immune function and plasma markers of antioxidants and oxidative stress. Metabolomic profiling will also be conducted. In random order, participants will consume either a high fat meal (1000kcal, 45g fat) or a high fat meal containing 2g of spice or a high fat meal containing 6g of spice. Between each treatment there will be a washout period of at least 3 days. It is hypothesized that consumption of a high fat meal with spice will attenuate postprandial endothelial impairment and triglyceride levels in a dose response manner compared with a high fat meal.
Read the detailed description
A 3-period randomized controlled crossover study will be conducted to investigate the postprandial effects of a high fat meal with spices on endothelial function, lipids/lipoproteins, immune function, plasma antioxidants and markers of oxidative stress. Metabolomic profiling will also be conducted. In random order participants will consume either a high fat meal (1000kcal, 45g fat) or a high fat meal containing 2g of spices or a high fat meal containing 6g of spices with a 3 day washout period between each treatment. The following spices will be incorporated into the meal black pepper, basil, bay leaf, cinnamon, coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme.
Endothelial function will be measured by flow mediated dilation of the brachial artery in the fasting state and 2 and 4 hours after the meal. Participants will also provide a fasting blood sample and samples will also be taken at 1, 2, 3 and 4 hours after the meal.
- Conditions
- Oxidative Stress
- Being tested
- Herbs and spices, High fat meal
- Keywords
- glucose regulation, lipids, Immune markers, Endothelium, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbs and spicesOther
Mix of commonly used herbs and spices
High fat mealOther
Meal containing 1000kcal and 45g fat
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Consumption of a high fat meal (1000kcal, 45g fat) Receives: Other: High fat meal |
| Spice 2g | Experimental | Consumption of a high fat meal (1000kcal, 45g fat) with 2g of spice (mix of black pepper, basil, bay leaf, cinnamon, coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme) incorporated into the meal. Receives: Other: Herbs and spices; Other: High fat meal |
| Spice 6g | Experimental | Consumption of a high fat meal (1000kcal, 45g fat) with 6g of spice (mix of black pepper, basil, bay leaf, cinnamon, coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme) incorporated into the meal. Receives: Other: Herbs and spices; Other: High fat meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endothelial function measured by flow mediated dilation (FMD) of the brachial artery
Measured: Change from baseline at 2 hours and 4 hours after meal consumption
Secondary outcomes (9)
Lipids and lipoproteins
Measured: Change from baseline during the 4 hours after meal consumption
Plasma Inflammatory cytokines
Measured: Change from baseline during the 4 hours after meal consumption
Inflammatory cytokines in isolated peripheral blood mononuclear cells
Measured: Change from baseline during the 4 hours after meal consumption
Glucose
Measured: Change from baseline during the 4 hours after meal consumption
Insulin
Measured: Change from baseline during the 4 hours after meal consumption
Plasma antioxidants (hydrophilic ORAC, lipophilic ORAC, total ORAC)
Measured: Change from baseline during the 4 hours after meal consumption
Oxidative stress
Measured: Change from baseline during the 4 hours after meal consumption
Plasma nitrite and nitrate
Measured: Change from baseline during the 4 hours after meal consumption
Plasma and Urine Metabolomic profiling
Measured: Change from baseline during the 4 hours after meal consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start13 Sep 2016
- Primary completion29 Mar 2018
- Study completion29 Mar 2018
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 Oxidative StressStudies 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- McCormick Science Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064958
- Sponsor's protocol ID
- PKE SPICE PILOT
- Status last verified
- Aug 2023
- First submitted
- 14 Sep 2016
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Oh ES, Petersen KS, Kris-Etherton PM, Rogers CJ. Spices in a High-Saturated-Fat, High-Carbohydrate Meal Reduce Postprandial Proinflammatory Cytokine Secretion in Men with Overweight or Obesity: A 3-Period, Crossover, Randomized Controlled Trial. J Nutr. 2020 Jun 1;150(6):1600-1609. doi: 10.1093/jn/nxaa063.
PubMed 32211803
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Postprandial Effects of a High Fat Meal Containing Spices on Endothelial Function: a Pilot Study
- ClinicalTrials.gov ID
- NCT03064958
- Acronym / sponsor ID
- PKE SPICE PILOT
- Conditions
- Oxidative Stress
- Keywords
- glucose regulation, lipids, Immune markers, Endothelium, Vascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- McCormick Science Institute
- Study start
- 13 Sep 2016 (actual)
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 27 Feb 2017 (actual)
- 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 investigators aim to conduct a 3-period randomized controlled crossover study to investigate the postprandial effects of a high fat meal with spice on endothelial function, lipids/lipoproteins, immune function and plasma markers of antioxidants and oxidative stress. Metabolomic profiling will also be conducted. In random order, participants will consume either a high fat meal (1000kcal, 45g fat) or a high fat meal containing 2g of spice or a high fat meal containing 6g of spice. Between each treatment there will be a washout period of at least 3 days. It is hypothesized that consumption of a high fat meal with spice will attenuate postprandial endothelial impairment and triglyceride levels in a dose response manner compared with a high fat meal.
Detailed description
A 3-period randomized controlled crossover study will be conducted to investigate the postprandial effects of a high fat meal with spices on endothelial function, lipids/lipoproteins, immune function, plasma antioxidants and markers of oxidative stress. Metabolomic profiling will also be conducted. In random order participants will consume either a high fat meal (1000kcal, 45g fat) or a high fat meal containing 2g of spices or a high fat meal containing 6g of spices with a 3 day washout period between each treatment. The following spices will be incorporated into the meal black pepper, basil, bay leaf, cinnamon, coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme.
Endothelial function will be measured by flow mediated dilation of the brachial artery in the fasting state and 2 and 4 hours after the meal. Participants will also provide a fasting blood sample and samples will also be taken at 1, 2, 3 and 4 hours after the meal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: High fat mealConsumption of a high fat meal (1000kcal, 45g fat) |
| Spice 2g | Experimental | Other: Herbs and spices, Other: High fat mealConsumption of a high fat meal (1000kcal, 45g fat) with 2g of spice (mix of black pepper, basil, bay leaf, cinnamon, coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme) incorporated into the meal. |
| Spice 6g | Experimental | Other: Herbs and spices, Other: High fat mealConsumption of a high fat meal (1000kcal, 45g fat) with 6g of spice (mix of black pepper, basil, bay leaf, cinnamon, coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme) incorporated into the meal. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male aged 40-65 years
- BMI 25-35kg/m2
- nonsmoking
- waist circumference =/> 94cm and at least one other CVD risk factor (elevated LDL-C (> 130 mg/dL), CRP (> 1 mg/L), elevated Triglycerides (≥ 150 mg/dL), reduced HDL-cholesterol (< 40 mg/dL), elevated blood pressure (systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg), elevated fasting glucose (≥ 100 mg/dL))
- low herb/spice consumers (consumption <1/day)
Key exclusion criteria (6 listed)
- Chronic disease risk factors that are diagnostic of diabetes (fasting glucose > 126 mg/dL) or hypertension (SBP >160 mm Hg or DBP > 100 mm Hg).
- Prescription of anti-hypertensive or glucose lowering drugs.
- Established CVD, stroke, diabetes, liver, kidney or autoimmune disease
- Use of cholesterol/lipid-lowering medication or supplements (psyllium, fish oil, soy lecithin, and phytoestrogens) and botanicals
- weight loss of ≥10% of body weight within the 6 months prior to enrolling in the study
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 |
|---|---|---|
| Herbs and spicesMix of commonly used herbs and spices | Other | Spice 2g, Spice 6g |
| High fat mealMeal containing 1000kcal and 45g fat | Other | Control, Spice 2g, Spice 6g |
Primary outcome
Change in endothelial function measured by flow mediated dilation (FMD) of the brachial artery
Time frame: Change from baseline at 2 hours and 4 hours after meal consumption
9 secondary outcomes
Lipids and lipoproteins
Time frame: Change from baseline during the 4 hours after meal consumption
Plasma Inflammatory cytokines
Time frame: Change from baseline during the 4 hours after meal consumption
Inflammatory cytokines in isolated peripheral blood mononuclear cells
Time frame: Change from baseline during the 4 hours after meal consumption
Glucose
Time frame: Change from baseline during the 4 hours after meal consumption
Insulin
Time frame: Change from baseline during the 4 hours after meal consumption
Plasma antioxidants (hydrophilic ORAC, lipophilic ORAC, total ORAC)
Time frame: Change from baseline during the 4 hours after meal consumption
Oxidative stress
Time frame: Change from baseline during the 4 hours after meal consumption
Plasma nitrite and nitrate
Time frame: Change from baseline during the 4 hours after meal consumption
Plasma and Urine Metabolomic profiling
Time frame: Change from baseline during the 4 hours after meal consumption
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 21 Aug 2023.
- Derived from this study: PubMed 32211803Oh ES, Petersen KS, Kris-Etherton PM, Rogers CJ. Spices in a High-Saturated-Fat, High-Carbohydrate Meal Reduce Postprandial Proinflammatory Cytokine Secretion in Men with Overweight or Obesity: A 3-Period, Crossover, Randomized Controlled Trial. J Nutr. 2020 Jun 1;150(6):1600-1609. doi: 10.1093/jn/nxaa063.
- Individual participant dataSharing planned: No
Related trials for Oxidative Stress
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
RecruitingObservational study
Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease
Gaucher Disease Type I, Oxidative Stress
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herbs and spices and High fat meal in people with Oxidative 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 6 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 21 Aug 2023. 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. 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?
Change in endothelial function measured by flow mediated dilation (FMD) of the brachial artery (time frame: Change from baseline at 2 hours and 4 hours after meal consumption). 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 NCT03064958, 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 21 Aug 2023.