Clinical trial NCT03064958: The Acute Effect of Spices on Vascular Health
Official title: The Postprandial Effects of a High Fat Meal Containing Spices on Endothelial Function: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Keywords: glucose regulation
lipids
Immune markers
Endothelium, Vascular
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: McCormick Science Institute
First posted: 2017-02-27
Enrollment: 13
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in endothelial function measured by flow mediated dilation (FMD) of the brachial artery
timeFrame: Change from baseline at 2 hours and 4 hours after meal consumption
Secondary outcomes:
measure: Lipids and lipoproteins
timeFrame: Change from baseline during the 4 hours after meal consumption
measure: Plasma Inflammatory cytokines
timeFrame: Change from baseline during the 4 hours after meal consumption
measure: Inflammatory cytokines in isolated peripheral blood mononuclear cells
timeFrame: Change from baseline during the 4 hours after meal consumption
measure: Glucose
timeFrame: Change from baseline during the 4 hours after meal consumption
measure: Insulin
timeFrame: Change from baseline during the 4 hours after meal consumption
measure: Plasma antioxidants (hydrophilic ORAC, lipophilic ORAC, total ORAC)
timeFrame: Change from baseline during the 4 hours after meal consumption
measure: Oxidative stress
timeFrame: Change from baseline during the 4 hours after meal consumption
measure: Plasma nitrite and nitrate
timeFrame: Change from baseline during the 4 hours after meal consumption
measure: Plasma and Urine Metabolomic profiling
timeFrame: Change from baseline during the 4 hours after meal consumption
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
References:
citation: 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.