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The Acute Effect of Spices on Vascular Health

The Postprandial Effects of a High Fat Meal Containing Spices on Endothelial Function: a Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03064958
Enrollment
13
Registered
2017-02-27
Start date
2016-09-13
Completion date
2018-03-29
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxidative Stress

Keywords

glucose regulation, lipids, Immune markers, Endothelium, Vascular

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.

Interventions

OTHERHerbs and spices

Mix of commonly used herbs and spices

Meal containing 1000kcal and 45g fat

Sponsors

McCormick Science Institute
CollaboratorINDUSTRY
Penn State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
40 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Change in endothelial function measured by flow mediated dilation (FMD) of the brachial arteryChange from baseline at 2 hours and 4 hours after meal consumption

Secondary

MeasureTime frame
Plasma and Urine Metabolomic profilingChange from baseline during the 4 hours after meal consumption
Lipids and lipoproteinsChange from baseline during the 4 hours after meal consumption
Plasma Inflammatory cytokinesChange from baseline during the 4 hours after meal consumption
Inflammatory cytokines in isolated peripheral blood mononuclear cellsChange from baseline during the 4 hours after meal consumption
Plasma nitrite and nitrateChange from baseline during the 4 hours after meal consumption
InsulinChange from baseline during the 4 hours after meal consumption
Plasma antioxidants (hydrophilic ORAC, lipophilic ORAC, total ORAC)Change from baseline during the 4 hours after meal consumption
Oxidative stressChange from baseline during the 4 hours after meal consumption
GlucoseChange from baseline during the 4 hours after meal consumption

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026