An interventional study of Herbs and spices and High fat meal in Oxidative Stress, sponsored by Penn State University. Completed at 1 site in United States. Open to male participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Penn State University · Not applicable, Interventional, and Prevention
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.
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.
Penn State University is the lead sponsor of 263 studies on the registry; 51 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.
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Exclusion Criteria:
Consumption of a high fat meal (1000kcal, 45g fat)
Other: High fat meal
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.
Other: Herbs and spices · Other: High fat meal
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.
Other: Herbs and spices · Other: High fat meal
Mix of commonly used herbs and spices
Meal containing 1000kcal and 45g fat
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
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
Plan to share: No
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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