The Acute Effect of Spices on Vascular Health

NCT ID: NCT03064958

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-13
• Study Completion Date: 2018-03-29

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.

Conditions

Oxidative Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control

Consumption of a high fat meal (1000kcal, 45g fat)

Group Type: ACTIVE_COMPARATOR

High fat meal

Intervention Type: OTHER

Meal containing 1000kcal and 45g fat

Spice 2g

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.

Group Type: EXPERIMENTAL

Herbs and spices

Intervention Type: OTHER

Mix of commonly used herbs and spices

High fat meal

Intervention Type: OTHER

Meal containing 1000kcal and 45g fat

Spice 6g

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.

Group Type: EXPERIMENTAL

Herbs and spices

Intervention Type: OTHER

Mix of commonly used herbs and spices

High fat meal

Intervention Type: OTHER

Meal containing 1000kcal and 45g fat

Interventions

Herbs and spices

Mix of commonly used herbs and spices

Intervention Type: OTHER

High fat meal

Meal containing 1000kcal and 45g fat

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

McCormick Science Institute

INDUSTRY

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Penn State University

University Park, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32211803 (View on PubMed)

Other Identifiers

PKE SPICE PILOT

Identifier Type: -

Identifier Source: org_study_id