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The Acute Effect of Spices on Vascular Health

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Вход / Регистрация
Линкът е запазен в клипборда
СъстояниеЗавършен
Спонсори
Penn State University
Сътрудници
McCormick Science Institute

Ключови думи

Резюме

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.

Описание

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.

Дати

Последна проверка: 04/30/2019
Първо изпратено: 09/13/2016
Очаквано записване подадено: 02/20/2017
Първо публикувано: 02/26/2017
Изпратена последна актуализация: 05/13/2019
Последна актуализация публикувана: 05/15/2019
Действителна начална дата на проучването: 09/12/2016
Приблизителна дата на първично завършване: 03/28/2018
Очаквана дата на завършване на проучването: 03/28/2018

Състояние или заболяване

Oxidative Stress

Интервенция / лечение

Other: Herbs and spices

Other: High fat meal

Фаза

-

Групи за ръце

ArmИнтервенция / лечение
Active Comparator: Control
Consumption of a high fat meal (1000kcal, 45g fat)
Experimental: 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.
Experimental: 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.

Критерии за допустимост

Възрасти, отговарящи на условията за проучване 40 Years Да се 40 Years
Полове, допустими за проучванеMale
Приема здрави доброволциДа
Критерии

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

Резултат

Първични изходни мерки

1. Change in endothelial function measured by flow mediated dilation (FMD) of the brachial artery [Change from baseline at 2 hours and 4 hours after meal consumption]

Вторични изходни мерки

1. Lipids and lipoproteins [Change from baseline during the 4 hours after meal consumption]

2. Plasma Inflammatory cytokines [Change from baseline during the 4 hours after meal consumption]

3. Inflammatory cytokines in isolated peripheral blood mononuclear cells [Change from baseline during the 4 hours after meal consumption]

4. Glucose [Change from baseline during the 4 hours after meal consumption]

5. Insulin [Change from baseline during the 4 hours after meal consumption]

6. Plasma antioxidants (hydrophilic ORAC, lipophilic ORAC, total ORAC) [Change from baseline during the 4 hours after meal consumption]

7. Oxidative stress [Change from baseline during the 4 hours after meal consumption]

8. Plasma nitrite and nitrate [Change from baseline during the 4 hours after meal consumption]

9. Plasma and Urine Metabolomic profiling [Change from baseline during the 4 hours after meal consumption]

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