The Effect of Spice Consumption on Postprandial Vascular Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-25

Study Completion Date

2020-02-26

Brief Summary

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A 3-period randomized cross-over, controlled feeding study will be conducted to determine the effect of chronic spice consumption on postprandial vascular function. Participants will consume three test diets containing different amounts of spice. Each treatment period will last for 4 weeks. After each diet period a meal test will be conducted. Participants will consume a meal with a spice content corresponding to the diet period they have just completed. Endothelial function will be measured at 2 and 4 hours after meal consumption. Blood samples will also be taken during the 4 hours after meal consumption for measurement of lipids, immune and inflammatory markers.

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Detailed Description

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A 3-period randomized cross-over, controlled feeding study will be conducted to determine the effect of chronic spice consumption on postprandial vascular function, lipid levels, immune and inflammatory markers. Participants will consume three test diets containing different amounts of spice. Each treatment period will last for 4 weeks. At baseline and after each diet period a postprandial test will be conducted. Flow mediated dilation (FMD) will conducted in the fasting state and a catheter will be inserted for blood sampling. Participants will consume a control test meal containing low spice at baseline and after each diet period the test meal will contain a level of spice that corresponds to the amount of spice consumed during the diet period. Blood samples will be taken at 30, 60, 120, 180 and 240 minutes after meal consumption, and FMD will be performed at 120 and 240 minutes.

Conditions

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Cardiovascular Risk Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

3 period randomized cross over

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Person assessing the outcome measures will be blinded to participant allocation

Study Groups

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Low Spice

The test meal (\~1200kcal and 44g fat) will contain \~0.6g of spice blend

Group Type ACTIVE_COMPARATOR

Spice blend

Intervention Type OTHER

Test spices include cardamom, coriander, cumin, ginger, paprika, red pepper, turmeric, cinnamon

Moderate Spice

The test meal (\~1200kcal and 44g fat) will contain \~3.7g of spice blend

Group Type EXPERIMENTAL

Spice blend

Intervention Type OTHER

Test spices include cardamom, coriander, cumin, ginger, paprika, red pepper, turmeric, cinnamon

Culinary Spice

The test meal (\~1200kcal and 44g fat) will contain \~7.4g of spice blend

Group Type EXPERIMENTAL

Spice blend

Intervention Type OTHER

Test spices include cardamom, coriander, cumin, ginger, paprika, red pepper, turmeric, cinnamon

Interventions

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Spice blend

Test spices include cardamom, coriander, cumin, ginger, paprika, red pepper, turmeric, cinnamon

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Men and postmenopausal women Overweight or obese (25-35kg/m2) Non-smoking Waist circumference \>= 94cm for men and \>=80cm for women

At least one other of the following:

* LDL- cholesterol \>130mg/dL
* CRP \>1mg/L
* Triglycerides \>=150mg/dL
* HDL \<40mg/dL for men or \<50mg/dL for women
* Systolic blood pressure \>= 130mmHg or diastolic \>= 85mmHg
* Fasting glucose \>=100mg/dL

Exclusion Criteria

* Diabetes (fasting glucose \>126mg/dL)
* Hypertension (systolic blood pressure \>160mmHg or diastolic blood pressure \>100mmHg)
* Prescribed anti-hypertensive or glucose lowering drugs
* Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease
* Use of cholesterol/lipid lowering medication or supplementation (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals
* Pregnancy or lactation
* Weight loss of \>=10% of body weight within the 6 months prior to enrolling in the study
* Vegetarianism

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes