Effect of a Spice Blend on Cardiovascular Risk Factors and Diet Satisfaction

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

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-25

Study Completion Date

2020-02-26

Brief Summary

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This study is a randomized 3-period crossover, controlled feeding study designed to evaluate the effects of the most commonly consumed spices in the U.S. on CVD risk factors, inflammation \& immune function, and diet satisfaction in participants at risk for CVD.

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Detailed Description

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A 3-period randomized crossover controlled-feeding study will be conducted. Participants will be randomly assigned to receive each 4-week treatment (diet) in random order. Each test diet period will be separated by a standard 4-week compliance break. Data collection will be conducted across at baseline (start of study) and the end of each diet period to assess the effects of chronic spice consumption on selected cardiovascular endpoints.

Conditions

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Cardiovascular Disease Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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SD-Low

Average American Diet (32% of calories from fat, 11% of calories from saturated fat and 3400mg sodium/day) with a minimal amount of spices (\<1g/day for all diets).

Post prandial test meal will be contain minimal amounts of spice.

Group Type ACTIVE_COMPARATOR

Controlled feeding diet

Intervention Type OTHER

Average American diet with different levels of spices

SD-Mod

Average American Diet (32% of calories from fat, 11% of calories from saturated fat and 3400mg sodium/day) with a moderate amount of spices (\~3g/day in the 2100kcal diet).

Post prandial test meal will be contain a moderate amount of spice.

Group Type EXPERIMENTAL

Controlled feeding diet

Intervention Type OTHER

Average American diet with different levels of spices

SD-Culinary

Average American Diet (32% of calories from fat, 11% of calories from saturated fat and 3400mg sodium/day) with a culinary dose of spices (6g/day in the 2100kcal diet).

Post prandial test meal will be contain a culinary amount of spice.

Group Type EXPERIMENTAL

Controlled feeding diet

Intervention Type OTHER

Average American diet with different levels of spices

Interventions

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Controlled feeding diet

Average American diet with different levels of spices

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* overweight or obese (25-35kg/m2)
* non-smoking
* male or female
* 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