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

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Inflammation; Cardiovascular Disease

Treatments: Other: Controlled feeding diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03064932

PKE SPICE

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 71 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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71 participants in 3 patient groups

SD-Low

Active Comparator group

Description:

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.

Treatment:

Other: Controlled feeding diet

SD-Mod

Experimental group

Description:

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.

Treatment:

Other: Controlled feeding diet

SD-Culinary

Experimental group

Description:

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.

Treatment:

Other: Controlled feeding diet