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

Not Applicable

Completed

• Conditions: Cardiovascular Disease; Inflammation
• Interventions: Other: Controlled feeding diet

• Registration Number: NCT03064932
• Lead Sponsor: Penn State University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2017-01-25
• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-27
• Primary Completion: 2020-02-26
• Study Completion: 2020-02-26
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SD-Mod	Controlled feeding diet	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.
SD-Culinary	Controlled feeding diet	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.
SD-Low	Controlled feeding diet	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.

Primary Outcome Measures

Name	Time	Method
Change in lipid/lipoprotein profile	Change from baseline in lipid/lipoprotein profile at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)	Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides

Secondary Outcome Measures

Name	Time	Method
Change in Glucose	Change from baseline in glucose at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Change in Insulin	Change from baseline in insulin at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
HDL function	Change from baseline in lipid/lipoprotein profile at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Diet satisfaction	After each 4 week diet period	Questionnaire
Change in flow mediated dilation	Change from baseline in flow mediated dilation at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)	Only to be completed on men and postmenopausal women
Change in lipoprotein particle size and subclasses	Change lipoprotein particle size and subclasses at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)	LDL, LDLR \[i.e., LDL-(IDL + Lp(a))\], Lp(a), IDL, HDL, HDL2, HDL3, VLDL, VLDL1+2, VLDL3, TC, TG, Non HDL, Remnant Lipoproteins, LDL4, LDL3, LDL2, ApoB100, ApoA1, ApoB100:A1.
Central blood pressure	Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Brachial blood pressure	Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Augmentation index	Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Pulse wave velocity	Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Inflammation and immune fuction	Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)	Serum: IL-1β, IL-6, IL-10, IL-12p70, interferon-gamma, monocyte chemoattractant protein-1, macrophage inflammatory protein-1alpha, TNF-alpha, vascular endothelial growth factor
Ambulatory blood pressure	Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
in vitro production of inflammatory cytokines and immune markers	Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)	effect of spice on in vitro production of TNF-alpha, IL-6,NF-κB, I-κB, MAP kinase, COX-2, iNOS from stimulated and unstimulated lipopolysaccharides in peripheral blood mononuclear cells. Activation status of macrophages.

Trial Locations

Locations (1)

Penn State University; 🇺🇸 University Park, Pennsylvania, United States