NCT03064932

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2020

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

3.1 years

First QC Date

February 13, 2017

Last Update Submit

August 15, 2023

Conditions

Cardiovascular DiseaseInflammation

Outcome Measures

Primary Outcomes (1)

  • Change in lipid/lipoprotein profile

    Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides

    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)

Secondary Outcomes (13)

  • 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)

  • 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)

  • +8 more secondary outcomes

Other Outcomes (3)

  • Change in LDL oxidation

    Change from baseline in LDL oxidation at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)

  • Change in composition of the gut microbiome

    Change from baseline in composition of the gut microbiome at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)

  • Change in urinary isoprostanes

    Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)

Study Arms (3)

SD-Low

ACTIVE COMPARATOR

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.

Other: Controlled feeding diet

SD-Mod

EXPERIMENTAL

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.

Other: Controlled feeding diet

SD-Culinary

EXPERIMENTAL

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.

Other: Controlled feeding diet

Interventions

Controlled feeding dietOTHER

Average American diet with different levels of spices

SD-CulinarySD-LowSD-Mod

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (3)

  • Petersen KS, Anderson S, Chen See JR, Leister J, Kris-Etherton PM, Lamendella R. Herbs and Spices Modulate Gut Bacterial Composition in Adults at Risk for CVD: Results of a Prespecified Exploratory Analysis from a Randomized, Crossover, Controlled-Feeding Study. J Nutr. 2022 Nov;152(11):2461-2470. doi: 10.1093/jn/nxac201. Epub 2022 Sep 2.

    PMID: 36774112DERIVED

  • Oh ES, Petersen KS, Kris-Etherton PM, Rogers CJ. Four weeks of spice consumption lowers plasma proinflammatory cytokines and alters the function of monocytes in adults at risk of cardiometabolic disease: secondary outcome analysis in a 3-period, randomized, crossover, controlled feeding trial. Am J Clin Nutr. 2022 Jan 11;115(1):61-72. doi: 10.1093/ajcn/nqab331.

    PMID: 34601551DERIVED

  • Petersen KS, Davis KM, Rogers CJ, Proctor DN, West SG, Kris-Etherton PM. Herbs and spices at a relatively high culinary dosage improves 24-hour ambulatory blood pressure in adults at risk of cardiometabolic diseases: a randomized, crossover, controlled-feeding study. Am J Clin Nutr. 2021 Dec 1;114(6):1936-1948. doi: 10.1093/ajcn/nqab291.

    PMID: 34510174DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesInflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Penny Kris-Etherton, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 27, 2017

Study Start

January 25, 2017

Primary Completion

February 26, 2020

Study Completion

February 26, 2020

Last Updated

August 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)