NCT03064958

Brief Summary

The investigators aim to conduct a 3-period randomized controlled crossover study to investigate the postprandial effects of a high fat meal with spice on endothelial function, lipids/lipoproteins, immune function and plasma markers of antioxidants and oxidative stress. Metabolomic profiling will also be conducted. In random order, participants will consume either a high fat meal (1000kcal, 45g fat) or a high fat meal containing 2g of spice or a high fat meal containing 6g of spice. Between each treatment there will be a washout period of at least 3 days. It is hypothesized that consumption of a high fat meal with spice will attenuate postprandial endothelial impairment and triglyceride levels in a dose response manner compared with a high fat meal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

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

September 13, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 14, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2018

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

1.5 years

First QC Date

September 14, 2016

Last Update Submit

August 16, 2023

Conditions

Oxidative Stress

Keywords

glucose regulationlipidsImmune markersEndothelium, Vascular

Outcome Measures

Primary Outcomes (1)

  • Change in endothelial function measured by flow mediated dilation (FMD) of the brachial artery

    Change from baseline at 2 hours and 4 hours after meal consumption

Secondary Outcomes (9)

  • Lipids and lipoproteins

    Change from baseline during the 4 hours after meal consumption

  • Plasma Inflammatory cytokines

    Change from baseline during the 4 hours after meal consumption

  • Inflammatory cytokines in isolated peripheral blood mononuclear cells

    Change from baseline during the 4 hours after meal consumption

  • Glucose

    Change from baseline during the 4 hours after meal consumption

  • Insulin

    Change from baseline during the 4 hours after meal consumption

  • +4 more secondary outcomes

Study Arms (3)

Control

ACTIVE COMPARATOR

Consumption of a high fat meal (1000kcal, 45g fat)

Other: High fat meal

Spice 2g

EXPERIMENTAL

Consumption of a high fat meal (1000kcal, 45g fat) with 2g of spice (mix of black pepper, basil, bay leaf, cinnamon, coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme) incorporated into the meal.

Other: Herbs and spicesOther: High fat meal

Spice 6g

EXPERIMENTAL

Consumption of a high fat meal (1000kcal, 45g fat) with 6g of spice (mix of black pepper, basil, bay leaf, cinnamon, coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme) incorporated into the meal.

Other: Herbs and spicesOther: High fat meal

Interventions

Herbs and spicesOTHER

Mix of commonly used herbs and spices

Spice 2gSpice 6g
High fat mealOTHER

Meal containing 1000kcal and 45g fat

ControlSpice 2gSpice 6g

Eligibility Criteria

Age40 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male aged 40-65 years
  • BMI 25-35kg/m2
  • nonsmoking
  • waist circumference =/\> 94cm and at least one other CVD risk factor (elevated LDL-C (\> 130 mg/dL), CRP (\> 1 mg/L), elevated Triglycerides (≥ 150 mg/dL), reduced HDL-cholesterol (\< 40 mg/dL), elevated blood pressure (systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg), elevated fasting glucose (≥ 100 mg/dL))
  • low herb/spice consumers (consumption \<1/day)

You may not qualify if:

  • Chronic disease risk factors that are diagnostic of diabetes (fasting glucose \> 126 mg/dL) or hypertension (SBP \>160 mm Hg or DBP \> 100 mm Hg).
  • Prescription of anti-hypertensive or glucose lowering drugs.
  • Established CVD, stroke, diabetes, liver, kidney or autoimmune disease
  • Use of cholesterol/lipid-lowering medication or supplements (psyllium, fish oil, soy lecithin, and phytoestrogens) and botanicals
  • 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 (1)

  • Oh ES, Petersen KS, Kris-Etherton PM, Rogers CJ. Spices in a High-Saturated-Fat, High-Carbohydrate Meal Reduce Postprandial Proinflammatory Cytokine Secretion in Men with Overweight or Obesity: A 3-Period, Crossover, Randomized Controlled Trial. J Nutr. 2020 Jun 1;150(6):1600-1609. doi: 10.1093/jn/nxaa063.

    PMID: 32211803DERIVED

MeSH Terms

Interventions

Spices

Intervention Hierarchy (Ancestors)

CondimentsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

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

Study Record Dates

First Submitted

September 14, 2016

First Posted

February 27, 2017

Study Start

September 13, 2016

Primary Completion

March 29, 2018

Study Completion

March 29, 2018

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)