Spices, Inflammation and Vascular Response in Humans

NCT03926442 | Completed

• 1 other identifier: IRB2019-014
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are:

1. 1.To characterize the time course of herbs/spice action on endothelial function as measured by FMD over 24 h using a challenge meal paradigm.
2. 2.To assess effects of herbs/spices on metabolic indices (ie., glucose, insulin), and inflammatory markers such as cytokines (ie., IL-6, TNF-alpha) and vascular adhesion molecules (ICAM and VCAM).

Conditions

Healthy

Keywords

Spices; Herbs; Metabolic responses; Endothelial function; Inflammatory markers

Outcome Measures

Primary Outcomes (1)

• Changes in postprandial endothelial function among 4 treatments measured in percent flow mediated dilation

  Vascular Assessments will be measured with Flow mediated vasodilation (FMD)

  Baseline to 24 hours

Secondary Outcomes (5)

• Changes in Plasma Interleukin-1 β (IL-1β) concentration response among 4 treatments.

  Baseline to 24 hours

• Changes in Plasma Interleukin-6 (IL-6) concentration response among 4 treatments.

  Baseline to 24 hours

• Changes in Plasma Tumor Necrosis Factor-α (TNF-α) concentration response among 4 treatments.

  Baseline to 24 hours

• Changes in Plasma intercellular adhesion molecule 1 (ICAM 1) concentration response among 4 treatments.

  Baseline to 24 hours

• Changes in Plasma vascular cell adhesion molecule 1 (VCAM 1) concentration response among 4 treatments.

  baseline to 24 hours

Study Arms (4)

Active1

EXPERIMENTAL

Italian Herb in active breakfast meal

Other: Italian Herb meal

Active2

EXPERIMENTAL

Cinnamon in active breakfast meal

Other: Cinnamon Meal

Active3

EXPERIMENTAL

Pumpkin Spice Mix in active breakfast meal

Other: Pumpkin Spice meal

Placebo Comparator

PLACEBO COMPARATOR

Placebo Breakfast

Other: Placebo meal

Interventions

Italian Herb meal OTHER

Italian Herb in active breakfast meal

Also known as: Italian Herb

Active1

Cinnamon Meal OTHER

Cinnamon in active breakfast meal

Also known as: Cinnamon

Active2

Pumpkin Spice meal OTHER

Pumpkin Spice Mix in active breakfast meal

Also known as: Pumpkin Spice Mix

Active3

Placebo meal OTHER

Placebo in breakfast meal

Also known as: Placebo

Placebo Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI between 25 and 35 kg/m2
• Aged 18 years and older
• Able to provide informed consent and comply with study procedures
• Willing to maintain stable body weight and follow his/her habitual diet and physical activity patterns throughout the trial.
• Judged by the Investigator to be in general good health on the basis of medical history and screening laboratory tests.
• People with no documented disease condition that would interfere with the study endpoints (ie., CVD, diabetes, hypertension, major organ diseases) or taking medication or dietary supplements that may interfere with study endpoints

You may not qualify if:

• Current smoker or marijuana user
• No history or presence of atherosclerosis/cardiovascular disease, inflammatory disease, diabetes mellitus, or other systemic diseases, psychological or psychiatric disorders that may interfere with study outcomes.
• Taking any medications and/or supplements that would interfere with outcomes of the study (i.e., lipid-lowering medications, anti-inflammatory drugs, etc)
• Unstable use of any medication/supplement, this could include marijuana used as -needed for medical reasons
• Have a history of cancer, except for non-melanoma skin cancer in past 5 years
• Addicted to drugs and/or alcohol (\>4 drinks/day)
• Have been exposed to any non-registered drug product within last 30 days.
• Working overnight (e.g. 3rd shift of overnight workers)
• Excessive exercisers or trained athletes
• Have allergies/intolerances to cinnamon, Italian herbs, etc.
• Extreme dietary habits (ie. vegetarian/vegan)
• Excessive coffee/tea drinker (\>4 cups/day)
• Actively losing weight/ trying to lose weight (unstable body weight fluctuations of \> 5 kg in 3 months)
• Donated blood within last 3 months
• Female who is pregnant, planning to be pregnant, breastfeeding

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Related Publications (2)

• Huang Y, Edirisinghe I, Burton-Freeman BM, Sandhu AK. Characterization and Pharmacokinetic Profile of Herbs and Spices' Phytochemicals over 24 h after Consumption in Overweight/Obese Adults. Mol Nutr Food Res. 2023 Jul;67(14):e2200785. doi: 10.1002/mnfr.202200785. Epub 2023 Jun 13.

  PMID: 37310415 DERIVED

• Huang Y, Tsai MF, Thorat RS, Xiao D, Zhang X, Sandhu AK, Edirisinghe I, Burton-Freeman BM. Endothelial Function and Postprandial Glucose Control in Response to Test-Meals Containing Herbs and Spices in Adults With Overweight/Obesity. Front Nutr. 2022 Feb 22;9:811433. doi: 10.3389/fnut.2022.811433. eCollection 2022.

  PMID: 35273988 DERIVED

Study Officials

• Britt Burton-Freeman, Ph.D

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: April 24, 2019
• Study Start: April 18, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

US (1)