NCT01027052

Brief Summary

Polyphenols belong to the largest group of secondary metabolites produced by plants, mainly, in response to biotic or abiotic stresses such as infections, wounding, UV irradiation, exposure to ozone, pollutants, and other hostile environmental conditions. It is thought that the molecular basis for the protective action of polyphenols in plants is their antioxidant and free radical scavenging properties. These numerous phenolic compounds are major biologically active components of spices, aromas, essential oils, and traditional medicines. In order to investigate the impact of spice polyphenols on postprandial cytotoxic lipid peroxidation products (MDA) levels in humans, the investigators propose to achieve the following specific aims using a randomized crossover study design:

  1. 1.To determine the effect of a ground beef patty meal with and without spices on postprandial levels of plasma malondialdehyde (MDA).
  2. 2.To determine the effect of a ground beef patty meal with and without a spice blend on MDA accumulation in urine.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

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

June 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2009

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 7, 2009

Completed
Last Updated

October 26, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

August 13, 2009

Last Update Submit

October 24, 2018

Conditions

Keywords

MDASpice

Outcome Measures

Primary Outcomes (1)

  • Change in plasma and urinary MDA after consumption of hamburg with or without spice mixture added

    Change in plasma and urinary MDA after consumption of 250 g hamburg meat with 11.3 g spice mixture added or without spice

    2 days

Study Arms (2)

Hamburger meat patty with Spice Blend

ACTIVE COMPARATOR

Hamburger meat patty containing spice blend will be consumed on 3 separate occasions

Other: Hamburger meat patty with spice blend

Hamburger meat patty with salt

PLACEBO COMPARATOR

Hamburger meat patty containing salt will be consumed on 3 separate occasions

Other: Hamburger meat patty with salt

Interventions

hamburger meat cooked with salt

Hamburger meat patty with salt

hamburger meat cooked with spice mixture

Hamburger meat patty with Spice Blend

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female, 20-45 years of age
  • Non-smokers, or smoke \< 1 cigarette per day
  • Not exercising heavily (\< 4 x 30 minutes aerobic exercise per week)
  • Willing to maintain normal activity and eating patterns for the duration of the study
  • Willing to avoid meat, fish or poultry for three days on two occasions prior to the test procedure
  • Consuming less than two alcoholic drinks per day
  • Not taking dietary supplements
  • No known allergy to beef, cloves, cinnamon, oregano, turmeric, cumin, rosemary, sage, red pepper, ginger, black pepper, paprika or garlic

You may not qualify if:

  • Metabolic disorders
  • Taking dietary supplements
  • Smoking \>1 cigarette/day
  • Exercising heavily (\>4x30 min of aerobic exercise/wk)
  • Drinking more than 2 glasses of wine, 2 cocktails or two beers /day.
  • Allergic to beef, cloves, cinnamon, oregano, turmeric, cumin, rosemary, sage, red pepper, ginger, black pepper, paprika or garlic
  • Known HIV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Li Z, Henning SM, Zhang Y, Zerlin A, Li L, Gao K, Lee RP, Karp H, Thames G, Bowerman S, Heber D. Antioxidant-rich spice added to hamburger meat during cooking results in reduced meat, plasma, and urine malondialdehyde concentrations. Am J Clin Nutr. 2010 May;91(5):1180-4. doi: 10.3945/ajcn.2009.28526. Epub 2010 Mar 24.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Salts

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

  • Zhaoping Li, MD, PhD

    David Geffen School of Medicine, UCLA Center for Human Nutrtiion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

August 13, 2009

First Posted

December 7, 2009

Study Start

June 1, 2008

Primary Completion

October 1, 2008

Study Completion

May 1, 2009

Last Updated

October 26, 2018

Record last verified: 2018-10