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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01027052
Other study ID # 08-03-008-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2008
Est. completion date May 2009

Study information

Verified date October 2018
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. To determine the effect of a ground beef patty meal with and without spices on postprandial levels of plasma malondialdehyde (MDA).

2. To determine the effect of a ground beef patty meal with and without a spice blend on MDA accumulation in urine.

This study will determine whether spice polyphenols exert a beneficial effect by inhibition of the absorption of MDA. These findings may help to explain the potentially harmful effects of oxidizable fats found in foods and the important benefit of dietary polyphenols in ameliorating this potentially harmful effect.


Description:

10 male subjects with type 2 diabetes mellitus who will be recruited based on inclusion and exclusion criteria. The study will be carried out in accordance with the guidelines of the Human Subjects Protection Committee of the University of California, Los Angeles. All subjects will give written informed consent before the study begins. After the screening visit, each subject will come to the Center for Human Nutrition on two 1-day test phases separated by at least one week. At each of phases, subjects will consume, in a random order, two different test meals consisting of either: a) a ground dark meat beef patty seasoned with salt only, or b) a ground dark meat beef patty seasoned with a spice mixture and salt. The subjects will be asked to avoid eating meat, poultry, or fish products for 3 days before the day of each of the two experimental phases


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date May 2009
Est. primary completion date October 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Hamburger meat patty with salt
hamburger meat cooked with salt
Hamburger meat patty with spice blend
hamburger meat cooked with spice mixture

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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