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NCT01076829 · ClinicalTrials.gov registry record · NA

Effects of a Spiced Meat Patty on Inflammation in Men With Type 2 Diabetes

A NA study of Type II Diabetes Mellitus, sponsored by University of California, Los Angeles.

Completed
Registry status
NA
Development phase
10
Enrollment target
1
Study location

NCT01076829 is a NA study of Type II Diabetes Mellitus that has completed, run by University of California, Los Angeles. The registered enrollment target is 10 participants, below the 173-participant average among 7 other Type II Diabetes Mellitus trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01076829, a NA study of Type II Diabetes Mellitus, has completed, sponsored by University of California, Los Angeles.

COMPLETED
Registry status
NA
Development phase
10 participants
Enrollment target
1
Study location

Study 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 flow-mediated dilation, nitric oxide, glucose, insulin, triglycerieds, oxidized LDL, and cytoxic lipid peroxidation products (MDA) levels in men with type 2 diabetes, 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 polyphenol-rich spices on postprandial levels of plasma oxidized LDL, triglycerides, insulin, glucose, and malondialdehyde (MDA). 2. To determine the effect of a ground beef patty meal with and without polyphenol-rich spices on postprandial levels of nitric oxide and flow-mediated dilation. 3. 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 lipotoxin MDA in males with type 2 diabetes mellitus.Men with diabetes mellitus type 2 have been selected for this study to enable assessment of markers of vascular health including nitric oxide in plasma and flow-mediated dilation. 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.

Conditions Studied

Interventions

  • OTHER Spice polyphenols

Study Locations (1)

California

  • David Geffen School of Medicine, UCLA Center for Human Nutrtiion - Los Angeles

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2009-07
Est. Completion 2014-06
Phase NA

What the Registry Record Tells You About NCT01076829

The ClinicalTrials.gov registry entry for NCT01076829 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 173-participant average among 7 other Type II Diabetes Mellitus trials with a reported enrollment target (94% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type II Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which Spice polyphenols is the first listed.

NCT01076829 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT01076829 about?

NCT01076829 is a clinical study titled "Effects of a Spiced Meat Patty on Inflammation in Men With Type 2 Diabetes". 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 t...

What is the current status of trial NCT01076829?

This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2009-07. Estimated completion is 2014-06.

What conditions does trial NCT01076829 study?

This clinical trial studies the following conditions: Type II Diabetes Mellitus.

What interventions are being tested in trial NCT01076829?

The interventions under investigation include: Spice polyphenols (OTHER).

Who is sponsoring clinical trial NCT01076829?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01076829 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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