NIDDMNCT01027052
Spices Inhibit the Formation and Absorption of Malondialdehyde From Hamburger Meat
A study testing Hamburger meat patty with salt and Hamburger meat patty with spice blend in people with NIDDM, run by University of California, Los Angeles.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- NIDDM
- What is being tested?
- Hamburger meat patty with salt and Hamburger meat patty with spice blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Absorption, Metabolism and Antioxidant Effects of Common Herbs
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:
- To determine the effect of a ground beef patty meal with and without spices on postprandial levels of plasma malondialdehyde (MDA).
- 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.
Read the detailed 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
- Conditions
- NIDDM
- Being tested
- Hamburger meat patty with salt, Hamburger meat patty with spice blend
- Keywords
- MDA, Spice
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hamburger meat patty with saltOther
hamburger meat cooked with salt
Hamburger meat patty with spice blendOther
hamburger meat cooked with spice mixture
| Study group | Role | What they receive |
|---|---|---|
| Hamburger meat patty with Spice Blend | Active comparator | Hamburger meat patty containing spice blend will be consumed on 3 separate occasions Receives: 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 Receives: Other: Hamburger meat patty with salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2009 (estimated)
- Study startJun 2008
- Primary completionOct 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NIDDMStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- Zhaoping Li, MD, PhD, Principal investigator, David Geffen School of Medicine, UCLA Center for Human Nutrtiion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027052
- Sponsor's protocol ID
- 08-03-008-01
- Status last verified
- Oct 2018
- First submitted
- 13 Aug 2009
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20335545
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption, Metabolism and Antioxidant Effects of Common Herbs
- ClinicalTrials.gov ID
- NCT01027052
- Acronym / sponsor ID
- 08-03-008-01
- Conditions
- NIDDM
- Keywords
- MDA, Spice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 7 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the effect of a ground beef patty meal with and without spices on postprandial levels of plasma malondialdehyde (MDA).
- 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.
Detailed 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hamburger meat patty with Spice Blend | Active comparator | Other: Hamburger meat patty with spice blendHamburger meat patty containing spice blend will be consumed on 3 separate occasions |
| Hamburger meat patty with salt | Placebo comparator | Other: Hamburger meat patty with saltHamburger meat patty containing salt will be consumed on 3 separate occasions |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hamburger meat patty with salthamburger meat cooked with salt | Other | Hamburger meat patty with salt |
| Hamburger meat patty with spice blendhamburger meat cooked with spice mixture | Other | Hamburger meat patty with Spice Blend |
Primary outcome
Change in plasma and urinary MDA after consumption of hamburg with or without spice mixture added
Time frame: 2 days
Change in plasma and urinary MDA after consumption of 250 g hamburg meat with 11.3 g spice mixture added or without spice
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Derived from this study: PubMed 20335545Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoping Li, MD, PhD principal investigator
David Geffen School of Medicine, UCLA Center for Human Nutrtiion
Questions about this trial
What is this clinical trial studying?
A study testing Hamburger meat patty with salt and Hamburger meat patty with spice blend in people with NIDDM, run by University of California, Los Angeles.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma and urinary MDA after consumption of hamburg with or without spice mixture added (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01027052, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2018.