Oxidative StressNCT02006771
Cultural Meal and Postprandial Oxidative Stress
A study testing Southern Chinese meal, Northern Chinese meal and American meal in people with Oxidative Stress, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
This one-year randomized crossover study is proposed to compare the changes of postprandial oxidative stress (POS) after consumption of meals from different cultures in healthy Chinese adults, using a 'real-life, cultural meal' approach. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Southern Chinese meal, Northern Chinese meal and American meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 2014
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Apparently healthy male or female of Chinese ethnicity with BMI less than 25 kg/m2
- Aged from 18 to 45 years for female to avoid menopausal effect, and 18 to 50 years for male (inclusive)
- Normal glucose tolerance as assessed by fasting HbA1c of <6% at the screening
- Willing to give consent and follow the study procedures
Who cannot join
- Lifestyle factors that affect POS as shown by the literature including
- Current smoker
- Physically active as defined by three days or more of 30 minutes [accumulated over the course of a day] moderate to vigorous activity weekly in the past three months. Vigorous physical activity is described as causing heavy sweating or a large increase in breathing or heart rate, and moderate as causing light sweating or a slight to moderate increase in breathing or heart rate.
- Regular or current use of vitamin or antioxidant supplements
- Pregnant or lactating
- Concurrent participation in any clinical trial or dietary intervention program
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- Adherence to a special diet, allergies or aversions to foods on the study meals
- Use of medications that could affect study outcomes
- With diabetes, hypertension, renal, liver or thyroid dysfunction, any other indication of a major medical or psychological illness, as judged by the investigators as ineligible to participate the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Crossover Trial to Compare the Changes of Postprandial Oxidative Stress After Consumption of Meals From Different Cultures in Healthy Chinese Adults
This one-year randomized crossover study is proposed to compare the changes of postprandial oxidative stress (POS) after consumption of meals from different cultures in healthy Chinese adults, using a 'real-life, cultural meal' approach. It is hypothesized that the changes of POS differ with meals from different cultures. Four cultural meals are chosen, namely Southern Chinese, Northern Chinese, American, and South Indian, based on the known prevalence of chronic diseases between Caucasians, Chinese and Indians, and within the Southern and Northern Chinese population.
- Conditions
- Oxidative Stress
- Being tested
- Southern Chinese meal, Northern Chinese meal, American meal, South Indian meal
- Keywords
- Meal, Postprandial oxidative stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Southern Chinese mealOther
White rice (1 bowl), stir fried choi sum (0.5 bowl) and stir fried lean pork (0.5 bowl) cooked with maize oil
Northern Chinese mealOther
Noodles (1 bowl) and shredded pork with sweet bean sauce (0.5 bowl) cooked with blend oil
American mealOther
Hamburger with cheese (1 piece), French fries (117 g) cooked with canola blend oil and Coca-cola classic (21 fluid ounces)
South Indian mealOther
Basmati rice (1 bowl), chicken curry dish (0.5 bowl), dry vegetable dish (i.e. green beans mixed with herbs) (0.5 bowl), yogurt made with milk powder mainly (0.5 bowl), pickle made with lemon, salt, chilli powder, Asafoetida and vegetable based oil (1 tablespoon)
| Study group | Role | What they receive |
|---|---|---|
| Southern Chinese meal | Experimental | White rice (1 bowl), stir fried Choi sum (0.5 bowl) and stir fried lean pork (0.5 bowl) cooked with maize oil Receives: Other: Southern Chinese meal |
| Northern Chinese meal | Experimental | Noodles (1 bowl) and shredded pork with sweet bean sauce (0.5 bowl) cooked with blend oil Receives: Other: Northern Chinese meal |
| American meal | Experimental | Hamburger with cheese (1 piece), French fries (117 g) cooked with canola blend oil plus Coca-cola classic (21 fluid ounces) Receives: Other: American meal |
| South Indian meal | Experimental | Basmati rice (1 bowl), chicken curry dish (0.5 bowl), dry vegetable dish (i.e. green beans mixed with herbs) (0.5 bowl), yogurt made with milk powder mainly (0.5 bowl), pickle made with lemon, salt, chilli powder, Asafoetida and vegetable based oil (1 tablespoon) Receives: Other: South Indian meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of plasma allantoin from 0 (pre-meal) to 6 hours post-meal
Measured: pre-meal (0 hour), 2, 4, 6 hours post-meal
Secondary outcomes (1)
Change of urine F2-isoprostanes from 0 (pre-meal) to 6 hours post-meal
Measured: pre-meal (0 hour), 2, 4, 6 hours post-meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Chan, Chinese University of Hong Kong
- Investigators
- Ruth Chan, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006771
- Sponsor's protocol ID
- 461813
- Other IDs
- 461813
- Status last verified
- Jan 2015
- First submitted
- 28 Nov 2013
- Last updated
- 7 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Trial to Compare the Changes of Postprandial Oxidative Stress After Consumption of Meals From Different Cultures in Healthy Chinese Adults
- ClinicalTrials.gov ID
- NCT02006771
- Acronym / sponsor ID
- 461813
- Conditions
- Oxidative Stress
- Keywords
- Meal, Postprandial oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Dec 2013 (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.
This one-year randomized crossover study is proposed to compare the changes of postprandial oxidative stress (POS) after consumption of meals from different cultures in healthy Chinese adults, using a 'real-life, cultural meal' approach. It is hypothesized that the changes of POS differ with meals from different cultures. Four cultural meals are chosen, namely Southern Chinese, Northern Chinese, American, and South Indian, based on the known prevalence of chronic diseases between Caucasians, Chinese and Indians, and within the Southern and Northern Chinese population.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Southern Chinese meal | Experimental | Other: Southern Chinese mealWhite rice (1 bowl), stir fried Choi sum (0.5 bowl) and stir fried lean pork (0.5 bowl) cooked with maize oil |
| Northern Chinese meal | Experimental | Other: Northern Chinese mealNoodles (1 bowl) and shredded pork with sweet bean sauce (0.5 bowl) cooked with blend oil |
| American meal | Experimental | Other: American mealHamburger with cheese (1 piece), French fries (117 g) cooked with canola blend oil plus Coca-cola classic (21 fluid ounces) |
| South Indian meal | Experimental | Other: South Indian mealBasmati rice (1 bowl), chicken curry dish (0.5 bowl), dry vegetable dish (i.e. green beans mixed with herbs) (0.5 bowl), yogurt made with milk powder mainly (0.5 bowl), pickle made with lemon, salt, chilli powder, Asafoetida and vegetable based oil (1 tablespoon) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Apparently healthy male or female of Chinese ethnicity with BMI less than 25 kg/m2
- Aged from 18 to 45 years for female to avoid menopausal effect, and 18 to 50 years for male (inclusive)
- Normal glucose tolerance as assessed by fasting HbA1c of <6% at the screening
- Willing to give consent and follow the study procedures
Key exclusion criteria (9 listed)
- Lifestyle factors that affect POS as shown by the literature including
- Current smoker
- Physically active as defined by three days or more of 30 minutes [accumulated over the course of a day] moderate to vigorous activity weekly in the past three months. Vigorous physical activity is described as causing heavy sweating or a large increase in breathing or heart rate, and moderate as causing light sweating or a slight to moderate increase in breathing or heart rate.
- Regular or current use of vitamin or antioxidant supplements
- Pregnant or lactating
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 |
|---|---|---|
| Southern Chinese mealWhite rice (1 bowl), stir fried choi sum (0.5 bowl) and stir fried lean pork (0.5 bowl) cooked with maize oil | Other | Southern Chinese meal |
| Northern Chinese mealNoodles (1 bowl) and shredded pork with sweet bean sauce (0.5 bowl) cooked with blend oil | Other | Northern Chinese meal |
| American mealHamburger with cheese (1 piece), French fries (117 g) cooked with canola blend oil and Coca-cola classic (21 fluid ounces) | Other | American meal |
| South Indian mealBasmati rice (1 bowl), chicken curry dish (0.5 bowl), dry vegetable dish (i.e. green beans mixed with herbs) (0.5 bowl), yogurt made with milk powder mainly (0.5 bowl), pickle made with lemon, salt, chilli powder, Asafoetida and vegetable based oil (1 tablespoon) | Other | South Indian meal |
Primary outcome
Change of plasma allantoin from 0 (pre-meal) to 6 hours post-meal
Time frame: pre-meal (0 hour), 2, 4, 6 hours post-meal
1 secondary outcome
Change of urine F2-isoprostanes from 0 (pre-meal) to 6 hours post-meal
Time frame: pre-meal (0 hour), 2, 4, 6 hours post-meal
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 7 Jan 2015.
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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.
Ruth Chan, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Southern Chinese meal, Northern Chinese meal and American meal in people with Oxidative Stress, run by Chinese University of Hong Kong at 1 site in China.
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 4 inclusion and 9 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 7 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 of plasma allantoin from 0 (pre-meal) to 6 hours post-meal (time frame: pre-meal (0 hour), 2, 4, 6 hours post-meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2015.