Colorectal NeoplasmsNCT02599103
The Effects of Various Cooking Oils on Health Related Biomarkers in Healthy Subjects
A study testing Fat-free milkshake, Olive oil and Soybean oil in people with Colorectal Neoplasms, run by Academia Sinica, Taiwan.
Trial summary
Fats and oils play important roles in maintaining human nutrition and health through providing energy, essential fatty acids, and acting as modulators of many biological processes (signal transduction, immunity and inflammation). Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Fat-free milkshake, Olive oil and Soybean oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Sep 2015
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking, non-drinker, usual dietary intake
- BMI : 18.5~27 kg/m2
Who cannot join
- Over the past two weeks have suffered from acute illness.
- None of the subjects was taking any supplemental vitamins, antioxidants or medication at that time.
- Taking steroids or non-steroidal anti-inflammatory drug, such as Aspirin or Panadol in the past one week.
- Cancer or other severe diseases was diagnosed.
About this study
Fats and oils play important roles in maintaining human nutrition and health through providing energy, essential fatty acids, and acting as modulators of many biological processes (signal transduction, immunity and inflammation). Due to differences in the fatty acid composition and content of antioxidants of individual cooking oils, the degree of oxidative and thermolytic reactions may vary oil by oil. It is lack of human feeding study to investigate the molecular mechanisms on how and which deep-fried oil exerts its adverse effects. The investigators are also lack of biomarkers for monitoring deep-fried oil exposure. Therefore, the purpose of this study is to compare how human body responds differently to several popular uncooked and deep-fried oils with varied fatty acid compositions with respect of oxylipin profile, inflammatory markers, non-targeted metabolomics, and transcriptomics. The investigators will recruit 20 volunteers, provided them once a week the milk shakes prepared from 60g of olive oil, soybean oil, palm oil, camellia oil, tallow (butter), and deep-fried oils of the last 4, respectively; in comparison with a no-fat milk shake control. The experiments lasted for 10 weeks.。Each time; serum, plasma, whole blood and urine samples were collected at baseline, after 2 hours, and after 4 hours. The investigators anticipate to find biomarker(s) for deep-frying, and contribute to the understanding of molecular mechanisms on how deep-fried oils exert adverse effects toward health through integrative omics or so-called system biology approaches.
- Conditions
- Colorectal Neoplasms
- Being tested
- Fat-free milkshake, Olive oil, Soybean oil, Fried soybean oil, Palm oil
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat-free milkshakeOther
participants drinks a fat-free milk shakes
Olive oilOther
participants drinks the milk shakes prepared from 60g of olive oil
Soybean oilOther
participants drinks the milk shakes prepared from 60g of soybean oil
Fried soybean oilOther
participants drinks the milk shakes prepared from 60g of fried soybean oil
Palm oilOther
participants drinks the milk shakes prepared from 60g of palm oil
Fried palm oilOther
participants drinks the milk shakes prepared from 60g of fried palm oil
Camellia oilOther
participants drinks the milk shakes prepared from 60g of camellia oil
Fried camellia oilOther
participants drinks the milk shakes prepared from 60g of fried camellia oil
TallowOther
participants drinks the milk shakes prepared from 60g of tallow
Fried tallowOther
participants drinks the milk shakes prepared from 60g of fried tallow
| Study group | Role | What they receive |
|---|---|---|
| fat-free milkshake | Placebo comparator | Not described Receives: Other: Fat-free milkshake |
| Olive oil | Active comparator | Not described Receives: Other: Olive oil |
| soybean oil | Experimental | Not described Receives: Other: Soybean oil |
| fried soybean oil | Experimental | Not described Receives: Other: Fried soybean oil |
| palm oil | Experimental | Not described Receives: Other: Palm oil |
| fried palm oil | Experimental | Not described Receives: Other: Fried palm oil |
| camellia oil | Experimental | Not described Receives: Other: Camellia oil |
| fried camellia oil | Experimental | Not described Receives: Other: Fried camellia oil |
| tallow | Experimental | Not described Receives: Other: Tallow |
| fried tallow | Experimental | Not described Receives: Other: Fried tallow |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changs of metabolomics profile between before and after oil consumption
This is a metabolomics study. We measured retention time (min), mass and abundance of serum metabolites with LC-QTOF at 3 time points. Then, we compared the abundance of metabolites between different oil consumption time ( before and after ) and assessed the health effects of cooking oils.
Measured: baseline to 2 hours and 4 hours after oil consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startSep 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academia Sinica, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Harn Pan, Academia Sinica, Taiwan
- Investigators
- Wen-Harn Pan, Ph.D., Principal investigator, Institute of Biomedical Sciences, Academia Sinica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599103
- Sponsor's protocol ID
- AS-IRB02-102083
- Status last verified
- Oct 2015
- First submitted
- 15 Sep 2015
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Various Cooking Oils on Health Related Biomarkers in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02599103
- Acronym / sponsor ID
- AS-IRB02-102083
- Conditions
- Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Academia Sinica, TaiwanUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 6 Nov 2015 (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.
Fats and oils play important roles in maintaining human nutrition and health through providing energy, essential fatty acids, and acting as modulators of many biological processes (signal transduction, immunity and inflammation). Due to differences in the fatty acid composition and content of antioxidants of individual cooking oils, the degree of oxidative and thermolytic reactions may vary oil by oil. It is lack of human feeding study to investigate the molecular mechanisms on how and which deep-fried oil exerts its adverse effects. The investigators are also lack of biomarkers for monitoring deep-fried oil exposure. Therefore, the purpose of this study is to compare how human body responds differently to several popular uncooked and deep-fried oils with varied fatty acid compositions with respect of oxylipin profile, inflammatory markers, non-targeted metabolomics, and transcriptomics. The investigators will recruit 20 volunteers, provided them once a week the milk shakes prepared from 60g of olive oil, soybean oil, palm oil, camellia oil, tallow (butter), and deep-fried oils of the last 4, respectively; in comparison with a no-fat milk shake control. The experiments lasted for 10 weeks.。Each time; serum, plasma, whole blood and urine samples were collected at baseline, after 2 hours, and after 4 hours. The investigators anticipate to find biomarker(s) for deep-frying, and contribute to the understanding of molecular mechanisms on how deep-fried oils exert adverse effects toward health through integrative omics or so-called system biology approaches.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| fat-free milkshake | Placebo comparator | Other: Fat-free milkshake |
| Olive oil | Active comparator | Other: Olive oil |
| soybean oil | Experimental | Other: Soybean oil |
| fried soybean oil | Experimental | Other: Fried soybean oil |
| palm oil | Experimental | Other: Palm oil |
| fried palm oil | Experimental | Other: Fried palm oil |
| camellia oil | Experimental | Other: Camellia oil |
| fried camellia oil | Experimental | Other: Fried camellia oil |
| tallow | Experimental | Other: Tallow |
| fried tallow | Experimental | Other: Fried tallow |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Non-smoking, non-drinker, usual dietary intake
- BMI : 18.5~27 kg/m2
Key exclusion criteria (4 listed)
- Over the past two weeks have suffered from acute illness.
- None of the subjects was taking any supplemental vitamins, antioxidants or medication at that time.
- Taking steroids or non-steroidal anti-inflammatory drug, such as Aspirin or Panadol in the past one week.
- Cancer or other severe diseases was diagnosed.
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 |
|---|---|---|
| Fat-free milkshakeparticipants drinks a fat-free milk shakes | Other | fat-free milkshake |
| Olive oilparticipants drinks the milk shakes prepared from 60g of olive oil | Other | Olive oil |
| Soybean oilparticipants drinks the milk shakes prepared from 60g of soybean oil | Other | soybean oil |
| Fried soybean oilparticipants drinks the milk shakes prepared from 60g of fried soybean oil | Other | fried soybean oil |
| Palm oilparticipants drinks the milk shakes prepared from 60g of palm oil | Other | palm oil |
| Fried palm oilparticipants drinks the milk shakes prepared from 60g of fried palm oil | Other | fried palm oil |
| Camellia oilparticipants drinks the milk shakes prepared from 60g of camellia oil | Other | camellia oil |
| Fried camellia oilparticipants drinks the milk shakes prepared from 60g of fried camellia oil | Other | fried camellia oil |
| Tallowparticipants drinks the milk shakes prepared from 60g of tallow | Other | tallow |
| Fried tallowparticipants drinks the milk shakes prepared from 60g of fried tallow | Other | fried tallow |
Primary outcome
The changs of metabolomics profile between before and after oil consumption
Time frame: baseline to 2 hours and 4 hours after oil consumption
This is a metabolomics study. We measured retention time (min), mass and abundance of serum metabolites with LC-QTOF at 3 time points. Then, we compared the abundance of metabolites between different oil consumption time ( before and after ) and assessed the health effects of cooking oils.
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 6 Nov 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.
Wen-Harn Pan, Ph.D. principal investigator
Institute of Biomedical Sciences, Academia Sinica
Questions about this trial
What is this clinical trial studying?
A study testing Fat-free milkshake, Olive oil and Soybean oil in people with Colorectal Neoplasms, run by Academia Sinica, Taiwan.
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 2 inclusion and 4 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 6 Nov 2015. 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?
The changs of metabolomics profile between before and after oil consumption (time frame: baseline to 2 hours and 4 hours after oil consumption). 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 6 Nov 2015.