The Effects of Various Cooking Oils on Health Related Biomarkers in Healthy Subjects

November 5, 2015 updated by: Wen-Harn Pan, Academia Sinica, Taiwan
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 Overview

Status

Status

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Completed

Conditions

Conditions

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Intervention / Treatment

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Study Type

Study Type

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Interventional

Enrollment (Actual)

Enrollment

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17

Phase

Phase

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  • Not Applicable

Participation Criteria

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Eligibility Criteria

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Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Non-smoking, non-drinker, usual dietary intake
  • BMI : 18.5~27 kg/m2

Exclusion Criteria:

  1. Over the past two weeks have suffered from acute illness.
  2. None of the subjects was taking any supplemental vitamins, antioxidants or medication at that time.
  3. Taking steroids or non-steroidal anti-inflammatory drug, such as Aspirin or Panadol in the past one week.
  4. Cancer or other severe diseases was diagnosed.

Study Plan

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How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: fat-free milkshake
Other: Fat-free milkshake
participants drinks a fat-free milk shakes
Active Comparator: Olive oil
Other: Olive oil
participants drinks the milk shakes prepared from 60g of olive oil
Experimental: soybean oil
Other: Soybean oil
participants drinks the milk shakes prepared from 60g of soybean oil
Experimental: fried soybean oil
Other: Fried soybean oil
participants drinks the milk shakes prepared from 60g of fried soybean oil
Experimental: palm oil
Other: Palm oil
participants drinks the milk shakes prepared from 60g of palm oil
Experimental: fried palm oil
Other: Fried palm oil
participants drinks the milk shakes prepared from 60g of fried palm oil
Experimental: camellia oil
Other: Camellia oil
participants drinks the milk shakes prepared from 60g of camellia oil
Experimental: fried camellia oil
Other: Fried camellia oil
participants drinks the milk shakes prepared from 60g of fried camellia oil
Experimental: tallow
Other: Tallow
participants drinks the milk shakes prepared from 60g of tallow
Experimental: fried tallow
Other: Fried tallow
participants drinks the milk shakes prepared from 60g of fried tallow

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline to 2 hours and 4 hours after oil consumption

Collaborators and Investigators

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Sponsor

Sponsor

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Academia Sinica, Taiwan

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AS-IRB02-102083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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