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

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fat-free milkshake
Olive oil
Soybean oil
Fried soybean oil
Palm oil
Fried palm oil
Camellia oil
Fried camellia oil
Tallow
Fried tallow
Sponsored by
Academia Sinica, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Colorectal Neoplasms

Eligibility Criteria

20 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm 10

    Arm Type

    Placebo Comparator

    Active Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    fat-free milkshake

    Olive oil

    soybean oil

    fried soybean oil

    palm oil

    fried palm oil

    camellia oil

    fried camellia oil

    tallow

    fried tallow

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 15, 2015
    Last Updated
    November 5, 2015
    Sponsor
    Academia Sinica, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02599103
    Brief Title
    The Effects of Various Cooking Oils on Health Related Biomarkers in Healthy Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Academia Sinica, Taiwan

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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). 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Neoplasms

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Non-Randomized
    Enrollment
    17 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    fat-free milkshake
    Arm Type
    Placebo Comparator
    Arm Title
    Olive oil
    Arm Type
    Active Comparator
    Arm Title
    soybean oil
    Arm Type
    Experimental
    Arm Title
    fried soybean oil
    Arm Type
    Experimental
    Arm Title
    palm oil
    Arm Type
    Experimental
    Arm Title
    fried palm oil
    Arm Type
    Experimental
    Arm Title
    camellia oil
    Arm Type
    Experimental
    Arm Title
    fried camellia oil
    Arm Type
    Experimental
    Arm Title
    tallow
    Arm Type
    Experimental
    Arm Title
    fried tallow
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Fat-free milkshake
    Intervention Description
    participants drinks a fat-free milk shakes
    Intervention Type
    Other
    Intervention Name(s)
    Olive oil
    Intervention Description
    participants drinks the milk shakes prepared from 60g of olive oil
    Intervention Type
    Other
    Intervention Name(s)
    Soybean oil
    Intervention Description
    participants drinks the milk shakes prepared from 60g of soybean oil
    Intervention Type
    Other
    Intervention Name(s)
    Fried soybean oil
    Intervention Description
    participants drinks the milk shakes prepared from 60g of fried soybean oil
    Intervention Type
    Other
    Intervention Name(s)
    Palm oil
    Intervention Description
    participants drinks the milk shakes prepared from 60g of palm oil
    Intervention Type
    Other
    Intervention Name(s)
    Fried palm oil
    Intervention Description
    participants drinks the milk shakes prepared from 60g of fried palm oil
    Intervention Type
    Other
    Intervention Name(s)
    Camellia oil
    Intervention Description
    participants drinks the milk shakes prepared from 60g of camellia oil
    Intervention Type
    Other
    Intervention Name(s)
    Fried camellia oil
    Intervention Description
    participants drinks the milk shakes prepared from 60g of fried camellia oil
    Intervention Type
    Other
    Intervention Name(s)
    Tallow
    Intervention Description
    participants drinks the milk shakes prepared from 60g of tallow
    Intervention Type
    Other
    Intervention Name(s)
    Fried tallow
    Intervention Description
    participants drinks the milk shakes prepared from 60g of fried tallow
    Primary Outcome Measure Information:
    Title
    The changs of metabolomics profile between before and after oil consumption
    Description
    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.
    Time Frame
    baseline to 2 hours and 4 hours after oil consumption

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Non-smoking, non-drinker, usual dietary intake BMI : 18.5~27 kg/m2 Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wen-Harn Pan, Ph.D.
    Organizational Affiliation
    Institute of Biomedical Sciences, Academia Sinica
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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