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
About this trial
This is an interventional basic science trial for Colorectal Neoplasms
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.
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
NCT ID
NCT02599103
First Posted
September 15, 2015
Last Updated
November 5, 2015
Sponsor
Academia Sinica, Taiwan
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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