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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Intervention / Treatment
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

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

This is where you will find people and organizations involved with this study.

Sponsor

Academia Sinica, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 15, 2015

First Submitted That Met QC Criteria

November 5, 2015

First Posted (Estimate)

November 6, 2015

Study Record Updates

Last Update Posted (Estimate)

November 6, 2015

Last Update Submitted That Met QC Criteria

November 5, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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