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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02599103
Other study ID # AS-IRB02-102083
Secondary ID
Status Completed
Phase N/A
First received September 15, 2015
Last updated November 5, 2015
Start date September 2013
Est. completion date September 2015

Study information

Verified date October 2015
Source Academia Sinica, Taiwan
Contact n/a
Is FDA regulated No
Health authority Academia Sinica:Taiwan
Study type Interventional

Clinical 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). 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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 50 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Fat-free milkshake
participants drinks a fat-free milk shakes
Olive oil
participants drinks the milk shakes prepared from 60g of olive oil
Soybean oil
participants drinks the milk shakes prepared from 60g of soybean oil
Fried soybean oil
participants drinks the milk shakes prepared from 60g of fried soybean oil
Palm oil
participants drinks the milk shakes prepared from 60g of palm oil
Fried palm oil
participants drinks the milk shakes prepared from 60g of fried palm oil
Camellia oil
participants drinks the milk shakes prepared from 60g of camellia oil
Fried camellia oil
participants drinks the milk shakes prepared from 60g of fried camellia oil
Tallow
participants drinks the milk shakes prepared from 60g of tallow
Fried tallow
participants drinks the milk shakes prepared from 60g of fried tallow

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Academia Sinica, Taiwan

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline to 2 hours and 4 hours after oil consumption No
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