NCT02599103

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
Last Updated

November 6, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

September 15, 2015

Last Update Submit

November 5, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (10)

fat-free milkshake

PLACEBO COMPARATOR
Other: Fat-free milkshake

Olive oil

ACTIVE COMPARATOR
Other: Olive oil

soybean oil

EXPERIMENTAL
Other: Soybean oil

fried soybean oil

EXPERIMENTAL
Other: Fried soybean oil

palm oil

EXPERIMENTAL
Other: Palm oil

fried palm oil

EXPERIMENTAL
Other: Fried palm oil

camellia oil

EXPERIMENTAL
Other: Camellia oil

fried camellia oil

EXPERIMENTAL
Other: Fried camellia oil

tallow

EXPERIMENTAL
Other: Tallow

fried tallow

EXPERIMENTAL
Other: Fried tallow

Interventions

participants drinks a fat-free milk shakes

fat-free milkshake

participants drinks the milk shakes prepared from 60g of olive oil

Olive oil

participants drinks the milk shakes prepared from 60g of soybean oil

soybean oil

participants drinks the milk shakes prepared from 60g of fried soybean oil

fried soybean oil

participants drinks the milk shakes prepared from 60g of palm oil

palm oil

participants drinks the milk shakes prepared from 60g of fried palm oil

fried palm oil

participants drinks the milk shakes prepared from 60g of camellia oil

camellia oil

participants drinks the milk shakes prepared from 60g of fried camellia oil

fried camellia oil
TallowOTHER

participants drinks the milk shakes prepared from 60g of tallow

tallow

participants drinks the milk shakes prepared from 60g of fried tallow

fried tallow

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Olive OilSoybean OilPalm Oiltallow

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Wen-Harn Pan, Ph.D.

    Institute of Biomedical Sciences, Academia Sinica

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Institute of Biomedical Sciences

Study Record Dates

First Submitted

September 15, 2015

First Posted

November 6, 2015

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 6, 2015

Record last verified: 2015-10