Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/07/2010
Date assigned
05/08/2010
Last edited
05/08/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sung Soo Kim

ORCID ID

Contact details

Department of Biochemistry and Molecular Biology
School of Medicine
Kyung Hee University
#1 Hoegi-Dong
Dongdaemoon-gu
Seoul
130-701
Korea
South
+82 (0)2 961 0524
sgskim@khu.ac.kr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Antioxidant enzymes induced by repeated intake of high-fat, high-carbohydrate meals are not sufficient to block oxidative stress in healthy lean subjects: A randomised controlled trial

Acronym

Study hypothesis

We hypothesised that repeated intake of high-fat, high-carbohydrate meals would increase oxidative stress and insulin resistance, and alter the expression of anti-oxidant enzymes and mitochondria electron transport chain complex subunits.

Ethics approval

Kyung Hee University Hospital Institutional Review Board approved on the 26th of April 2010 (ref: 1003-01-a3)

Study design

Single centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet.

Condition

Diet; oxidative stress; insulin resistance; protein dynamics

Intervention

Ten healthy, lean male Korean subjects were enrolled in this study. Subjects started a standardized diet for 7 days with control meals for breakfast, lunch and dinner, based on the Dietary Reference Intake for Koreans (KDRI) guidelines. Blood samples were collected at 2 hours after lunch on day 7 during intake period of KDRI control meals for the standardized diet. After the standardized diet, five subjects continually ingested KDRI control meals for breakfast, lunch and dinner, and the other five subjects ate HFHC meals only for lunch daily for 4 days.

We used western blot analysis to check the expression of related proteins and fluorescence-activated cell sorting analysis to confirm reactive oxygen species levels. To check blood glucose and insulin levels, oral glucose tolerance test was conducted for the subjects.

Results:
We showed that expression of anti-oxidant enzymes and mitochondria transport chain complex subunits was increased following high-fat, high-carbohydrate meals for 4 day in blood mononuclear cells, compared with that following control meals on day 7. However, there was an increase in intracytosolic lipid peroxidation and the induction of SOCS-3 which interferes with insulin signal transduction, indicating that oxidative stress was still progressing.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Oxidative stress
2. Anti-oxidant enzyme expressions
3. Mitochondria transport chain complex subunits expressions

Secondary outcome measures

Insulin resistance

Overall trial start date

06/05/2010

Overall trial end date

20/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy volunteers
2. Age 28 - 32 years
3. Male
4. Body Mass Index (BMI): 18.5 - 22.9

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

10 subjects

Participant exclusion criteria

1. Complete Blood Count (CBC): white blood cells - more than 6,000/ul
2. Fasting blood sugar test: blood sugar concentration - more than 100 mg/dl
3. Haemoglobin A1c: more than 6.0%

Recruitment start date

06/05/2010

Recruitment end date

20/05/2010

Locations

Countries of recruitment

Korea, South

Trial participating centre

Department of Biochemistry and Molecular Biology
Seoul
130-701
Korea, South

Sponsor information

Organisation

Kyung Hee University Medical Hospital (South Korea)

Sponsor details

c/o Sung Soo Kim
Department of Biochemistry and Molecular Biology
School of Medicine
#1 Hoegi-Dong
Dongdaemoon-gu
Seoul
130-701
Korea
South
+82 (0)2 961 0524
sgskim@khu.ac.kr

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Korean Government (South Korea) - Grant for Prof Sung Soo Kim (MEST NO: 20090091346)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes