Effect of high-fat, high-carbohydrate meals in human

ISRCTN	ISRCTN04309078
DOI	https://doi.org/10.1186/ISRCTN04309078
Secondary identifying numbers	N/A

Submission date: 21/07/2010
Registration date: 05/08/2010
Last edited: 05/08/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Sung Soo Kim
Scientific

Department of Biochemistry and Molecular Biology
School of Medicine
Kyung Hee University
#1 Hoegi-Dong
Dongdaemoon-gu
Seoul
130-701
Korea, South

Phone	+82 (0)2 961 0524
Email	sgskim@khu.ac.kr

Study information

Study design	Single centre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet.
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
Study objectives	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(s)	Kyung Hee University Hospital Institutional Review Board approved on the 26th of April 2010 (ref: 1003-01-a3)
Health condition(s) or problem(s) studied	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
Primary outcome measure	1. Oxidative stress 2. Anti-oxidant enzyme expressions 3. Mitochondria transport chain complex subunits expressions
Secondary outcome measures	Insulin resistance
Overall study start date	06/05/2010
Completion date	20/05/2010

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target number of participants	10 subjects
Key inclusion criteria	1. Healthy volunteers 2. Age 28 - 32 years 3. Male 4. Body Mass Index (BMI): 18.5 - 22.9
Key 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%
Date of first enrolment	06/05/2010
Date of final enrolment	20/05/2010

Locations

Countries of recruitment

Korea, South

Study participating centre

Department of Biochemistry and Molecular Biology

Seoul
130-701
Korea, South

Sponsor information

Kyung Hee University Medical Hospital (South Korea)
University/education

c/o Sung Soo Kim
Department of Biochemistry and Molecular Biology
School of Medicine
#1 Hoegi-Dong
Dongdaemoon-gu
Seoul
130-701
Korea, South

Phone	+82 (0)2 961 0524
Email	sgskim@khu.ac.kr
"ROR"	https://ror.org/01vbmek33

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan