Effect of high-fat, high-carbohydrate meals in human
| ISRCTN | ISRCTN04309078 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04309078 |
| Protocol serial number | N/A |
| Sponsor | Kyung Hee University Medical Hospital (South Korea) |
| Funder | Korean Government (South Korea) - Grant for Prof Sung Soo Kim (MEST NO: 20090091346) |
- 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
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 |
|---|---|
| sgskim@khu.ac.kr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
1. Oxidative stress |
| Key secondary outcome measure(s) |
Insulin resistance |
| Completion date | 20/05/2010 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 10 |
| 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
130-701
Korea, South
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
