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| ID | Type | Description | Link |
|---|---|---|---|
| CNS-NNSRG2021-39 | Other Grant/Funding Number | Chinese Society of Nutrition |
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| Name | Class |
|---|---|
| Chinese Nutrition Society | UNKNOWN |
| Zhongda Hospital | OTHER |
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The goal of this clinical trial is to explore the role of wheat and corn germ blended oils in regulating oxidative stress and immunomodulation in dyslipidaemic populations, to explore their effects on intestinal flora, antioxidant and immunomodulation. The main questions it aims to answer are:
Participants will be randomly assigned to the intervention and control groups, the packaging of germ oil and peanut oil will have a uniform appearance, and participants will be instructed to replace their household cooking oils with the distributed cooking oil for three months, in addition to replacing all the canteens in the staff units with the trial oil for more than three months. Participants did not know who was the control oil, germ oil or peanut oil, and both were randomly distributed to different groups of participants by the third-party supervisors.
Researchers will compare peanut oil to see if phytosterol-rich germ oil can improve oxidative stress and immune function in dyslipidaemic populations, in addition to exploring possible underlying mechanisms of improvement using multi-omics techniques.
The design of this intervention trial was a randomised controlled trial, in which the included dyslipidaemic population was randomly divided into a wheat corn germ blended oil intervention group and a peanut oil control group, with the male/female ratio, age, and level of basic clinical characteristics balanced between the two groups. The entire test phase consisted of a 14-day washout period and a 3-month intervention period. Participants in the intervention and control groups first entered a 14-day peanut oil washout period, which was followed by a three-month intervention phase. During the intervention phase, two different cooking oils (25-30 g of cooking oil per day according to the recommended intake of the Chinese Nutrition Society) were allocated to the two groups, with peanut oil being consumed by participants in the control group, and germ oil being used to replace the daily cooking oil for participants in the intervention group. After the participants were randomised into groups, they were provided with lunch and dinner according to the Chinese Dietary Guidelines for Residents of China and the local dietary habits of Nanjing, China, and breakfast was provided by the subjects themselves (dietary guidance was given to the subjects during the course of the study, and breakfast recipes were provided uniformly in order to achieve consistency between the two groups), and the intervention period was 3 months. Throughout the project period, all subjects followed their normal dietary habits and maintained a normal level of physical activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wheat corn germ blended oil group | Experimental | Participants in the intervention group replaced the daily cooking oil with wheat and corn germ oil, and were given 25-30 g of cooking oil per day according to the recommended intake of the Chinese Nutrition Society. Lunch and dinner were cooked using a uniform recipe for both intervention and control groups, and breakfast was self-cooked under the uniform dietary guidelines. |
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| Peanut oil group | Other | Participants in the Peanut oil group replaced the daily cooking oil with Peanut oil, and were given 25-30 g of cooking oil per day according to the recommended intake of the Chinese Nutrition Society. Lunch and dinner were cooked using a uniform recipe for both intervention and control groups, and breakfast was self-cooked under the uniform dietary guidelines. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phytosterol-rich Wheat and Corn Germ Blended Oil | Dietary Supplement | Blending of corn germ oil and wheat germ oil supplied by Yihai Kerry to obtain germ blended oil with high phytosterol content. |
| Measure | Description | Time Frame |
|---|---|---|
| Height in metres | Height in metres, physiological parameter | 12 weeks |
| Weight in kilogram | physiological parameter | 12 weeks |
| body mass index (BMI) | BMI= Weight (kg)/height^2(m) | 12 weeks |
| waist circumference | Unit in centimetres,physiological parameter | 12 weeks |
| hip measurement | Unit in centimetres,physiological parameter | 12 weeks |
| Systolic blood pressure | Units in mmHg. physiological parameter. | 12 weeks |
| diastolic blood pressure | Units in mmHg. physiological parameter. | 12 weeks |
| Serum triglyceride concentrations | physiological parameter | 12 weeks |
| Serum triglycerides concentrations | physiological parameter |
| Measure | Description | Time Frame |
|---|---|---|
| Lipoprotein a | physiological parameter | 12 weeks |
| leptin | physiological parameter | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gui-ju Sun, phD | Chinese Nutrition Society | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southeast university | Nanjing | Jiangsu | 210000 | China |
There's no plan for that yet.
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This is a randomised controlled intervention trial.
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The packaging of intervention oil and control oil was consistent, and the subjects could not distinguish what was blend oil and what was control oil. Blinding was also used for outcome assessors, who did not distinguish between the intervention and control groups.
| Peanut oil | Dietary Supplement | Participants in the control group consumed peanut oil daily for cooking. |
|
| 12 weeks |
| Serum LDL cholesterol concentrations | physiological parameter | 12 weeks |
| Serum HDL cholesterol concentrations | physiological parameter | 12 weeks |
| Percentage of CD3+ total T cells | physiological parameter | 12 weeks |
| Percentage of CD4+ T cells | physiological parameter | 12 weeks |
| Percentage of CD8+ T cells | physiological parameter | 12 weeks |
| Percentage of CD4+ CD8+ cells | physiological parameter | 12 weeks |
| Percentage of CD19+ B cells | physiological parameter | 12 weeks |
| Percentage of CD16/56+ NK cells | physiological parameter | 12 weeks |
| Immunoglobulin G | physiological parameter | 12 weeks |
| Immunoglobulin A | physiological parameter | 12 weeks |
| Immunoglobulin M | physiological parameter | 12 weeks |
| Complement C3 | physiological parameter | 12 weeks |
| Immunoglobulin E | physiological parameter | 12 weeks |
| reactive oxygen species | physiological parameter | 12 weeks |
| superoxide dismutase | physiological parameter | 12 weeks |
| malondialdehyde | physiological parameter | 12 weeks |
| glutathione | physiological parameter | 12 weeks |
| Transforming growth factor-β | physiological parameter | 12 weeks |
| diamine oxidase | physiological parameter | 12 weeks |
| endotoxin | physiological parameter | 12 weeks |
| Number of participants who smoke | questionnaire | 12 weeks |
| Number of participants taking lipid-lowering drugs | questionnaire | 12 weeks |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D007154 | Immune System Diseases |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D052439 | Lipid Metabolism Disorders |
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| ID | Term |
|---|---|
| D000074241 | Peanut Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
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