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Study on the Effects of Wheat and Corn Germ Blend Oil on Antioxidation and Immune Regulation of Dyslipidemia Population

Effects of Phytosterol-rich Wheat Corn Germ Blended Oil on Immune Function, Oxidative Stress, Serum Metabolites and Intestinal Flora in Dyslipidaemic Population: A Randomised Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06060509
Enrollment
102
Registered
2023-09-29
Start date
2023-03-01
Completion date
2023-12-01
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemias, Fatty Acid Metabolism Disorder, Immune System Disorder, Metabolic Diseases, Oxidative Stress

Keywords

germ blend oil, Gut Microbiota, lipidomics, anti-oxidation, immune regulation, phytosterol

Brief summary

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: * How does phytosterol-rich wheat corn germ blended oil affect oxidative stress and immune function in dyslipidaemic people compared to peanut oil? * How does phytosterol-rich wheat corn germ blended oil affect serum metabolites, serum fatty acid profile, and intestinal flora in dyslipidaemic populations compared to peanut oil? What are the specific mechanisms involved? 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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTPhytosterol-rich Wheat and Corn Germ Blended Oil

Blending of corn germ oil and wheat germ oil supplied by Yihai Kerry to obtain germ blended oil with high phytosterol content.

DIETARY_SUPPLEMENTPeanut oil

Participants in the control group consumed peanut oil daily for cooking.

Sponsors

Chinese Nutrition Society
CollaboratorUNKNOWN
Zhongda Hospital
CollaboratorOTHER
Southeast University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Intervention model description

This is a randomised controlled intervention trial.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Male or female aged 18-65 with BMI less than 30; * At least one item meets the diagnostic criteria for dyslipidemia (2016 Chinese adult dyslipidemia prevention and treatment guide) * No serious complications related to liver, kidney, digestive tract, endocrine diseases and chronic diseases; * Within 3 months, he did not use the drugs and dietary supplements related to reducing blood fat and weight, and agreed not to use the above foods or drugs during the experiment; * Volunteer to participate in this study after listening to the project introduction and sign the informed consent form.

Exclusion criteria

* Pregnant, pregnant or lactating women; * Patients with liver and kidney dysfunction, diabetes, coronary heart disease, hyperthyroidism, malignant tumor, asthma and other chronic diseases other than dyslipidemia; * Endocrine disease patients, postoperative patients, patients receiving hormone therapy and psychotic patients; * Have special eating habits: vegetarian, ketogenic diet (high fat, low carbon water), etc; * Those who cannot follow the test requirements.

Design outcomes

Primary

MeasureTime frameDescription
glutathione12 weeksphysiological parameter
Immunoglobulin A12 weeksphysiological parameter
Immunoglobulin M12 weeksphysiological parameter
Complement C312 weeksphysiological parameter
Immunoglobulin E12 weeksphysiological parameter
reactive oxygen species12 weeksphysiological parameter
superoxide dismutase12 weeksphysiological parameter
malondialdehyde12 weeksphysiological parameter
Height in metres12 weeksHeight in metres, physiological parameter
Weight in kilogram12 weeksphysiological parameter
body mass index (BMI)12 weeksBMI= Weight (kg)/height\^2(m)
waist circumference12 weeksUnit in centimetres,physiological parameter
hip measurement12 weeksUnit in centimetres,physiological parameter
Systolic blood pressure12 weeksUnits in mmHg. physiological parameter.
diastolic blood pressure12 weeksUnits in mmHg. physiological parameter.
Serum triglyceride concentrations12 weeksphysiological parameter
Serum triglycerides concentrations12 weeksphysiological parameter
Serum LDL cholesterol concentrations12 weeksphysiological parameter
Serum HDL cholesterol concentrations12 weeksphysiological parameter
Percentage of CD3+ total T cells12 weeksphysiological parameter
Percentage of CD4+ T cells12 weeksphysiological parameter
Percentage of CD8+ T cells12 weeksphysiological parameter
Percentage of CD4+ CD8+ cells12 weeksphysiological parameter
Percentage of CD19+ B cells12 weeksphysiological parameter
Percentage of CD16/56+ NK cells12 weeksphysiological parameter
Immunoglobulin G12 weeksphysiological parameter

Secondary

MeasureTime frameDescription
leptin12 weeksphysiological parameter
Transforming growth factor-β12 weeksphysiological parameter
diamine oxidase12 weeksphysiological parameter
endotoxin12 weeksphysiological parameter
Number of participants who smoke12 weeksquestionnaire
Number of participants taking lipid-lowering drugs12 weeksquestionnaire
Lipoprotein a12 weeksphysiological parameter

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026