Clinical trial NCT06060509: Study on the Effects of Wheat and Corn Germ Blend Oil on Antioxidation and Immune Regulation of Dyslipidemia Population
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Diseases
Immune System Disorder
Dyslipidemias
Fatty Acid Metabolism Disorder
Oxidative Stress
Keywords: germ blend oil
Gut Microbiota
lipidomics
anti-oxidation
immune regulation
phytosterol
Lead sponsor: Southeast University, China
Sponsor class: OTHER
Collaborators: name: Chinese Nutrition Society
name: Zhongda Hospital
First posted: 2023-09-29
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomised controlled intervention trial.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Height in metres
timeFrame: 12 weeks
measure: Weight in kilogram
timeFrame: 12 weeks
measure: body mass index (BMI)
timeFrame: 12 weeks
measure: waist circumference
timeFrame: 12 weeks
measure: hip measurement
timeFrame: 12 weeks
measure: Systolic blood pressure
timeFrame: 12 weeks
measure: diastolic blood pressure
timeFrame: 12 weeks
measure: Serum triglyceride concentrations
timeFrame: 12 weeks
measure: Serum triglycerides concentrations
timeFrame: 12 weeks
measure: Serum LDL cholesterol concentrations
timeFrame: 12 weeks
measure: Serum HDL cholesterol concentrations
timeFrame: 12 weeks
measure: Percentage of CD3+ total T cells
timeFrame: 12 weeks
measure: Percentage of CD4+ T cells
timeFrame: 12 weeks
measure: Percentage of CD8+ T cells
timeFrame: 12 weeks
measure: Percentage of CD4+ CD8+ cells
timeFrame: 12 weeks
measure: Percentage of CD19+ B cells
timeFrame: 12 weeks
measure: Percentage of CD16/56+ NK cells
timeFrame: 12 weeks
measure: Immunoglobulin G
timeFrame: 12 weeks
measure: Immunoglobulin A
timeFrame: 12 weeks
measure: Immunoglobulin M
timeFrame: 12 weeks
measure: Complement C3
timeFrame: 12 weeks
measure: Immunoglobulin E
timeFrame: 12 weeks
measure: reactive oxygen species
timeFrame: 12 weeks
measure: superoxide dismutase
timeFrame: 12 weeks
measure: malondialdehyde
timeFrame: 12 weeks
measure: glutathione
timeFrame: 12 weeks
Secondary outcomes:
measure: Lipoprotein a
timeFrame: 12 weeks
measure: leptin
timeFrame: 12 weeks
measure: Transforming growth factor-β
timeFrame: 12 weeks
measure: diamine oxidase
timeFrame: 12 weeks
measure: endotoxin
timeFrame: 12 weeks
measure: Number of participants who smoke
timeFrame: 12 weeks
measure: Number of participants taking lipid-lowering drugs
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Southeast university
state: Jiangsu
Study officials:
affiliation: Chinese Nutrition Society
name: Gui-ju Sun, phD
role: STUDY_DIRECTOR
References: