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

Sponsor

Southeast University, China (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06060509

Collaborator

Chinese Nutrition Society (Other), Zhongda Hospital (Other)

102

Enrollment

Location

Arms

Anticipated Duration (Months)

11.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Diseases Immune System Disorder Dyslipidemias Fatty Acid Metabolism Disorder Oxidative Stress	Dietary Supplement: Phytosterol-rich Wheat and Corn Germ Blended Oil Dietary Supplement: Peanut oil	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a randomised controlled intervention trial.This is a randomised controlled intervention trial.

Masking:

Double (Participant, 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.

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Mar 1, 2023

Actual Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Wheat corn germ blended oil group 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.	Dietary Supplement: Phytosterol-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.
Other: Peanut oil group 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.	Dietary Supplement: Peanut oil Participants in the control group consumed peanut oil daily for cooking.

Arm

Intervention/Treatment

Experimental: Wheat corn germ blended oil group

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.

Dietary Supplement: Phytosterol-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.

Other: Peanut oil group

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.

Dietary Supplement: Peanut oil

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

Outcome Measures

Primary Outcome Measures

Height in metres [12 weeks]
Height in metres, physiological parameter
Weight in kilogram [12 weeks]
physiological parameter
body mass index (BMI) [12 weeks]
BMI= Weight (kg)/height^2(m)
waist circumference [12 weeks]
Unit in centimetres,physiological parameter
hip measurement [12 weeks]
Unit in centimetres,physiological parameter
Systolic blood pressure [12 weeks]
Units in mmHg. physiological parameter.
diastolic blood pressure [12 weeks]
Units in mmHg. physiological parameter.
Serum triglyceride concentrations [12 weeks]
physiological parameter
Serum triglycerides concentrations [12 weeks]
physiological parameter
Serum LDL cholesterol concentrations [12 weeks]
physiological parameter
Serum HDL cholesterol concentrations [12 weeks]
physiological parameter
Percentage of CD3+ total T cells [12 weeks]
physiological parameter
Percentage of CD4+ T cells [12 weeks]
physiological parameter
Percentage of CD8+ T cells [12 weeks]
physiological parameter
Percentage of CD4+ CD8+ cells [12 weeks]
physiological parameter
Percentage of CD19+ B cells [12 weeks]
physiological parameter
Percentage of CD16/56+ NK cells [12 weeks]
physiological parameter
Immunoglobulin G [12 weeks]
physiological parameter
Immunoglobulin A [12 weeks]
physiological parameter
Immunoglobulin M [12 weeks]
physiological parameter
Complement C3 [12 weeks]
physiological parameter
Immunoglobulin E [12 weeks]
physiological parameter
reactive oxygen species [12 weeks]
physiological parameter
superoxide dismutase [12 weeks]
physiological parameter
malondialdehyde [12 weeks]
physiological parameter
glutathione [12 weeks]
physiological parameter

Secondary Outcome Measures

Lipoprotein a [12 weeks]
physiological parameter
leptin [12 weeks]
physiological parameter
Transforming growth factor-β [12 weeks]
physiological parameter
diamine oxidase [12 weeks]
physiological parameter
endotoxin [12 weeks]
physiological parameter
Number of participants who smoke [12 weeks]
questionnaire
Number of participants taking lipid-lowering drugs [12 weeks]
questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.