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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Diseases; Dyslipidemias; Oxidative Stress; Immune System Disorder; Fatty Acid Metabolism Disorder
• Intervention / Treatment: Dietary supplement: Phytosterol-rich Wheat and Corn Germ Blended Oil; Dietary supplement: Peanut oil

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 Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Southeast university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
Serum triglyceride concentrations	physiological parameter	12 weeks
Serum triglycerides concentrations	physiological parameter	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
Systolic blood pressure	Units in mmHg. physiological parameter.	12 weeks
diastolic blood pressure	Units in mmHg. physiological parameter.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipoprotein a	physiological parameter	12 weeks
leptin	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

Collaborators and Investigators

• Sponsor: Southeast University, China
• Collaborators: Zhongda Hospital; Chinese Nutrition Society
• Investigators: Study Director: Gui-ju Sun, phD, Chinese Nutrition Society

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: September 23, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Gut Microbiota; immune regulation; lipidomics; germ blend oil; anti-oxidation; phytosterol
• Additional Relevant MeSH Terms: Lipid Metabolism Disorders; Dyslipidemias; Metabolic Diseases; Immune System Diseases
• Other Study ID Numbers: 2022ZDSYLL031-P02; CNS-NNSRG2021-39 (Other Grant/Funding Number: Chinese Society of Nutrition)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There's no plan for that yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No