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

Oxidative Stress Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06060509
• Other study ID #: 2022ZDSYLL031-P02
• Secondary ID: CNS-NNSRG2021-39
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: November 2023
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: November 30, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias
• Immune System Diseases
• Immune System Disorder
• Metabolic Diseases
• Oxidative Stress

Intervention

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

Locations

Country	Name	City	State
China	Southeast university	Nanjing	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Southeast University, China	Chinese Nutrition Society, Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Height in metres	Height in metres, physiological parameter	12 weeks
Primary	Weight in kilogram	physiological parameter	12 weeks
Primary	body mass index (BMI)	BMI= Weight (kg)/height^2(m)	12 weeks
Primary	waist circumference	Unit in centimetres,physiological parameter	12 weeks
Primary	hip measurement	Unit in centimetres,physiological parameter	12 weeks
Primary	Systolic blood pressure	Units in mmHg. physiological parameter.	12 weeks
Primary	diastolic blood pressure	Units in mmHg. physiological parameter.	12 weeks
Primary	Serum triglyceride concentrations	physiological parameter	12 weeks
Primary	Serum triglycerides concentrations	physiological parameter	12 weeks
Primary	Serum LDL cholesterol concentrations	physiological parameter	12 weeks
Primary	Serum HDL cholesterol concentrations	physiological parameter	12 weeks
Primary	Percentage of CD3+ total T cells	physiological parameter	12 weeks
Primary	Percentage of CD4+ T cells	physiological parameter	12 weeks
Primary	Percentage of CD8+ T cells	physiological parameter	12 weeks
Primary	Percentage of CD4+ CD8+ cells	physiological parameter	12 weeks
Primary	Percentage of CD19+ B cells	physiological parameter	12 weeks
Primary	Percentage of CD16/56+ NK cells	physiological parameter	12 weeks
Primary	Immunoglobulin G	physiological parameter	12 weeks
Primary	Immunoglobulin A	physiological parameter	12 weeks
Primary	Immunoglobulin M	physiological parameter	12 weeks
Primary	Complement C3	physiological parameter	12 weeks
Primary	Immunoglobulin E	physiological parameter	12 weeks
Primary	reactive oxygen species	physiological parameter	12 weeks
Primary	superoxide dismutase	physiological parameter	12 weeks
Primary	malondialdehyde	physiological parameter	12 weeks
Primary	glutathione	physiological parameter	12 weeks
Secondary	Lipoprotein a	physiological parameter	12 weeks
Secondary	leptin	physiological parameter	12 weeks
Secondary	Transforming growth factor-ß	physiological parameter	12 weeks
Secondary	diamine oxidase	physiological parameter	12 weeks
Secondary	endotoxin	physiological parameter	12 weeks
Secondary	Number of participants who smoke	questionnaire	12 weeks
Secondary	Number of participants taking lipid-lowering drugs	questionnaire	12 weeks