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

Primary Purpose

Metabolic Diseases, Immune System Disorder, Dyslipidemias

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Phytosterol-rich Wheat and Corn Germ Blended Oil
Peanut oil
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metabolic Diseases focused on measuring germ blend oil, Gut Microbiota, lipidomics, anti-oxidation, immune regulation, phytosterol

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Zhongda Hospital, Affiliated to Southeast University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Wheat corn germ blended oil group

Peanut oil group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 19, 2023
Last Updated
October 2, 2023
Sponsor
Southeast University, China
Collaborators
Chinese Nutrition Society, Zhongda Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06060509
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China
Collaborators
Chinese Nutrition Society, Zhongda Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Diseases, Immune System Disorder, Dyslipidemias, Fatty Acid Metabolism Disorder, Oxidative Stress
Keywords
germ blend oil, Gut Microbiota, lipidomics, anti-oxidation, immune regulation, phytosterol

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomised controlled intervention trial.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wheat corn germ blended oil group
Arm Type
Experimental
Arm Description
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.
Arm Title
Peanut oil group
Arm Type
Other
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Phytosterol-rich Wheat and Corn Germ Blended Oil
Intervention Description
Blending of corn germ oil and wheat germ oil supplied by Yihai Kerry to obtain germ blended oil with high phytosterol content.
Intervention Type
Dietary Supplement
Intervention Name(s)
Peanut oil
Intervention Description
Participants in the control group consumed peanut oil daily for cooking.
Primary Outcome Measure Information:
Title
Height in metres
Description
Height in metres, physiological parameter
Time Frame
12 weeks
Title
Weight in kilogram
Description
physiological parameter
Time Frame
12 weeks
Title
body mass index (BMI)
Description
BMI= Weight (kg)/height^2(m)
Time Frame
12 weeks
Title
waist circumference
Description
Unit in centimetres,physiological parameter
Time Frame
12 weeks
Title
hip measurement
Description
Unit in centimetres,physiological parameter
Time Frame
12 weeks
Title
Systolic blood pressure
Description
Units in mmHg. physiological parameter.
Time Frame
12 weeks
Title
diastolic blood pressure
Description
Units in mmHg. physiological parameter.
Time Frame
12 weeks
Title
Serum triglyceride concentrations
Description
physiological parameter
Time Frame
12 weeks
Title
Serum triglycerides concentrations
Description
physiological parameter
Time Frame
12 weeks
Title
Serum LDL cholesterol concentrations
Description
physiological parameter
Time Frame
12 weeks
Title
Serum HDL cholesterol concentrations
Description
physiological parameter
Time Frame
12 weeks
Title
Percentage of CD3+ total T cells
Description
physiological parameter
Time Frame
12 weeks
Title
Percentage of CD4+ T cells
Description
physiological parameter
Time Frame
12 weeks
Title
Percentage of CD8+ T cells
Description
physiological parameter
Time Frame
12 weeks
Title
Percentage of CD4+ CD8+ cells
Description
physiological parameter
Time Frame
12 weeks
Title
Percentage of CD19+ B cells
Description
physiological parameter
Time Frame
12 weeks
Title
Percentage of CD16/56+ NK cells
Description
physiological parameter
Time Frame
12 weeks
Title
Immunoglobulin G
Description
physiological parameter
Time Frame
12 weeks
Title
Immunoglobulin A
Description
physiological parameter
Time Frame
12 weeks
Title
Immunoglobulin M
Description
physiological parameter
Time Frame
12 weeks
Title
Complement C3
Description
physiological parameter
Time Frame
12 weeks
Title
Immunoglobulin E
Description
physiological parameter
Time Frame
12 weeks
Title
reactive oxygen species
Description
physiological parameter
Time Frame
12 weeks
Title
superoxide dismutase
Description
physiological parameter
Time Frame
12 weeks
Title
malondialdehyde
Description
physiological parameter
Time Frame
12 weeks
Title
glutathione
Description
physiological parameter
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Lipoprotein a
Description
physiological parameter
Time Frame
12 weeks
Title
leptin
Description
physiological parameter
Time Frame
12 weeks
Title
Transforming growth factor-β
Description
physiological parameter
Time Frame
12 weeks
Title
diamine oxidase
Description
physiological parameter
Time Frame
12 weeks
Title
endotoxin
Description
physiological parameter
Time Frame
12 weeks
Title
Number of participants who smoke
Description
questionnaire
Time Frame
12 weeks
Title
Number of participants taking lipid-lowering drugs
Description
questionnaire
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gui-ju Sun, phD
Organizational Affiliation
Chinese Nutrition Society
Official's Role
Study Director
Facility Information:
Facility Name
Zhongda Hospital, Affiliated to Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There's no plan for that yet.

Learn more about this trial

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

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