NCT06060509

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

September 19, 2023

Last Update Submit

October 9, 2024

Conditions

Metabolic DiseasesImmune System DisorderDyslipidemiasFatty Acid Metabolism DisorderOxidative Stress

Keywords

germ blend oilGut Microbiotalipidomicsanti-oxidationimmune regulationphytosterol

Outcome Measures

Primary Outcomes (26)

  • 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

  • Systolic blood pressure

    Units in mmHg. physiological parameter.

    12 weeks

  • diastolic blood pressure

    Units in mmHg. 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

Secondary Outcomes (7)

  • Lipoprotein a

    12 weeks

  • leptin

    12 weeks

  • Transforming growth factor-β

    12 weeks

  • diamine oxidase

    12 weeks

  • endotoxin

    12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Wheat corn germ blended oil group

EXPERIMENTAL

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

Peanut oil group

OTHER

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

Interventions

Phytosterol-rich Wheat and Corn Germ Blended OilDIETARY_SUPPLEMENT

Blending of corn germ oil and wheat germ oil supplied by Yihai Kerry to obtain germ blended oil with high phytosterol content.

Wheat corn germ blended oil group
Peanut oilDIETARY_SUPPLEMENT

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

Peanut oil group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southeast university

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Metabolic DiseasesImmune System DiseasesDyslipidemias

Interventions

Peanut Oil

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOils

Study Officials

  • Gui-ju Sun, phD

    Chinese Nutrition Society

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is a randomised controlled intervention trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 19, 2023

First Posted

September 29, 2023

Study Start

March 1, 2023

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

There's no plan for that yet.

Locations

CN(1)