HealthyNCT04975048
SREBF1 Polymorphism and Egg Yolk on Cardiovascular Disease Risk in Healthy Young Adults: a Randomised, Two-period, Single Blinded, Crossover Trial
A study testing Egg yolks in people with Healthy and GEN1 Gene Mutation, run by Shandong University at 1 site in China.
Trial summary
Our previous analysis showed that sterol regulatory element binding protein gene (SREBF1) rs2236513/rs2297508/rs4925119 polymorphism modulated the relation between dietary cholesterol and serum low density lipoprotein cholesterol /serum total cholesterol. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, GEN1 Gene Mutation
- What is being tested?
- Egg yolks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2019to 22 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- SREBF1 C/G/G minor allele carriers and AA/CC/AA major homozygotes at rs2236513/rs2297508/rs4925119, age 18-25 years, body mass index (BMI) 18~23.9 kg/m2 , blood pressure within normal ranges (Systolic blood pressure < 140mmHg, diastolic blood pressure < 90mmHg), lipid profiles within normal ranges according to test kit instructions (fasting serum triglycerides < 1.7mmol/L, fasting serum total cholesterol < 5.2 mmol/L, fasting serum low density lipoprotein cholesterol (LDL-C) < 3.12 mmol/L, fasting serum high density lipoprotein cholesterol (HDL-C) >1.04 mmol/L ), liver and kidney functions within normal ranges according to test kit instructions (alanine aminotransferase (ALT) 9~50 U/L for male, 7~40 U/L for female; aspartate transaminase (AST) 15~40 U/L for male, 13~35 U/L for female; creatinine 62~115 μmol/L for male, 53~97 μmol/L for female; blood urea nitrogen (BUN), 1.43~7.14 mmol/L), both parents are Chinese Han nationality, willing to eat two or more eggs, and willing to maintain "Three Low Diet" except when they were given egg yolks during the study.
Who cannot join
- History of diabetes, cancer, stroke, heart disease or any other known diseases, allergic to eggs, or having habits such as drinking or smoking.
Trial locations and contacts
1 site in 1 country.
About this study
Our previous analysis showed that sterol regulatory element binding protein gene (SREBF1) rs2236513/rs2297508/rs4925119 polymorphism modulated the relation between dietary cholesterol and serum low density lipoprotein cholesterol /serum total cholesterol. This study aims to confirm and extend this finding by characterizing the effects of cholesterol from egg yolks on lipid profiles in healthy young adults with different SREBF1 genetic makeup. 32 SREBF1 C/G/G minor allele carriers at rs2236513/rs2297508/rs4925119 and 32 SREBF1 AA/CC/AA major homozygotes at rs2236513/rs2297508/rs4925119 were enrolled to test their response to egg yolks.
- Conditions
- Healthy, GEN1 Gene Mutation
- Being tested
- Egg yolks, Macronutrients equivalent control
- Keywords
- Gene-by-Diet Interaction, Egg Yolk, Sterol Regulatory Element Binding Protein 1 Gene, HDL-C, LDL-C/HDL-C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg yolksDietary supplement
Two egg yolks/day was designed for the study. However, uneven egg sizes during period 1 made the intervention unable to achieve the protocol's recommended cholesterol intake level, and the intervention was modified in period 2 to be 0.8 g egg yolk/day/kg body weight. This dosage was calculated by dividing the 35 g egg yolk with the lightest weight among the volunteers, which was 45 kg. This provides a more consistent cholesterol intake between persons as the egg yolk dosage is standardized for persons with different weights.
Macronutrients equivalent controlDietary supplement
The macronutrients equivalent control group was served 42 g egg white cooked with 10 g olive oil, designed to best imitate the energy and macronutrients of 35 g egg yolk (energy 119 kcal, protein 5 g, fat 10 g, carbohydrate 1 g) since the average weight of two large egg yolk was presumed to be 35 g. As an egg yolk dose of 0.8 g egg yolk per kg body weight per day was served during the intervention period 2, the macronutrients equivalent control was likewise adjusted as follow: subjects who weighed less than 55 kg were served 51 g egg white cooked with 12 g olive oil, which is equivalent to 40 g egg yolk; those who weighed from 55 kg to 65 kg were served 61 g egg white cooked with 14 g olive oil, which is equivalent to 48 g egg yolk; and those who weighed more than 65 kg were served 71 g egg white cooked with 17 g olive oil, which is equivalent to 56 g egg yolk.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A was consisted of 16 rs2236513/rs2297508/rs4925119 C/G/G carriers and 16 AA/CC/AA homozygotes. And it was first assigned egg yolk intervention during intervention period 1, and then macronutrient equivalent control during intervention period 2 Receives: Dietary Supplement: Egg yolks; Dietary Supplement: Macronutrients equivalent control |
| Group B | Other | Group B was also consisted of 16 rs2236513/rs2297508/rs4925119 C/G/G carriers and 16 AA/CC/AA homozygotes. It was first assigned macronutrient equivalent control during intervention period 1, and then egg yolk during intervention period 2 Receives: Dietary Supplement: Egg yolks; Dietary Supplement: Macronutrients equivalent control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum lipids
Serum lipids including serum total cholesterol, LDL-C, HDL-C and LDL-C/HDL-C, triglycerides
Measured: Week 0, week 4, week 8, week 16
Secondary outcomes (1)
Changes in Serum Cholesterol-Related Metabolites Measured by Targeted Analytical Assays and PBMC ABCA1 mRNA Expression Measured by RT-qPCR
Serum metabolites-Description Serum corticosteroid and bile acid concentrations were measured using targeted analytical assays. Changes were calculated as concentrations at the end minus those at the beginning of each intervention period.
PBMC ABCA1 mRNA-Description PBMC ABCA1 mRNA expression was measured by RT-qPCR and expressed using the ΔΔCt method. Changes were assessed from the beginning to the end of each intervention period.
Measured: At the beginning and end of each 4-week intervention period during the 16-week trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start14 May 2019
- Primary completion12 Jan 2020
- Study completion22 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Nutrition Society, Fudan University
- Responsible party
- Principal investigator, Shixiu Zhang, Shandong University
- Investigators
- Shixiu Zhang, Ph. D., Study chair, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975048
- Sponsor's protocol ID
- CNS-W2018A44
- Status last verified
- Sep 2026
- First submitted
- 30 Jun 2021
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SREBF1 Polymorphism and Egg Yolk on Cardiovascular Disease Risk in Healthy Young Adults: a Randomised, Two-period, Single Blinded, Crossover Trial
- ClinicalTrials.gov ID
- NCT04975048
- Acronym / sponsor ID
- CNS-W2018A44
- Conditions
- Healthy, GEN1 Gene Mutation
- Keywords
- Gene-by-Diet Interaction, Egg Yolk, Sterol Regulatory Element Binding Protein 1 Gene, HDL-C, LDL-C/HDL-C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Chinese Nutrition Society, Fudan University
- Study start
- 14 May 2019 (actual)
- Primary completion
- 12 Jan 2020 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our previous analysis showed that sterol regulatory element binding protein gene (SREBF1) rs2236513/rs2297508/rs4925119 polymorphism modulated the relation between dietary cholesterol and serum low density lipoprotein cholesterol /serum total cholesterol. This study aims to confirm and extend this finding by characterizing the effects of cholesterol from egg yolks on lipid profiles in healthy young adults with different SREBF1 genetic makeup. 32 SREBF1 C/G/G minor allele carriers at rs2236513/rs2297508/rs4925119 and 32 SREBF1 AA/CC/AA major homozygotes at rs2236513/rs2297508/rs4925119 were enrolled to test their response to egg yolks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Dietary Supplement: Egg yolks, Dietary Supplement: Macronutrients equivalent controlGroup A was consisted of 16 rs2236513/rs2297508/rs4925119 C/G/G carriers and 16 AA/CC/AA homozygotes. And it was first assigned egg yolk intervention during intervention period 1, and then macronutrient equivalent control during intervention period 2 |
| Group B | Other | Dietary Supplement: Egg yolks, Dietary Supplement: Macronutrients equivalent controlGroup B was also consisted of 16 rs2236513/rs2297508/rs4925119 C/G/G carriers and 16 AA/CC/AA homozygotes. It was first assigned macronutrient equivalent control during intervention period 1, and then egg yolk during intervention period 2 |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- SREBF1 C/G/G minor allele carriers and AA/CC/AA major homozygotes at rs2236513/rs2297508/rs4925119, age 18-25 years, body mass index (BMI) 18~23.9 kg/m2 , blood pressure within normal ranges (Systolic blood pressure < 140mmHg, diastolic blood pressure < 90mmHg), lipid profiles within normal ranges according to test kit instructions (fasting serum triglycerides < 1.7mmol/L, fasting serum total cholesterol < 5.2 mmol/L, fasting serum low density lipoprotein cholesterol (LDL-C) < 3.12 mmol/L, fasting serum high density lipoprotein cholesterol (HDL-C) >1.04 mmol/L ), liver and kidney functions within normal ranges according to test kit instructions (alanine aminotransferase (ALT) 9~50 U/L for male, 7~40 U/L for female; aspartate transaminase (AST) 15~40 U/L for male, 13~35 U/L for female; creatinine 62~115 μmol/L for male, 53~97 μmol/L for female; blood urea nitrogen (BUN), 1.43~7.14 mmol/L), both parents are Chinese Han nationality, willing to eat two or more eggs, and willing to maintain "Three Low Diet" except when they were given egg yolks during the study.
Key exclusion criteria (1 listed)
- History of diabetes, cancer, stroke, heart disease or any other known diseases, allergic to eggs, or having habits such as drinking or smoking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Egg yolksTwo egg yolks/day was designed for the study. However, uneven egg sizes during period 1 made the intervention unable to achieve the protocol's recommended cholesterol intake level, and the intervention was modified in period 2 to be 0.8 g egg yolk/day/kg body weight. This dosage was calculated by dividing the 35 g egg yolk with the lightest weight among the volunteers, which was 45 kg. This provides a more consistent cholesterol intake between persons as the egg yolk dosage is standardized for persons with different weights. | Dietary supplement | Group A, Group B |
| Macronutrients equivalent controlThe macronutrients equivalent control group was served 42 g egg white cooked with 10 g olive oil, designed to best imitate the energy and macronutrients of 35 g egg yolk (energy 119 kcal, protein 5 g, fat 10 g, carbohydrate 1 g) since the average weight of two large egg yolk was presumed to be 35 g. As an egg yolk dose of 0.8 g egg yolk per kg body weight per day was served during the intervention period 2, the macronutrients equivalent control was likewise adjusted as follow: subjects who weighed less than 55 kg were served 51 g egg white cooked with 12 g olive oil, which is equivalent to 40 g egg yolk; those who weighed from 55 kg to 65 kg were served 61 g egg white cooked with 14 g olive oil, which is equivalent to 48 g egg yolk; and those who weighed more than 65 kg were served 71 g egg white cooked with 17 g olive oil, which is equivalent to 56 g egg yolk. | Dietary supplement | Group A, Group B |
Primary outcome
Changes in serum lipids
Time frame: Week 0, week 4, week 8, week 16
Serum lipids including serum total cholesterol, LDL-C, HDL-C and LDL-C/HDL-C, triglycerides
1 secondary outcome
Changes in Serum Cholesterol-Related Metabolites Measured by Targeted Analytical Assays and PBMC ABCA1 mRNA Expression Measured by RT-qPCR
Time frame: At the beginning and end of each 4-week intervention period during the 16-week trial.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shixiu Zhang, Ph. D. study chair
Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Egg yolks in people with Healthy and GEN1 Gene Mutation, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in serum lipids (time frame: Week 0, week 4, week 8, week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.