SREBF1 Polymorphism and Egg Yolk on Cardiovascular Disease Risk in Healthy Young Adults: a Randomised, Two-period, Single Blinded, Crossover Trial

Shandong University

Status: Suspended

Conditions: GEN1 Gene Mutation; Healthy

Treatments: Dietary Supplement: Egg yolks; Dietary Supplement: Macronutrients equivalent control

Study type: Interventional

Funder types: Other

Identifiers

NCT04975048

CNS-W2018A44

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• History of diabetes, cancer, stroke, heart disease or any other known diseases, allergic to eggs, or having habits such as drinking or smoking.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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64 participants in 2 patient groups

Group A

Experimental group

Description:

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

Treatment:

Dietary Supplement: Macronutrients equivalent control

Dietary Supplement: Egg yolks

Group B

Other group

Description:

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

Treatment:

Dietary Supplement: Macronutrients equivalent control

Dietary Supplement: Egg yolks