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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04975048
• Other study ID #: CNS-W2018A44
• Status: Suspended
• Phase: N/A
• Start date: May 14, 2019
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 64
• Est. completion date: June 1, 2025
• Est. primary completion date: January 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• GEN1 Gene Mutation
• Healthy

Intervention

Dietary Supplement:
• Egg yolks
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 control
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.

Locations

Country	Name	City	State
China	Shandong University	Jinan	Shandong

Sponsors (3)

Lead Sponsor	Collaborator
Shandong University	Chinese Nutrition Society, Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in serum lipids	Serum lipids including serum total cholesterol, LDL-C, HDL-C and LDL-C/HDL-C, triglycerides	Week 0, week 4, week 8, week 16