NCT04975048

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy
• GEN1 Gene Mutation

Interventions

Type	Name	Description
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.
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2019-05-14
• Primary completion: 2020-01-12
• Completion: 2025-12-01
• First posted: 2021-07-23
• Last updated: 2025-05-15

Locations

1 site across 1 country: China