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

NCT04975048 | Suspended

• 1 other identifier: CNS-W2018A44
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gene-by-Diet Interaction; Egg Yolk; Sterol Regulatory Element Binding Protein 1 Gene; HDL-C; LDL-C/HDL-C

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

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

Interventions

Egg yolks DIETARY_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.

Group A; Group B

Macronutrients equivalent control DIETARY_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.

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shandong University: lead
• Chinese Nutrition Society: collaborator
• Fudan University: collaborator

Study Sites (1)

Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Interventions

Egg Yolk

Intervention Hierarchy (Ancestors)

Eggs; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Shixiu Zhang, Ph. D.

  Shandong University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Masking was applied for those who collected blood samples, physical examination data, and assessed laboratory outcomes. People who were masked did not participate in the routine management meetings of the trial.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 23, 2021
• Study Start: May 14, 2019
• Primary Completion: January 12, 2020
• Study Completion: December 1, 2025
• Last Updated: May 15, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: All IPD that underlie results in a publication will be shared as claimed by the journal that the publication is published.
• Access Criteria: Can access data by contacting Shixiu Zhang.

Locations

CN (1)