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CompletedNCT03406910ESUpdated Jan 23, 2018

Egg Intake and Risk of Type 2 Diabetes

An observational study in Type 2 Diabetes and Heart Diseases, sponsored by Loma Linda University. Completed at 1 site in United States. Open to participants aged 31 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Loma Linda University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
55,851
Ages
31 Years and older
Sex
All
01

Study summary

This is a longitudinal study that will collect demographic, anthropometric and dietary data to determine the relationships between meat and egg intake and the incidence of Type 2 Diabetes.

Read the detailed description

Subjects of the Adventist Health Study who are non-diabetic will provide demographic, anthropometric and dietary data at baseline. Meat and egg intake will be assessed with a validated quantitative food frequency intake questionnaire. The relationship between meat and egg intake and the incidence of Type 2 Diabetes will be determined using multivariate-adjusted logistic regression.

02

Conditions studied

  • Type 2 Diabetes
  • Heart Diseases

Keywords

  • egg
  • meat
  • western diet
  • type 2 diabetes
  • Adventist Health Study
  • Vegetarian cohort
  • Adventist
03

Who can participate

Ages eligible
31 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The AHS-2 is a prospective cohort of >96,000 Seventh-day Adventist adults recruited from the USA and Canada between February 2002 and May 2007. Designed primarily to examine associations between diet and health outcomes, the study is composed of approximately 65% females and 27% blacks. Recruitment and data collection methods for the parent cohort have been described previously. The cohort is composed of participants with different dietary patterns and a wide variation in egg and meat intake ranging from non-consumption to daily consumption. Approval for the AHS-2 study was obtained from the Loma Linda University Human Subjects Committee Institutional Review Board and written informed consent was acquired from all AHS-2 participants upon enrollment.

Inclusion criteria

  • AHS 2 Participants who filled out Hospital History Questionnaire version 3 or 5 Age > 30 years

Exclusion criteria

Exclusion Criteria:

  • Subjects with missing values in dietary variables were excluded from the analytic sample,
  • missing gender
  • age \< 30 years
  • improbable questionnaire response patterns
  • extremes of BMI (less than 16 or greater than 60)
  • estimated energy intake (less than 500 or greater than 4,500 kcal/d)
  • existing cases of type 1 or type 2 diabetes at baseline
  • inconsistent reports of T2D between HHQ version 3 and 5
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
55,851 participants (actual)
Patient registry
No

Groups and cohorts

  • Seventh day Adventist adults

    Seventh day Adventist adults recruited from the USA and Canada. Approximately 65% female and 35% male. Composed of participants with different dietary patterns and a wide variation in egg and meat intake ranging from non-consumptive to daily consumption.

05

What researchers measure

Primary outcomes

  1. Risk for Type 2 Diabetes (T2D) in subjects who consume different frequencies/amounts of eggs and meat.

    Validated quantitative food frequency questionnaire that compares risk of T2D in subjects who consume different frequencies /amounts of egg and meat and physician diagnosis of diabetes

    Time frame: Change between baseline and 5 Years of follow up

06

Study locations

1 site
  • Loma Linda University
    Loma Linda, California 92350, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03406910
Lead sponsor
Loma Linda University
Collaborators
American Egg Board
Responsible party
Joan Sabate,DrPH, MD (Professor of Nutrition and Epidemiology, Loma Linda University) — Principal investigator
First posted
Jan 23, 2018
Start date
Feb 13, 2015
Primary completion
Jun 30, 2017
Completion
Jun 30, 2017
Last update
Jan 23, 2018

Study contacts

Joan Sabate, DrPH
principal investigator · Loma Linda University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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