NCT03406910

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55,851

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

2.4 years

First QC Date

January 16, 2018

Last Update Submit

January 16, 2018

Conditions

Keywords

eggmeatwestern diettype 2 diabetesAdventist Health StudyVegetarian cohortAdventist

Outcome Measures

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

    Change between baseline and 5 Years of follow up

Study Arms (1)

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.

Eligibility Criteria

Age31 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Heart Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCardiovascular Diseases

Study Officials

  • Joan Sabate, DrPH

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition and Epidemiology

Study Record Dates

First Submitted

January 16, 2018

First Posted

January 23, 2018

Study Start

February 13, 2015

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

January 23, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations