Type 2 DiabetesESNCT03406910
Egg Intake and Risk of Type 2 Diabetes
An observational study of Type 2 Diabetes and Heart Diseases, run by Loma Linda University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 31 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Heart Diseases
- How many people
- 55,851 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2015to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- AHS 2 Participants who filled out Hospital History Questionnaire version 3 or 5 Age > 30 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Egg Intake and Risk of Type 2 Diabetes in a Low Meat Intake Population
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.
- Conditions
- Type 2 Diabetes, Heart Diseases
- Keywords
- egg, meat, western diet, type 2 diabetes, Adventist Health Study, Vegetarian cohort, Adventist
- Medical subject headings
- Diabetes Mellitus, Type 2, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change between baseline and 5 Years of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start13 Feb 2015
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55,851 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- American Egg Board
- Responsible party
- Principal investigator, Joan Sabate,DrPH, MD, Loma Linda University
- Investigators
- Joan Sabate, DrPH, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406910
- Sponsor's protocol ID
- 2140392
- Acronym
- ES
- Status last verified
- Jan 2018
- First submitted
- 16 Jan 2018
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Egg Intake and Risk of Type 2 Diabetes in a Low Meat Intake Population
- ClinicalTrials.gov ID
- NCT03406910
- Acronym / sponsor ID
- ES / 2140392
- Conditions
- Type 2 Diabetes, Heart Diseases
- Keywords
- egg, meat, western diet, type 2 diabetes, Adventist Health Study, Vegetarian cohort, Adventist
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55,851 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- American Egg Board
- Study start
- 13 Feb 2015 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 31 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- AHS 2 Participants who filled out Hospital History Questionnaire version 3 or 5 Age > 30 years
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk for Type 2 Diabetes (T2D) in subjects who consume different frequencies/amounts of eggs and meat.
Time frame: Change between baseline and 5 Years of follow up
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Sabate, DrPH principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Heart Diseases, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk for Type 2 Diabetes (T2D) in subjects who consume different frequencies/amounts of eggs and meat. (time frame: Change between baseline and 5 Years of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018; AzTrials last refreshed its copy on 6 Nov 2026.