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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03615599
Other study ID # 48134
Secondary ID U01CA152939R01CA
Status Active, not recruiting
Phase
First received
Last updated
Start date February 1, 2002
Est. completion date December 2024

Study information

Verified date November 2023
Source Loma Linda University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Adventist Health Study-2 is a long-term study, exploring the links between lifestyle, diet, and disease outcomes among Seventh-day Adventists. More than 96,000 church members from the U.S. and Canada are participating in the current study, AHS-2, conducted by researchers at the Loma Linda University School of Public Health.


Description:

The Adventist Health Study-2 (AHS-2) is a large national cohort of 96,000 Seventh-day Adventists in the U.S. and Canada. The study is searching for associations between diet and risk of common and medium frequency cancers (breast, prostate, colorectal, lung, uterus, pancreas, melanoma of skin). This cohort is unusual in that about half are vegetarian, many eat soy at Asian levels, and many have very low or absent dairy intake while others eat normal amounts of dairy. Thus observations on these people, many of whom have contrasting dietary habits, may provide insights about diet and cancer, so supporting dietary changes that could be readily adopted by many.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 96000
Est. completion date December 2024
Est. primary completion date December 31, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years and older
Eligibility Inclusion Criteria: - Member of a Seventh-day Adventist church >30 years of age Ability to read English Live in the US or Canada Exclusion Criteria: - Less than 30 years of age - Church members who did not complete the baseline questionnaire. - Incarcerated or institutionalized people - Non-English speakers

Study Design


Locations

Country Name City State
United States Loma Linda University Loma Linda California

Sponsors (4)

Lead Sponsor Collaborator
Loma Linda University Ardmore Institute of Health, National Cancer Institute (NCI), World Cancer Research Fund International

Country where clinical trial is conducted

United States, 

References & Publications (1)

Butler TL, Fraser GE, Beeson WL, Knutsen SF, Herring RP, Chan J, Sabate J, Montgomery S, Haddad E, Preston-Martin S, Bennett H, Jaceldo-Siegl K. Cohort profile: The Adventist Health Study-2 (AHS-2). Int J Epidemiol. 2008 Apr;37(2):260-5. doi: 10.1093/ije/dym165. Epub 2007 Aug 27. No abstract available. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Incident cases of colorectal cancer among subjects with documented dietary habits. Incident cases of colorectal cancer as found by linkage with state cancer registries will allow calculation of hazard ratios comparing extreme quintiles of dietary intakes. The focus is on meats, soy, and dairy intakes. Linkage with state cancer registries occurs periodically for 9 years, with first linkage at year 04 of study enrolment.
Primary Incident cases of breast cancer among subjects with documented dietary habits. Incident cases of breast cancer as found by linkage with state cancer registries will allow calculation of hazard ratios comparing extreme quintiles of dietary intakes. The focus is on meats, soy, and dairy intakes. Linkage with state cancer registries occurs periodically for 9 years, with first linkage at year 04 of study enrolment.
Secondary Incident cases of prostate cancer among subjects with documented dietary intakes. Incident cases of prostate cancer as found by linkage with state cancer registries will allow calculation of hazard ratios comparing extreme quintiles of dietary intakes. The focus is on meats, soy, and dairy intakes. Linkage with state cancer registries occurs periodically for 9 years, with first linkage at year 04 of study enrolment.
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