- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03615599
Plant-based Diets and Risk of Cancer in the Adventist Health Study-2 (AHS-2)
January 28, 2026 updated by: Loma Linda University
Cancer Epidemiology in Seventh-day Adventists
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.
Study Overview
Status
Active, not recruiting
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
96000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Loma Linda, California, United States, 92350
- Loma Linda University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
26 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The sample includes Seventh-day Adventist church members living in the USA and Canada who are 30 years and older, and who are sufficiently fluent in English to complete the lengthy lifestyle questionnaire.
The study population is about 65% female.
Approximately 25% of the cohort are Black/African Americans .
Other ethnic minorities (e.g.
Asian, Hispanic) are at much lower percentages (3-4 %).
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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Seventh-day Adventists
This is a prospective cohort study of 96,000 members of the Seventh-day Adventists Church in the United States and Canada age 30 and older at the time of enrollment who are proficient in English language.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incident cases of breast cancer among subjects with documented dietary habits.
Time Frame: Linkage with state cancer registries occurs periodically for 9 years, with first linkage at year 04 of study enrolment.
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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.
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Linkage with state cancer registries occurs periodically for 9 years, with first linkage at year 04 of study enrolment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incident cases of prostate cancer among subjects with documented dietary intakes.
Time Frame: Linkage with state cancer registries occurs periodically for 9 years, with first linkage at year 04 of study enrolment.
|
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.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incident cases of colorectal cancer among subjects with documented dietary habits.
Time Frame: Linkage with state cancer registries occurs periodically for 9 years, with first linkage at year 04 of study enrolment.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gary E Fraser, MD,PhD, Loma Linda University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Fraser GE, Jacobsen BK, Knutsen SF, Mashchak A, Lloren JI. Tomato consumption and intake of lycopene as predictors of the incidence of prostate cancer: the Adventist Health Study-2. Cancer Causes Control. 2020 Apr;31(4):341-351. doi: 10.1007/s10552-020-01279-z. Epub 2020 Feb 25.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2002
Primary Completion (Actual)
December 31, 2013
Study Completion (Estimated)
December 1, 2028
Study Registration Dates
First Submitted
June 29, 2018
First Submitted That Met QC Criteria
July 30, 2018
First Posted (Actual)
August 6, 2018
Study Record Updates
Last Update Posted (Actual)
January 30, 2026
Last Update Submitted That Met QC Criteria
January 28, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colonic Diseases
- Skin Diseases
- Breast Diseases
- Skin and Connective Tissue Diseases
- Neoplasms
- Prostatic Neoplasms
- Colorectal Neoplasms
- Breast Neoplasms
Other Study ID Numbers
- 48134
- U01CA152939 (U.S. NIH Grant/Contract)
- R01CA094594 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Researchers must write a proposal describing how the data will be used and submit it to the Adventist Health Study data sharing committee for approval.
IPD Sharing Time Frame
on-going
IPD Sharing Access Criteria
Data access will be given upon approval of proposal by the AHS-2 Review Committee.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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