Clinical trial NCT03615599: Plant-based Diets and Risk of Cancer in the Adventist Health Study-2
Official title: Cancer Epidemiology in Seventh-day Adventists
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer, Breast
Cancer, Colorectal
Cancer, Prostate
Keywords: Seventh-day Adventists
vegetarian
mortality
cancer
dietary pattern
soy consumption
dairy consumption
plant-based
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: World Cancer Research Fund International
name: Ardmore Institute of Health
First posted: 2018-08-06
Enrollment: 96000
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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 %).

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incident cases of breast cancer among subjects with documented dietary habits.
timeFrame: Linkage with state cancer registries occurs periodically for 9 years, with first linkage at year 04 of study enrolment.
Secondary outcomes:
measure: Incident cases of prostate cancer among subjects with documented dietary intakes.
timeFrame: Linkage with state cancer registries occurs periodically for 9 years, with first linkage at year 04 of study enrolment.
Other outcomes:
measure: Incident cases of colorectal cancer among subjects with documented dietary habits.
timeFrame: Linkage with state cancer registries occurs periodically for 9 years, with first linkage at year 04 of study enrolment.
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Gary E Fraser, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.