AHS-2: Plant-based Diets and Risk of Cancer in the Adventist Health Study-2

Sponsor
Loma Linda University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03615599
Collaborator
National Cancer Institute (NCI) (NIH), World Cancer Research Fund International (Other), Ardmore Institute of Health (Other)
96,000
1
275
349.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    96000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cancer Epidemiology in Seventh-day Adventists
    Actual Study Start Date :
    Feb 1, 2002
    Actual Primary Completion Date :
    Dec 31, 2013
    Anticipated Study Completion Date :
    Dec 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Incident cases of breast cancer among subjects with documented dietary habits. [Linkage with state cancer registries occurs periodically for 9 years, with first linkage at year 04 of study enrolment.]

      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.

    Secondary Outcome Measures

    1. Incident cases of prostate cancer among subjects with documented dietary intakes. [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.

    Other Outcome Measures

    1. Incident cases of colorectal cancer among subjects with documented dietary habits. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Loma Linda University Loma Linda California United States 92350

    Sponsors and Collaborators

    • Loma Linda University
    • National Cancer Institute (NCI)
    • World Cancer Research Fund International
    • Ardmore Institute of Health

    Investigators

    • Principal Investigator: Gary E Fraser, MD,PhD, Loma Linda University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Loma Linda University
    ClinicalTrials.gov Identifier:
    NCT03615599
    Other Study ID Numbers:
    • 48134
    • U01CA152939
    • R01CA094594
    First Posted:
    Aug 6, 2018
    Last Update Posted:
    Nov 11, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Loma Linda University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 11, 2021