Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03615599
Recruitment Status : Active, not recruiting
First Posted : August 6, 2018
Last Update Posted : November 5, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
World Cancer Research Fund International
Ardmore Institute of Health
Information provided by (Responsible Party):
Gary Fraser, Loma Linda University

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
Cancer, Breast Cancer, Colorectal Cancer, Prostate

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.

Layout table for study information
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 : February 1, 2002
Actual Primary Completion Date : December 31, 2013
Estimated Study Completion Date : December 31, 2024

Group/Cohort
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.



Primary Outcome Measures :
  1. 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. ]
    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. [ 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.


Other Outcome Measures:
  1. 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.


Biospecimen Retention:   Samples With DNA
Buffy coat samples from a sample of the cohort (~2500) are stored from which DNA material may be extracted when a study requires such data. Other stored bio-specimens from a sample of the cohort include adipose tissue, urine, blood, sputum, stool.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 %).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615599


Locations
Layout table for location information
United States, California
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
Layout table for investigator information
Principal Investigator: Gary E Fraser, MD,PhD Loma Linda University
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Gary Fraser, Principal Investigator, Loma Linda University
ClinicalTrials.gov Identifier: NCT03615599    
Other Study ID Numbers: 48134
U01CA152939 ( U.S. NIH Grant/Contract )
R01CA094594 ( U.S. NIH Grant/Contract )
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: on-going
Access Criteria: Data access will be given upon approval of proposal by the AHS-2 Review Committee.
URL: http://www.ahs2.org

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gary Fraser, Loma Linda University:
Seventh-day Adventists
vegetarian
mortality
cancer
dietary pattern
soy consumption
dairy consumption
plant-based
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Colorectal Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Prostatic Diseases