This trial is active, not recruiting.

Condition healthy
Treatments modified consent form, standard consent form
Sponsor University of California, Davis
Collaborator National Center for Research Resources (NCRR)
Start date November 2007
End date September 2008
Trial size 30 participants
Trial identifier NCT00715923, 200715802


Subjects enrolling into a nutrition study of the effects of tea on fat absorption will be randomized to receive either a standard informed consent document or a modified document that is shorter and more easily understood than the standard document. The hypothesis is that using a shorter form that is more easily understood and more visually simple will lead to greater subject satisfaction in the consent process and will not compromise subject comprehension of key study aspects. Consent for study inclusion has been waived by the IRB because informing subjects of the nature and process of the study would likely affect the findings, and both the standard and modified consent forms were approved for use in the nutrition study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Modified consent form
modified consent form
modified consent form used
(Active Comparator)
Standard consent form
standard consent form
standard consent form used

Primary Outcomes

Subject satisfaction
time frame: close of parent study

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - participation in parent study, English speaking Exclusion Criteria: - none

Additional Information

Official title CTSA Utility of Modified Consent Forms in Clinical Research: Fraga Tea Study
Principal investigator Alexander A Kon, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by University of California, Davis.