CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,079 enrolled
Drug / intervention
low fat, high fiber, high fruit and vegetable eating planother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00339625
NCT00339625Phase 3Completed

Polyp Prevention Trial

National Cancer Institute (NCI)·interventional·Posted Jun 21, 2006·Updated May 15, 2020

In Brief

A Phase 3 clinical trial evaluating low fat, high fiber, high fruit and vegetable eating plan for Diet and 2 related conditions. Completed, enrolled 2,079 participants across 1 site.

Detailed Summary

The primary objective of the Poly Prevention Trial (PPT) is to determine whether a low fat, high fiber, high vegetable and fruit eating plan will decrease the recurrence of adenomatous polyps of the large bowel. Secondary objectives of the PPT include 1) evaluating the effectiveness of the intervention program with respect to participant achievement of dietary goals; 2) examining the relation of dietary change and biochemical markers in blood; and 3) assessing the impact of the intervention on quality of life indicators.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiet, Polyps, Adenoma
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
1991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 21, 2006
Enrollment StartJun 19, 1991
Primary CompletionMay 11, 2020
TodayJul 2, 2026
Enrollment to primary: 28.9 yearsPosted 20.0 years ago

Interventions

low fat, high fiber, high fruit and vegetable eating planother

Participants were randomized to a low fat, high fiber, high fruit and vegetable (intervention arm) or their usual diet (control arm)