Who is sponsoring NCT00339625?

NCT00339625 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT00339625?

Interventions in NCT00339625: low fat, high fiber, high fruit and vegetable eating plan.

What condition does NCT00339625 study?

NCT00339625 studies Diet, Polyps, Adenoma.

Is NCT00339625 still recruiting?

NCT00339625 is currently completed. Last updated 15 May 2020.

Last reviewed 2020-05-15 · How we verify

NCT00339625

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Polyp Prevention Trial

Completed Phase 3 Last updated 15 May 2020

What this trial tests

Phase 3 trial testing low fat, high fiber, high fruit and vegetable eating plan in Diet in 2,079 participants. Completed in 11 May 2020.

Timeline

19 June 1991

Primary endpoint
11 May 2020

11 May 2020

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	2,079
Start date	19 June 1991
Primary completion	11 May 2020
Estimated completion	11 May 2020
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

Diet — all drugs for Diet →
Polyps — all drugs for Polyps →
Adenoma — all drugs for Adenoma →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 35 to 99, any sex, with Diet or Polyps. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Identification and monitoring of metabolite markers of dry bean consumption in parallel human and mouse studies.
Perera T, Young MR, Zhang Z, Murphy G, et al · · 2015 · cited 33× · PMID 25641932 · DOI 10.1002/mnfr.201400847
Dietary fat and lipid metabolism in the tumor microenvironment.
Goswami S, Zhang Q, Celik CE, Reich EM, et al · · 2023 · cited 21× · PMID 37722512 · DOI 10.1016/j.bbcan.2023.188984
Circulating Bile Acids and Adenoma Recurrence in the Context of Adherence to a High-Fiber, High-Fruit and Vegetable, and Low-Fat Dietary Intervention.
Byrd DA, Gomez M, Hogue S, Murphy G, et al · · 2022 · cited 9× · PMID 36113023 · DOI 10.14309/ctg.0000000000000533
Effects of a high-fiber, high-fruit and high-vegetable, low-fat dietary intervention on the rectal tissue microbiome.
Byrd DA, Gomez M, Hogue S, Wan Y, et al · · 2025 · cited 2× · PMID 39980340 · DOI 10.1093/jnci/djaf034
Prospective and Cross-sectional Associations of the Rectal Tissue Microbiome with Colorectal Adenoma Recurrence.
Byrd DA, Vogtmann E, Ortega-Villa AM, Wan Y, et al · · 2023 · cited 2× · PMID 36525653 · DOI 10.1158/1055-9965.epi-22-0608

Verify or expand the search:

Other recruiting trials for Diet

Currently open trials in the same condition.

NCT06848491 — Using Tailored mHealth Strategies to Promote Weight Management Among Adolescent and Young Adult Cancer Survivors · NA · recruiting
NCT06955975 — The Effect of Pectin Supplementation on Geriatric With Frailty: A Randomised Placebo-Controlled Dietary Intervention Stu · NA · recruiting
NCT06735599 — Wild Blueberries for Gut, Brain, and Heart Health in Adults With High Blood Pressure · NA · recruiting
NCT06753682 — Healthy Plant-based Diet and Periodontal Treatment · NA · recruiting
NCT06152614 — MIND Foods and Aerobic Training in Black Adults With HTN · NA · recruiting

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem · Phase 1, PHASE2 · recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting
NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After · Phase 1 · not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00339625 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 15 May 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00339625.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing