The polyp prevention trial-continued follow-up study: No effect of a low-fat, high-fiber, high-fruit, and -vegetable diet on adenoma recurrence eight years after randomization

Elaine Lanza, Binbing Yu, Gwen Murphy, Paul S. Albert, Bette Caan, James R. Marshall, Michael P Lance, Electra D. Paskett, Joel Weissfeld, Marty Slattery, Randall Burt, Frank Iber, Moshe Shike, James W. Kikendall, Brenda K. Brewer, Arthur Schatzkin

Research output: Contribution to journalArticle

66 Citations (Scopus)

Abstract

The Polyp Prevention Trial (PPT) was a multicenter randomized clinical trial to evaluate the effects of a high-fiber (18 g/1,000 kcal), high-fruit and -vegetable (3.5 servings/1,000 kcal), and low-fat (20% of total energy) diet on the recurrence of adenomatous polyps in the large bowel over a period of 4 years. Although intervention participants reported a significantly reduced intake of dietary fat, and increased fiber, fruit, and vegetable intakes, their risk of recurrent adenomas was not significantly different from that of the controls. Since the PPT intervention lasted only 4 years, it is possible that participants need to be followed for a longer period of time before treatment differences in adenoma recurrence emerge, particularly if diet affects early events in the neoplastic process. The PPT-Continued Follow-up Study (PPT-CFS) was a postintervention observation of PPT participants for an additional 4 years from the completion of the trial. Of the 1,905 PPT participants, 1,192 consented to participate in the PPT-CFS and confirmed colonoscopy reports were obtained on 801 participants. The mean time between the main trial end point colonoscopy and the first colonoscopy in the PPT-CFS was 3.94 years (intervention group) and 3.87 years (control group). The baseline characteristics of 405 intervention participants and 396 control participants in the PPT-CFS were quite similar. Even though the intervention group participants increased their fat intake and decreased their intakes of fiber, fruits, and vegetables during the PPT-CFS, they did not go back to their prerandomization baseline diet (P < 0.001 from paired t tests) and intake for each of the three dietary goals was still significantly different from that in the controls during the PPT-CFS (P < 0.001 from t tests). As the CFS participants are a subset of the people in the PPT study, the nonparticipants might not be missing completely at random. Therefore, a multiple imputation method was used to adjust for potential selection bias. The relative risk (95% confidence intervals) of recurrent adenoma in the intervention group compared with the control group was 0.98 (0.88-1.09). There were no significant intervention-control group differences in the relative risk for recurrence of an advanced adenoma (1.06; 0.81-1.39) or multiple adenomas (0.92; 0.77-1.10). We also used a multiple imputation method to examine the cumulative recurrence of adenomas through the end of the PPT-CFS: the intervention-control relative risk (95% confidence intervals) for any adenoma recurrence was 1.04 (0.98-1.09). This study failed to show any effect of a low-fat, high-fiber, high-fruit and -vegetable eating pattern on adenoma recurrence even with 8 years of follow-up.

Original languageEnglish (US)
Pages (from-to)1745-1752
Number of pages8
JournalCancer Epidemiology Biomarkers and Prevention
Volume16
Issue number9
DOIs
StatePublished - Sep 1 2007

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Random Allocation
Polyps
Vegetables
Adenoma
Fruit
Fats
Diet
Recurrence
Colonoscopy
Control Groups
Confidence Intervals
Adenomatous Polyps
Neoplastic Processes
Selection Bias
Dietary Fats
Randomized Controlled Trials
Eating
Observation

ASJC Scopus subject areas

  • Epidemiology
  • Oncology

Cite this

The polyp prevention trial-continued follow-up study : No effect of a low-fat, high-fiber, high-fruit, and -vegetable diet on adenoma recurrence eight years after randomization. / Lanza, Elaine; Yu, Binbing; Murphy, Gwen; Albert, Paul S.; Caan, Bette; Marshall, James R.; Lance, Michael P; Paskett, Electra D.; Weissfeld, Joel; Slattery, Marty; Burt, Randall; Iber, Frank; Shike, Moshe; Kikendall, James W.; Brewer, Brenda K.; Schatzkin, Arthur.

In: Cancer Epidemiology Biomarkers and Prevention, Vol. 16, No. 9, 01.09.2007, p. 1745-1752.

Research output: Contribution to journalArticle

Lanza, E, Yu, B, Murphy, G, Albert, PS, Caan, B, Marshall, JR, Lance, MP, Paskett, ED, Weissfeld, J, Slattery, M, Burt, R, Iber, F, Shike, M, Kikendall, JW, Brewer, BK & Schatzkin, A 2007, 'The polyp prevention trial-continued follow-up study: No effect of a low-fat, high-fiber, high-fruit, and -vegetable diet on adenoma recurrence eight years after randomization', Cancer Epidemiology Biomarkers and Prevention, vol. 16, no. 9, pp. 1745-1752. https://doi.org/10.1158/1055-9965.EPI-07-0127
Lanza, Elaine ; Yu, Binbing ; Murphy, Gwen ; Albert, Paul S. ; Caan, Bette ; Marshall, James R. ; Lance, Michael P ; Paskett, Electra D. ; Weissfeld, Joel ; Slattery, Marty ; Burt, Randall ; Iber, Frank ; Shike, Moshe ; Kikendall, James W. ; Brewer, Brenda K. ; Schatzkin, Arthur. / The polyp prevention trial-continued follow-up study : No effect of a low-fat, high-fiber, high-fruit, and -vegetable diet on adenoma recurrence eight years after randomization. In: Cancer Epidemiology Biomarkers and Prevention. 2007 ; Vol. 16, No. 9. pp. 1745-1752.
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T2 - No effect of a low-fat, high-fiber, high-fruit, and -vegetable diet on adenoma recurrence eight years after randomization

AU - Lanza, Elaine

AU - Yu, Binbing

AU - Murphy, Gwen

AU - Albert, Paul S.

AU - Caan, Bette

AU - Marshall, James R.

AU - Lance, Michael P

AU - Paskett, Electra D.

AU - Weissfeld, Joel

AU - Slattery, Marty

AU - Burt, Randall

AU - Iber, Frank

AU - Shike, Moshe

AU - Kikendall, James W.

AU - Brewer, Brenda K.

AU - Schatzkin, Arthur

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N2 - The Polyp Prevention Trial (PPT) was a multicenter randomized clinical trial to evaluate the effects of a high-fiber (18 g/1,000 kcal), high-fruit and -vegetable (3.5 servings/1,000 kcal), and low-fat (20% of total energy) diet on the recurrence of adenomatous polyps in the large bowel over a period of 4 years. Although intervention participants reported a significantly reduced intake of dietary fat, and increased fiber, fruit, and vegetable intakes, their risk of recurrent adenomas was not significantly different from that of the controls. Since the PPT intervention lasted only 4 years, it is possible that participants need to be followed for a longer period of time before treatment differences in adenoma recurrence emerge, particularly if diet affects early events in the neoplastic process. The PPT-Continued Follow-up Study (PPT-CFS) was a postintervention observation of PPT participants for an additional 4 years from the completion of the trial. Of the 1,905 PPT participants, 1,192 consented to participate in the PPT-CFS and confirmed colonoscopy reports were obtained on 801 participants. The mean time between the main trial end point colonoscopy and the first colonoscopy in the PPT-CFS was 3.94 years (intervention group) and 3.87 years (control group). The baseline characteristics of 405 intervention participants and 396 control participants in the PPT-CFS were quite similar. Even though the intervention group participants increased their fat intake and decreased their intakes of fiber, fruits, and vegetables during the PPT-CFS, they did not go back to their prerandomization baseline diet (P < 0.001 from paired t tests) and intake for each of the three dietary goals was still significantly different from that in the controls during the PPT-CFS (P < 0.001 from t tests). As the CFS participants are a subset of the people in the PPT study, the nonparticipants might not be missing completely at random. Therefore, a multiple imputation method was used to adjust for potential selection bias. The relative risk (95% confidence intervals) of recurrent adenoma in the intervention group compared with the control group was 0.98 (0.88-1.09). There were no significant intervention-control group differences in the relative risk for recurrence of an advanced adenoma (1.06; 0.81-1.39) or multiple adenomas (0.92; 0.77-1.10). We also used a multiple imputation method to examine the cumulative recurrence of adenomas through the end of the PPT-CFS: the intervention-control relative risk (95% confidence intervals) for any adenoma recurrence was 1.04 (0.98-1.09). This study failed to show any effect of a low-fat, high-fiber, high-fruit and -vegetable eating pattern on adenoma recurrence even with 8 years of follow-up.

AB - The Polyp Prevention Trial (PPT) was a multicenter randomized clinical trial to evaluate the effects of a high-fiber (18 g/1,000 kcal), high-fruit and -vegetable (3.5 servings/1,000 kcal), and low-fat (20% of total energy) diet on the recurrence of adenomatous polyps in the large bowel over a period of 4 years. Although intervention participants reported a significantly reduced intake of dietary fat, and increased fiber, fruit, and vegetable intakes, their risk of recurrent adenomas was not significantly different from that of the controls. Since the PPT intervention lasted only 4 years, it is possible that participants need to be followed for a longer period of time before treatment differences in adenoma recurrence emerge, particularly if diet affects early events in the neoplastic process. The PPT-Continued Follow-up Study (PPT-CFS) was a postintervention observation of PPT participants for an additional 4 years from the completion of the trial. Of the 1,905 PPT participants, 1,192 consented to participate in the PPT-CFS and confirmed colonoscopy reports were obtained on 801 participants. The mean time between the main trial end point colonoscopy and the first colonoscopy in the PPT-CFS was 3.94 years (intervention group) and 3.87 years (control group). The baseline characteristics of 405 intervention participants and 396 control participants in the PPT-CFS were quite similar. Even though the intervention group participants increased their fat intake and decreased their intakes of fiber, fruits, and vegetables during the PPT-CFS, they did not go back to their prerandomization baseline diet (P < 0.001 from paired t tests) and intake for each of the three dietary goals was still significantly different from that in the controls during the PPT-CFS (P < 0.001 from t tests). As the CFS participants are a subset of the people in the PPT study, the nonparticipants might not be missing completely at random. Therefore, a multiple imputation method was used to adjust for potential selection bias. The relative risk (95% confidence intervals) of recurrent adenoma in the intervention group compared with the control group was 0.98 (0.88-1.09). There were no significant intervention-control group differences in the relative risk for recurrence of an advanced adenoma (1.06; 0.81-1.39) or multiple adenomas (0.92; 0.77-1.10). We also used a multiple imputation method to examine the cumulative recurrence of adenomas through the end of the PPT-CFS: the intervention-control relative risk (95% confidence intervals) for any adenoma recurrence was 1.04 (0.98-1.09). This study failed to show any effect of a low-fat, high-fiber, high-fruit and -vegetable eating pattern on adenoma recurrence even with 8 years of follow-up.

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