Whole Grain Intake and Cardiovascular Disease and Whole Grain Intake and Diabetes a Review
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The distribution or electronic posting of the PDF file is strictly prohibited without written permission of the Life Sciences Research Office LSRO WHOLE GRAIN INTAKE AND CARDIOVASCULAR DISEASE AND WHOLE GRAIN INTAKE AND DIABETES A REVIEW November 2008 Fabiana F. De Moura, Ph.D. Editor Sponsor: Kellogg Company Battle Creek, MI 49016 Life Sciences Research Office 9650 Rockville Pike Bethesda, Maryland 20814 www.LSRO.org The distribution or electronic posting of the PDF file is strictly prohibited without written permission of the Life Sciences Research Office WHOLE GRAIN INTAKE AND CARDIOVASCULAR DISEASE AND WHOLE GRAIN INTAKE AND DIABETES A REVIEW November, 2008 Fabiana F. De Moura, Ph.D. Editor Prepared for Kellogg Company, Battle Creek, MI 49016 Life Sciences Research Office 9650 Rockville Pike Bethesda, Maryland 20814 www.LSRO.org The distribution or electronic posting of the PDF file is strictly prohibited without written permission of the Life Sciences Research Office Review of Whole Grain Intake in Cardiovascular Disease and Diabetes Copyright © 2008 Life Sciences Research Office No part of this document may be reproduced by any mechanical, photographic, or electronic process, or in form of a phonographic recording, nor may it be stored in a retrieval system, transmitted, or otherwise copied for public or private use, without written permission from the publisher, except for the purposes of official use by the U.S. Government. Copies of the publication may be obtained from the Life Sciences Research Office. Orders and inquiries may be directed to: LSRO, 9650 Rockville Pike, Bethesda, MD 20814-3998. Tel: 301-634-7030; Fax 301-634-7876; web site: www.LSRO.org ISBN: 978-0-9795902-1-4 Library of Congress Catalog Number: 2008941165 i The distribution or electronic posting of the PDF file is strictly prohibited without written permission of the Life Sciences Research Office Review of Whole Grain Intake in Cardiovascular Disease and Diabetes FOREWORD The Life Sciences Research Office, Inc., (LSRO) provides scientific assessments of topics in the biomedical sciences. Reports published by LSRO are based on comprehensive literature reviews and the scientific opinions of knowledgeable investigators engaged in work in relevant areas of science and medicine. This report was developed under a contract between the Kellogg Company and LSRO. The findings, conclusions, and recommendations contained in this report were developed independently of the Kellogg Company and are not intended to represent the views of the Kellogg Company or any of its employees. An Expert Panel provided scientific oversight and direction for this study. LSRO independently appointed members of the Expert Panel on the basis of their qualifications, experience, judgment, and freedom from conflict of interest, with due considerations for balance and breadth in the appropriate professional disciplines. Panel members were selected with the concurrence of the LSRO Board of Directors. Biographical and professional information on members of the Expert Panel is provided in Appendix I. Fabiana DeMoura, Ph.D. drafted this report on the basis of available information and the deliberations and recommendations of the Expert Panel. The Kellogg Company provided a limited review of the report to assure factual accuracy and contractual conformance. The LSRO Board of Directors reviewed and approved the final report. Upon approval, LSRO published the report with no additional input or review. Participation in the preparation of this report or membership on the Expert Panel, or the LSRO Board of Directors, does not imply endorsement of all statements in the report. LSRO accepts full responsibility for the study conclusions and accuracy of the report. Michael Falk, Ph.D. Executive Director Life Sciences Research Office, Inc. November 5, 2008 ii The distribution or electronic posting of the PDF file is strictly prohibited without written permission of the Life Sciences Research Office Review of Whole Grain Intake in Cardiovascular Disease and Diabetes WHOLE GRAIN INTAKE AND CARDIOVASCULAR DISEASE AND WHOLE GRAIN INTAKE AND DIABETES A REVIEW TABLE OF CONTENTS FOREWORD ..............................................................................................................................................................II EXECUTIVE SUMMARY...........................................................................................................................................1 INTRODUCTION.........................................................................................................................................................4 WHOLE GRAINS DEFINITION ....................................................................................................................................4 HEALTH CLAIM REGULATIONS IN THE UNITED STATES ..........................................................................................4 Nutrition Labeling and Education Act of 1990 Health Claims .............................................................5 Food and Drug Administration Modernization Act of 1997 (FDAMA) Health Claims ....................6 WHOLE GRAINS AND FIBER .....................................................................................................................................7 WHOLE GRAINS COMPOSITION................................................................................................................................7 PROJECT PURPOSE................................................................................................................................................13 METHODOLOGY .....................................................................................................................................................14 INCLUSION CRITERIA ..............................................................................................................................................14 RESULTS ..................................................................................................................................................................15 INCLUDED STUDIES ................................................................................................................................................15 EXCLUDED STUDIES ...............................................................................................................................................15 INTERVENTION STUDIES ON CARDIOVASCULAR DISEASE.....................................................................................15 FDA Definition................................................................................................................................................16 Expanded Definition .....................................................................................................................................16 OBSERVATIONAL STUDIES ON CARDIOVASCULAR DISEASE ................................................................................22 FDA Definition................................................................................................................................................22 Expanded Definition .....................................................................................................................................23 Prospective Cohort Studies .................................................................................................................................... 23 Cross-Sectional Studies........................................................................................................................................... 25 INTERVENTION STUDIES ON DIABETES ..................................................................................................................31 FDA Definition................................................................................................................................................31 Expanded Definition .....................................................................................................................................32 Long Term Studies .................................................................................................................................................... 32 Acute Studies.............................................................................................................................................................. 33 OBSERVATIONAL STUDIES ON DIABETES..............................................................................................................38 FDA Definition................................................................................................................................................38 Expanded Definition .....................................................................................................................................38 Prospective Cohort Studies .................................................................................................................................... 38 Cross-Sectional Studies........................................................................................................................................... 40 DISCUSSION AND CONCLUSIONS ....................................................................................................................45 CARDIOVASCULAR DISEASE ..................................................................................................................................45