NUTRIENT INFLUENCE ON GENE REGULATION AND EXPRESSION NIH GUIDE, Volume 21, Number 17, May 8, 1992 PA NUMBER: PA-92-77 P.T. 34 Keywords: Gene Regulation Nutrition/Dietetics Metabolism Biology, Molecular Biosynthesis Hormones National Institute of Diabetes and Digestive and Kidney Diseases National Heart Lung and Blood Institute National Institute of Child Health and Human Development PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Heart Lung and Blood Institute (NHLBI), and the National Institute of Child Health and Human Development (NICHD) are interested in receiving research grant applications for support of research on dietary factors that control or regulate specific molecular and genetic functions. Applications covering a broad range of activities in this area, including both basic and clinical research, are encouraged. It is expected that regardless of approach, all studies will be focused on normal and/or abnormal control of gene regulation and expression. This type of announcement is issued in order to encourage investigator-initiated research projects in these areas of special programmatic interest. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieve the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Nutrient Influence on Gene Regulation and Expression, is related to the priority areas focusing on the roles of specific dietary factors in the etiology and prevention of chronic diseases and obesity. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238) ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) Award (R29). Applications from minority individuals and women are encouraged. MECHANISMS OF SUPPORT Support of this program will be by research project grants (R01) and FIRST Awards (R29). RESEARCH OBJECTIVES The National Institutes of Health (NIH) supports basic and clinical studies related to the requirements, bioavailability, and metabolism of nutrients and other dietary components at the organ, cellular, and subcellular levels in normal and diseased states Specific areas of research interest include the understanding of the physiological, biochemical and molecular functions and mechanisms of action/interaction of nutrients within the body. This announcement is intended to stimulate research on dietary factors and related metabolic interactions that have direct or indirect nutrient influence on specific gene regulation and expression. This would require interdisciplinary efforts focusing on interactions of nutrition, molecular biology, and metabolism. Recent studies indicate that this is an emerging area, rich with opportunities, but in need of additional support for further development of research efforts It appears that nutritional factors, e.g., various vitamins regulated via dietary intake can interact with other regulatory networks, such as tissue-specific, developmental, and hormonal factors, as well as dietary fat or carbohydrate, to regulate gene expression. Other studies have demonstrated regulation of apoprotein gene expression by sucrose-rich diet, nutritional regulation of gene expression in lipogenesis, and suppression of fatty acid synthase transcription by polyunsaturated fatty acids. More advanced studies focus on dietary protein control of intestinal hormone gene expression. Significant regulation appears to be at the level of transcription, with controlled modulation of messenger RNA levels. However, basic mechanisms underlying the influence of dietary factors and related metabolites on gene transcription need further study. In addition to studies focusing on mechanisms controlling gene regulation by dietary factors, support is also needed for work on the interactions between genetic factors and nutrition. In particular, work is encouraged on mechanisms influenced by hyper- and hypo-responsiveness to diet. This may be critical in evaluating outcomes of dietary therapy regimens. Other, specific examples of research objectives appropriate for inclusion in applications responsive to this program announcement include: o studies on retinoic acid regulation of adipocyte gene expression; o studies of dietary antioxidant/oxidant factors that affect DNA structure and function; o studies on influence of cholesterol and triglyceride levels in regulation of LDL receptor gene and apolipoprotein gene expression in the liver and GI tract; o studies on nutrient control of lipoprotein lipase gene expression; o studies of factors that mediate the protein synthetic response to nutrient intake; o studies on interactions of vitamins and other dietary factors with nuclear receptors; o studies of gastrointestinal hormone gene regulation by specific nutrients; o studies of dietary factors controlling expression of transferrin receptor and other proliferation-related genes STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions that disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. Applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC program director or Principal Investigator must be included with the application. Application kits are available at most institutional business offices and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. The title and number of the announcement must be typed in line 2a on the face page of the application. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892 REVIEW PROCEDURES Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second- level review by an appropriate national advisory council or board. Applications for supplements to ongoing awards will be reviewed according to procedures applicable to the mechanism of the ongoing award. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Michael K. May, Ph.D. Director, Nutrient Metabolism Program Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A18A Bethesda, MD 20892 Telephone: (301) 496-7121 FAX: (301) 402-1278 Direct inquiries regarding fiscal matters to: Ms. Paulette Badman Grants Management Specialist Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 639 Bethesda, MD 20892 Telephone: (301) 496-7467 FAX: (301) 496-9721 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.837, 93.848, and 93.865. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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