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FY2016 REFERRAL GUIDELINES: THE OFFICE OF DIETARY SUPPLEMENTS (ODS) RESEARCH SCHOLARS PROGRAM

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The Office of Dietary Supplements (ODS) Research Scholars Program is a 1-year competitive scholarship opportunity to study the role of dietary supplements in health promotion and disease prevention. This program is targeted towards early career scientists, including Tenure-Track Investigators, Early Independent Scientists, Assistant Clinical Investigators, Research Fellows, Staff Fellows, and Postdoctoral Fellows with at least 1 year of postdoctoral research experience. Senior Investigators, Senior Scientists, and Senior Clinicians are not eligible to apply. These referral guidelines have been prepared for use by NIH in determining projects within the scope of ODS, requirements for application submission, and expectations of funded scholars. For further information, please contact Dr. Cindy Davis.

Funding Opportunity Purpose

The mission of ODS is to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public to foster an enhanced quality of life and health for the U.S. population.

ODS supports all types of research including pre-clinical, clinical, behavioral, and epidemiological, in which the primary emphasis is the investigation of dietary supplements and/or their ingredients*. ODS research interests are not limited to specific health conditions, organ systems or populations groups.

[*As defined by Congress in the 1994 Dietary Supplement Health and Education Act, a dietary supplement is a product (other than tobacco) that is intended to supplement the diet; contains one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and other substances) or their constituents; and is intended to be taken by mouth as a pill, capsule, tablet, or liquid.]

Primary consideration for support will be given to proposals that stimulate dietary supplement research where it is lacking or lagging, clarify gaps, investigate the balance between benefits and risks where data are in conflict, target special population groups where additional science on supplements is needed, and focus on the use of supplements in improving or maintaining health and reducing the risk of chronic disease.

Due to constrained budgets, ODS mission-relevant research will be focused on the above areas. For FY2016, ODS will not entertain grants that have disease treatment as a focus.

Examples of research projects that fall within the mission of ODS include but are not limited to:

  • Evidence-based evaluations of the role of dietary supplements, including evaluation of the safety and efficacy of supplement use in the prevention and reduction of risks for chronic diseases.

  • Intervention studies that examine the effects of dietary supplements on maintenance of optimal health or reduction of disease risk where supplement interventions alter physiological endpoints or health outcomes (e.g., a study that examines the physiologic or mechanistic effects of St. John’s wort on depression, or a study assessing the effects of calcium supplements on bone mineral density and the reduced risk of osteoporosis).

  • Observational studies that examine the association between intakes of nutrients or other supplement ingredients and disease risk, physiological endpoints, or health outcomes. These would include studies that use food frequency questionnaires, diet recalls, diet records, diet histories, diet surveys, and other dietary assessment methods (e.g., a study that uses a food frequency questionnaire to analyze associations between intakes of vitamin E and phytoestrogens and breast cancer risk).

  • Studies that focus on the beneficial or adverse interactions of dietary supplements with foods, drugs, and other dietary supplements in healthy people and people with conditions in which these interactions may affect disease prevention, risk reduction, or the promotion of health and well-being.

  • Studies that investigate isolated bioactive compounds from foods to determine their safety or effect on disease risk, physiological endpoints, or health outcomes, even if they are not currently available as dietary supplements (e.g., a study to investigate bioactive compounds in human milk that are involved in infant growth and development or a study to investigate the safety of phytochemicals from mushrooms or their effects on host immunity or metabolism).

  • Studies that examine the safety, form, or bioavailability of dietary supplements (e.g., a rodent study to examine the safety of high intakes of vitamin A, a human study to examine the bioavailability of various forms of folic acid, or a clinical trial to examine the safety and side effects of various doses of saw palmetto).

  • Studies that delineate how dietary supplements moderate, alter, or enhance metabolic, physiological, or psychological processes associated with maintenance of optimal health and performance during the life cycle.

  • Studies of single ingredients or complex mixtures that examine the transport, metabolism, mechanism of action, associated enzymes, binding sites, regulatory mechanisms, or excretion to elucidate their physiological or biochemical role (e.g., a study to investigate the transport and metabolism of orally administered folic acid or a study to evaluate the mechanism of action of various components in Panax ginseng).

  • Research to develop, evaluate, optimize, or validate analytical methods for verifying ingredient identity and quantifying declared ingredients in raw materials and finished dietary supplement products.

Examples of research projects that typically fall outside the scope of ODS include:

  • Studies that administer the supplement intervention with the sole intent to treat a disease process or outcome, such as atherosclerosis or depression, without evaluation of the supplement’s effect on the underlying mechanism of action, bioavailability, or elucidation of metabolic pathways.

  • Human, animal, or laboratory studies that only correlate physiological levels of dietary supplements, their metabolites, or marker compounds with disease risk, physiological endpoints, or health outcomes without the administration of a dietary supplement (e.g., a human study correlating serum levels of 25-hydroxyvitamin D and risk of hip fracture or a human study correlating serum levels of folate and cardiovascular disease).

  • Studies evaluating the effect of whole foods that could be considered "functional foods" such as broccoli and other cruciferous vegetables, garlic, soy, and flaxseed. However, if a food ingredient in a defined form is being investigated (e.g., a garlic capsule, a soy or phytoestrogen supplement, or epigallocatechin gallate (EGCG) in a green tea supplement, or dried ginger root in a tea bag), then the study would be within the scope of ODS.

  • Studies that involve dietary ingredients used to treat inborn errors of metabolism (e.g., a study investigating the use of tyrosine to treat phenylketonuria). However, if the research is focused on the mechanism of action, it could be considered within scope.

  • Studies of compounds that are classified as drugs, such as the hormones estrogen, progesterone, and insulin.

Key Dates

May 3, 2016   Letter of intent submitted to Dr. Cindy Davis
May 13, 2016   Notification by ODS of whether or not the applicant is encouraged to
  submit a full proposal
June 14, 2016   Full applications submitted to Dr. Cindy Davis
July 13, 2016   Proposal review
July 20, 2016   Notification of ODS funding decision
Fall, 2017   Participation in ODS Scholars Symposium, if applicant is funded

Requirements for Application Submission

A. General Guidelines

  1. Support is available for a variety of types of NEW projects including pilot or feasibility studies, collection of preliminary data, secondary data analysis of existing data, small self-contained research projects, or development of new research technology. ODS co-funding is intended to stimulate new avenues of research within the NIH.

  2. ODS funding of intramural projects is designed for research projects that can be carried out in a short period of time with limited resources.

  3. Projects are generally limited to 1 year of funding and cannot exceed $100,000. Funds can be spent in FY16 or FY17. Funds can be used for supplies, equipment, and analyses. ODS funding is not meant to replace salary support currently being provided through an NIH stipend.

  4. The proposal should be written by the scholar candidate.

  5. Projects submitted for ODS co-funding should be within the Guidelines for the Conduct of Researchexternal link disclaimer.

  6. For studies investigating dietary supplements and/or supplement ingredients, the supplement should be administered in physiologically relevant forms and concentrations, and must be ingested in the oral form for clinical studies.

  7. In studies employing dietary assessments or surveys, questions about dietary supplement use must be included and the survey instruments should be validated.

  8. A rationale for how the proposed research fits within the mission of the ODS should be included.

  9. Investigators conducting clinical studies must contact the FDA to determine if an Investigational New Drug (IND) application is needed.

  10. Information demonstrating that the dietary supplement adheres to the National Center for Complementary and Integrative Health (NCCIH) Policy for Natural Products Integrity (an ODS summary of the policy is provided for your reference) will be required prior to funding. Additional requirements for clinical trials, animal studies, and probiotics can be found hereexternal link disclaimer.

  11. For studies that measure 25(OH)D, the Principal Investigator will be required to use National Institute of Standards and Technology (NIST) standard reference materialsexternal link disclaimer and is encouraged to participate in the NIST Vitamin D Metabolites Quality Assurance Programexternal link disclaimer. For large clinical trials, it is also recommended that the laboratory making the measurement participate in CDC’s Vitamin D Certification Programexternal link disclaimer.

  12. Analytic methods must be adequately described and must be demonstrated to be scientifically valid and suitable for their intended purpose.

  13. Applications will not be accepted without approval of the letter of intent.

B. Letter of Intent (Must be received by 5:00 pm on May 3, 2016)

  • Limited to one-page description of project and relevance to ODS mission. A letter from your Scientific Director indicating approval to submit should also be included.

C. Submission Materials (Must be received by 5:00 pm on June 14, 2016):

  1. Intramural requests for support should include a description of the Research Plan, not to exceed 10 pages, including tables, graphs, figures, and diagrams and charts. This will be critically reviewed for rigor and transparency.

    The Research Plan should include:
     
    • Introduction (one-page limit). Describe how this proposed study supports the ODS mission. What is the hypothesis under investigation?

    • Background and significance. Applicants should consider the scientific premise of the proposed research including a discussion of strengths and weaknesses of prior research crucial to support the application.

    • Clearly defined specific aims. Preliminary studies (if available).

    • Experimental design and methods proposed and how they will achieve robust and unbiased results. Specific details should include:

      • Statistical procedures used to determine appropriate group sizes

      • Plans for data analysis

      • Methods to reduce bias

        • Procedures to ensure independent, blinded measurements

        • Procedures to improve precision and minimize variability

        • Methods for randomization

      • Subject inclusion and exclusion criteria

      • Plans to address loss to follow-up and missing data

      • The chemical/biological composition and standardization of the intervention (dietary supplement as well as experimental diets)

      • Relevant biological variables, such as sex
  2. Supporting documents, in addition to the 10-page Research Plan, should include:
    • Abstract

    • Budget

    • Biosketches of the Principal Investigator (scholar candidate) and mentor

    • Training Plan, for applicants who are not Principal Investigators—not to exceed two pages (excluding publications). The candidate and the mentor are jointly responsible for the preparation of the training plan. The systematic plan must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the young scientist’s career goals. The sponsor/mentor may form an advisory committee to assist with the development of a program of study or to monitor the candidate’s progress through the training. The training plan should include:

      • Candidate’s objectives and long term career goals.

      • A description of candidate's prior training and how it relates to candidate’s objectives and long term career plans.

      • A description of candidate’s professional responsibilities in his/her current NIH research position.

      • A description of candidate’s research efforts to date, including any publications, prior research interests and experience.

      • A statement of how the proposed new training and research experience logically evolves from prior training and experience and how it will facilitate the young scientist’s transition to independent investigator status.

      • Mentor’s description of his/her oversight role in the training experience as well as expectations and deliverables for the trainee.

      • Also note if other mentors will be engaged in the trainee’s research.

      • A timeline is helpful.

      • An explanation of how research and educational resources of the institution will be utilized to promote candidate’s independence.
    • Appropriate product integrity information, as well as any additional material related to the authentication of key biological and/or chemical resources.
  3. Cover letter containing the signatures of the scholar, mentor, division or branch chief, and Institute or Center (IC) scientific director or IC director. For submission from an applicant who is not a Principal Investigator, include a letter of approval form the applicant’s Principal Investigator.

Expectations of Funded Scholars

  1. Present your research findings at the ODS Scholars Symposium, which will occur in the fall of 2017 (date to be determined);

  2. Acknowledge that ODS has co-funded the project; the Principal Investigator should acknowledge such co-funding in any publications, reports or presentations resulting from the award;

  3. Provide ODS with copies of any abstracts or publications pursuant to the work encompassed by the co-funding award;

  4. File a final report within 6 months of project completion;

  5. Participate in the Dietary Supplement Scientific Interest Group.

Minimum Criteria: Assessment of Dietary Supplement Ingredient Integrity

(Adapted from NCCIH Guidance on Biologically Active Agents)

  1. For botanicals, the complete taxonomic/scientific name along with the common name and source of the plant material/extract/phytochemical.

  2. Identify the manufacturer or distributor (if any) by name and address and contact information along with product brand name, if applicable.

  3. State the constituent(s), if any, to which the product is standardized.

  4. For non-botanical ingredients a full description is required. This should include brand name (if given), chemical purity (and methodology determined), and isomeric purity. Lot-specific or batch-specific certificates of analysis from the manufacturer are acceptable.

  5. Characterize the supplement composition (ingredient content and quantity), including laboratory analysis to confirm information on the certificate of analysis, if applicable.

  6. Provide documentation that demonstrates stability of ingredients for at least the duration of the study and explain how the product will be monitored for stability throughout the project period.

  7. Provide documentation that demonstrates reproducibility of product characteristics, especially if more than one batch is used in the study.

  8. Assure that the product is free of impurities (accidental or deliberate), e.g., pesticides, drugs, microbes, or metals.

  9. If the product is administered via a vehicle other than a tablet/capsule, provide information on the source and composition of the vehicle (diet, etc.) and assure that the ingredient or intervention remains stable and bioavailable (e.g., probiotic added to porridge, EGCG added to animal diet) throughout the study.

  10. For placebo, verify that the product matches the test agent on sensory characteristics, that the sensory characteristics are stable, and that the product contains no bioactive materials.

Reference Resources

2015 Funded ODS Scholars

IC: NCI
Scholar: Srujana Golla
Mentor: Frank Gonzalez
Title: The physiological assessment of St. John's wort dietary supplementation for systems level understanding of inflammatory bowel disease molecular mechanisms

IC: NHLBI
Scholar: Zhi-Hong Yang
Mentors: Alan Ramaley
Title: Effect of long-chain monounsaturated fatty acid (LCMUFA)-rich fish oil supplementation on lipid and lipoprotein metabolism

IC: NIAID
Scholar: Vanessa Ridaura
Mentor: Yasmine Belkaid
Title: Role of vitamin C in altering skin microbiota: implications for skin inflammatory disorders

IC: NIDDK
Scholar: Moon-Suhn Ryu
Mentors: Caroline Philpott
Title: Poly rC-binding proteins and Ncoa4 control the flux of iron through ferritin in developing red blood cells

2014 Funded ODS Scholars

IC: NCI
Scholar: Matthew Thompson
Mentor: Frank Gonzalez
Title: Selenium supplementation in asbestos exposed individuals: Selenium metabolism and lung cancer risk

IC: NIAID
Scholar: Benjamin Chaigne-Delalande
Mentors: Michael J. Lenardo, Koneti Rao, Sally Hunsberger
Title: Effect of dietary magnesium supplementation on the immune system of healthy adult subjects

IC: NIAID
Scholar: Timothy Hand
Mentor: Yasmine Belkaid
Title: Iron supplementation and commensal bacterial dysbiosis in the context of mucosal inflammation

IC: NIAMS
Scholar: Daniella Schwartz
Mentors: John O'Shea, Hong-Wei Sun
Title: Retinoic acid and T cells: A genomic and functional approach to prove disparate effects

IC: NIDCR
Scholar: Cheryl Chia
Mentor: Wanjun Chen
Title: The mechanisms of D-mannose in induction of regulatory T cells and prevention of autimmune disease

IC: NIEHS
Scholar: Katie M. O'Brien
Mentors: Clarice R. Weinberg, Dale P. Sandler, Jack A. Taylor
Title: The joint effects of vitamin D, genetics, and epigenetics in the prevention of breast cancer

Contact Information

Direct inquiries and submit requests regarding the ODS Scholars Programs to:
Dr. Cindy D. Davis, Ph.D.
Director of Grants and Extramural Activities
davisci@mail.nih.gov
301-496-0168