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FY2014 Referral Guidelines: The Office of Dietary Supplements (ODS) Research Scholars Program

Table of Contents

The Office of Dietary Supplements 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 or 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 the mission of the Office of Dietary Supplements (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.

Research interests of ODS are not limited to specific health conditions, organ systems or populations groups. 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.

[Note: 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; 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, and 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 FY2014, 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 other 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 mass density and the reduced risk of osteoporosis).

  • Observational studies that examine the association between intakes of nutrients or other substances from supplementation and disease risk, physiological endpoints or other 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 persons and those with selected conditions where 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 other 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 of dietary supplements in order 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 the 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 other health outcomes without the administration of a dietary supplement (e.g., a human study correlating serum levels of 25(OH) vitamin 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.” This would include 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, EGCG in a green tea supplement, or dried ginger root in a tea bag), then the study would be within the scope of the ODS mission.

  • Studies that involve dietary ingredients used to treat inborn errors of metabolism, such as 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 2, 2014: Letter of intent submitted to Dr. Cindy Davis

May 12, 2014: Notification of whether or not the applicant is encouraged to submit a full proposal

June 23, 2014: Full applications submitted to Dr. Cindy Davis

July 16, 2014: Proposal review

July 28, 2014: Notification of funding decision

Fall, 2015: Participation in ODS Scholars Symposium

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 one year of funding and cannot exceed $100,000. Funds can be spent in FY14 and FY15. 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 must be written by the scholar candidate.
  5. Projects submitted for ODS co-funding must be within the Guidelines for the Conduct of Research in the Intramural Research Program at NIHexternal link icon.
  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 (see ODS Strategic Plan Goals).
  9. Investigators conducting clinical studies must contact the FDA to determine if an Investigational New Drug (IND) is needed.
  10. Information demonstrating that the dietary supplement adheres to the NCCAM Policy for Natural Products Integrityexternal link icon (see Minimum Criteria: Assessment of Dietary Supplement Ingredient Integrity) will be required prior to funding. Additional requirements for clinical trials, animal studies and probiotics can be found hereexternal link icon.
  11. For studies that measure 25(OH)D, the Principal Investigator will be required to use National Institute of Standards and Technologyexternal link icon (NIST) standard reference materials and are encouraged to participate in the NIST Vitamin D Metabolites Quality Assurance Programexternal link icon. For large clinical trials, it is also recommended that the laboratory making the measurement participate in CDC’s Vitamin D Certification Programexternal link icon.
  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 2, 2014)

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

C. Submission Materials (Must be received by 5:00 pm on June 23, 2014):
  1. Intramural requests for support must include a description of the Research Plan, not to exceed 10 pages, including tables, graphs, figures, and diagrams and charts.

    The Research Plan should include:
    • Introduction (one page limit): Describe how this proposed study supports the ODS mission Hypothesis under investigation.
    • Background and significance.
    • Clearly defined specific aims. Preliminary studies (if available).
    • Research design and methods to include specific details on the chemical/biological composition and standardization of the intervention (dietary supplement as well as experimental diets).
  2. Supporting documents, in addition to the 10-page Research Plan, should include:
    • Budget.
    • Biosketches for 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 must include:
      1. Candidate’s objectives and long term career goals.
      2. A description of candidate's prior training and how it relates to candidate’s career objectives and long term career plans.
      3. A description of candidate’s professional responsibilities in his/her current NIH research position.
      4. A description of candidate’s research efforts to date, including publications, prior research interests, and experience.
      5. 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.
      6. Mentor’s description of his/her oversight role in the training experience as well as expectations and deliverables for the trainee.
      7. Also note if other mentors will be engaged in the trainee’s research.
      8. A timeline is helpful.
      9. An explanation of how research and educational resources of the institution will be used to promote candidate’s independence.
    • Appropriate product integrity information (see here).
  3. Cover letter containing the signatures of the scholar, mentor, division or branch chief and 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

A. Present their research findings at the ODS Scholars Symposium, which will occur in the fall of 2015 (date to be determined).
B. Acknowledgement that ODS has co-funded the project and that the Principal Investigator must acknowledge such co-funding in any publications, reports, or presentations resulting from the award.
C. ODS must be provided with copies of any abstracts or publications pursuant to the work encompassed by the co-funding award.
D. A final report be filed within six months of project completion.
E. Participation in the ODS Dietary Supplement Research Practicum.
F. Participation in the Dietary Supplement Scientific Interest Group.

Minimum Criteria: Assessment of Dietary Supplement Ingredient Integrity

(Adapted from NCCAM Guidance on Biologically Active Agents)
  • For botanicals, provide the correct, complete taxonomic/scientific name along with the common name.
  • For non-botanical ingredients, a full description is required. This should include brand name (if given), chemical purity (and method used to determine it), and isomeric purity.
  • Identify the manufacturer or distributor (if any) by name and address and contact information along with product brand name, if applicable.
  • State the constituent(s) to which the product is standardized.
  • Characterize the supplement composition (ingredient content and quantity), if applicable.
  • 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.
  • Provide documentation that demonstrates reproducibility of product characteristics, especially if more than one batch is used in the study.
  • Assure that the product is free of impurities (accidental or deliberate), e.g., pesticides, drugs, microbes, or metals.
  • If the product is administered via a vehicle other than a tablet/capsule, assure that the characteristics remain stable and bioavailable (e.g., probiotic added to porridge, EGCG added to rat food).
  • 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 bioactives.
  • In general, assure that the investigator will be able to appropriately describe the intervention in publications as described in Gagnier et alexternal link icon.

Reference Resources