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FY2018 REFERRAL GUIDELINES: THE OFFICE OF DIETARY SUPPLEMENTS (ODS) RESEARCH SCHOLARS PROGRAM

Table of Contents

The Office of Dietary Supplements (ODS) Research Scholars Program is a one-year competitive scholarship opportunity for NIH intramural scientists to study the role of dietary supplements and/or their ingredients 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 one year of postdoctoral research experience. All applicants must have obtained their terminal degree within the last 10 years. 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, identifying requirements for application submission, and describing the expectations of funded scholars. For further information, please contact Cindy Davis at davisci@mail.nih.gov. Information about previously funded ODS scholars can be found on the ODS website.

I. Purpose of Funding Opportunity

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.

Primary consideration for support will be given to proposals that stimulate dietary supplement research where it is lacking or lagging to clarify gaps, investigate the balance between health 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 and/or their ingredients in improving or maintaining health and reducing the risk of chronic disease.

Another ODS funding priority is to enhance collaborations between multidisciplinary researchers from different NIH laboratories or institutes. ODS encourages applications where the scholar would have the opportunity to learn and apply new methodology to his or her research.

Due to constrained budgets, ODS mission-relevant research will be focused on the above areas. For FY2018, ODS will not entertain grants that have disease treatment as a focus.



*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.?
 

Examples of research projects that fall within the mission of ODS:

  • Intervention studies that examine the role of the microbiome in mediating the beneficial health effects of botanical dietary supplements.

  • Utilization of "omics" technologies such as metabolomics or proteomics to evaluate biomarkers of total nutrient intake (from diet and dietary supplements) in cohort studies or projects that add novel biomarkers to randomized controlled trials of dietary supplements.

  • Studies that investigate the contrasting effects of dietary supplements in preventing or causing different diseases (e.g. folic acid and its effects on neural tube defects and colon cancer).

  • 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).

  • 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).

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

  • Studies that do not give the supplement by mouth.

  • Studies that administer the supplement 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 metabolic pathways.

  • Human, animal, or laboratory studies that correlate physiological levels of dietary supplement ingredients, 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-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, 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, such as a study investigating the use of tyrosine to treat phenylketonuria. However, if the research is focused on identifying 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.

II. Key Dates

  July 17, 2018   Letter of intent submitted to Dr. Cindy Davis at davisci@mail.nih.gov      
  July 24, 2018   Notification by ODS of whether or not the applicant is encouraged to submit a full proposal      
  August 22, 2018   Full applications submitted to Dr. Cindy Davis at davisci@mail.nih.gov     
  September 19, 2018     Proposal review by ODS
  September 26, 2018   Notification of ODS funding decision
  Fall 2019   Participation in ODS Scholars Symposium if applicant is funded

III. Requirements for Application Submission

A. General Guidelines

  1. Support is available for NEW projects, including pilot or feasibility studies; collection of preliminary data; secondary data analysis of existing data; small, self-contained research projects, and development of new research technologies. ODS co-funding is intended to stimulate new avenues of research within the NIH. Collaborative studies between different NIH institutes or different laboratories is encouraged.

  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 will be for FY2019. They may 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. Submitted project applications should be within the Guidelines for the Conduct of Researchexternal link disclaimer.

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

  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 ODS should be included in the application (see ODS Strategic Plan Goals).

  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 Policy for Natural Products Integrity of the National Center for Complementary and Integrative Health (NCCIH) will be required prior to funding. (An ODS summary of the policy is provided for your reference. See attached Minimum Criteria: Assessment of Dietary Supplement Ingredient Integrity.) Additional requirements for characterizing dietary supplements and/or their ingredients for clinical trials, animal studies, and the special case of probiotics can be found at http://nccih.nih.gov/research/policies/naturalproduct.htm.external link disclaimer

  11. For studies that measure 25-hydroxyvitamin D [25(OH)D], the PI will be required to use National Institute of Standards and Technology (NIST) standard reference materials and are encouraged to participate in the NIST Vitamin D Metabolites Quality Assurance Program.external link disclaimer For large clinical trials, the laboratory making the measurement should participate in the Center for Disease Control and Prevention (CDC) Vitamin D Certification Program.external 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 July 17, 2018)

This letter is limited to a one-page description of the project and its relevance to the ODS mission. Also include a letter from your Scientific Director indicating approval to submit.

C. Submission of Materials (Must be received by 5:00 pm on August 22, 2018):

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. Address the scientific premise of the proposed research, including a discussion of the strengths and weaknesses of prior research crucial to support the application.

  • Clearly defined specific aims. Identify preliminary studies if available.

  • Experimental design and methods. Describe what you propose and how your design and methods 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 and 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 (both the dietary supplement and any experimental diets)

    • Relevant biological variables, such as sex

2. Supporting documents, in addition to the 10-page Research Plan, should include:

  • Abstract

  • Budget

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

  • Training Plan for applicants who are not Principal Investigators. It is not to exceed two pages, excluding publications. The candidate and the mentor are jointly responsible for preparing the training plan. It 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 in developing a program of study or to monitor the candidate’s progress through the training. The training plan should include:
    1. A statement of the candidate’s objectives and long-term career goals.

    2. A description of the candidate's prior training and how it relates to his/her objectives and long-term career plans.

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

    4. A description of the candidate’s research efforts to date, including any 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 they 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. 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 utilized to promote the candidate’s independence.
  • Appropriate product integrity informationexternal link disclaimer 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 the 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.

IV. Expectations of Funded Scholars

A. Present his/her research findings at the ODS Scholars Symposium which will occur in the fall of 2019 (date to be determined);

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

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

D. Provide a final report within six months of project completion;

E. Participate in the Dietary Supplement Scientific Interest Groupexternal link disclaimer;

F. Participate in the ODS Mary Frances Picciano Dietary Supplement Research Practicum.

Direct inquiries and submit requests to Cindy Davis at davisci@od.nih.gov or call her at 301-496-0168.

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 remain 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

2017 Funded ODS Scholars

IC: NCI
Scholar: Erikka Loftfield
Mentor: Neal Freedman
Title: Multivitamin use and mortality: leveraging repeat measures and metabolomic profiles to clarify the impact of multivitamin use and mortality risk

IC: NHLBI
Scholar: Alexander Sorokin
Mentor: Nehal Mehta
Title: The effect of long-chain omega-3 polyunsaturated fatty acids supplementation on inflammatory response and lipoprotein metabolism

IC: NHLBI
Scholar: Haiming Cao
Title: Functional Analysis of human long non-coding RNAs regulated by dietary supplementation of omega-3 or omega-7 fatty acids using a humanized mouse model

IC: NIAID
Scholar: Nicholas Collins
Mentor: Yasmine Belkaid
Title: Enhancing and restoring immunological memory by dietary supplementation with oleic acid

IC: NIAID
Scholar: Jingwen Jiang
Mentors: Eric Long and Synatu Rajagopalan
Title: The effect of dietary zinc supplementation on the function of cytotoxic lymphocytes in healthy adults

IC: NIDDK
Scholar: Maren Podszun
Mentor: Yaron Rotman
Title: Vitamin E as a modulator of hepatic lipid metabolism

IC: NIEHS
Scholar: Tong-Moon "Mark" Park
Mentors: Dale Sandler and Clarice Weinberg
Title: The influence of ß-carotene supplements, dietary and circulating carotenoids on oxidative stress, inflammation, and risk of postmenopausal breast cancer in the Sister Study

2016 Funded ODS Scholars

IC:  NCI
Scholar:  Chad Brocker
Mentor:  Frank Gonzalez
Title:  The role of peroxisome proliferator-activated receptor alpha in obesity-induced vitamin D deficiency

IC:  NCI
Scholar:  Majda Haznadar
Mentor:  Curtiss Harris
Title:  CYP24A1 and mut-p53 pro-tumorigenic effects in lung cancer through vitamin D signaling

IC:  NIAAA
Scholar:  Miriam Boscarsly
Mentor:  Dave Lovinger
Title:  Striatal dopamine circuitry in mediating caffeine-induced consummatory behavior

IC: NIAAA
Scholar:  Youngshim Choi
Mentor:  Byoung-Joon Song
Title:  The protective effect of dietary indole-3-carbinol supplementation on chronic alchol-induced liver injury via modulating the adipose tissue-liver signaling axis

IC:  NIAAA
Scholar:  Ozge Gunduz Cinar
Mentor:  Andrew Holmes
Title:  Role of oleic acid in anxiety disorders for cotnrol of learned inhibition of fear

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