A written application is required and must include the information described below. Applications may be prepared using Microsoft Word (or other word processor) but must be saved as a single pdf file. While there is no maximum number of pages for the entire file, the Research Plan section should not exceed 6 pages, including text, tables, graphs, and figures.
Guidelines for Proposal
- Scholar candidates must be full-time appointees at an NIH intramural laboratory at the time of proposal submission.
- Scholar candidates are required to commit a minimum of 9 months of effort (i.e., 75% of full-time effort) to their research project. Candidates may engage in other duties as part of the effort not covered by this award, if such duties do not interfere with or detract from the proposed research program.
- The proposal should be written by the scholar candidate but reviewed by the mentor before submission to ODS.
- Research projects should be conducted in accordance with the NIH Intramural Research Program guidelines.
- For clinical studies investigating dietary supplements and/or supplement ingredients, the supplement should be administered in physiologically relevant forms and concentrations and must be administered orally.
- For basic research, the ultimate intended outcome should be to develop and provide oral supplementation. Projects without a clear emphasis on oral ingestion will be screened out.
- In studies employing dietary assessments or surveys, questions about dietary supplement use must be included, and the survey instruments should be validated.
- A rationale for how the proposed research fits within the mission of ODS should be included in the cover letter or executive summary in the proposal (See ODS Strategic Plan for 2025–2029).
- Investigators conducting clinical studies must contact the Center for Drug Evaluation and Research at FDA to determine whether an Investigational New Drug (IND) application is required.
- Reproducible research on dietary supplements and related natural products requires the use of replicable, well-characterized interventions (test articles). Investigators must demonstrate that their investigative team has appropriately tested and evaluated the reproducibility of their dietary supplement or natural product test articles' identity, purity, strength, composition, and stability.
- Specific requirements to support demonstration of test article integrity
- Identity
- Demonstrate the test articles' chemical and/or taxonomic identity. For example, determination of vitamin D2 versus D3, folate versus folic acid, Panax ginseng versus Panax quinquefolius, or probiotic bacterial species.
- Non-specific characteristics for the analysis of purified chemicals, such as color or particle size, are unacceptable for demonstrating identity.
- For isolated chemical compounds, provide standardized chemical name(s) (e.g., IUPAC or InChi) and common name(s).
- For complex test articles derived from living organisms such as botanicals, provide the complete taxonomic/scientific name along with the common name and source of the plant/animal material/extract/phytochemical.
- For probiotics, identify the test article for each genus, species, and strain. Methods of strain identification must assure absence of pathogenic variants, undesirable metabolites, and toxicity.
- Purity
- Quantify test article chemical purity. For example, quantification of >99% pure epigallocatechin gallate by high-performance liquid chromatography, along with an assessment of what comprises the 1% impurity(ies).
- Demonstrate isomeric purity or ratios where appropriate. For example, determination of α-, β-, γ-, and δ-tocopherol isomers in a vitamin E preparation.
- For fatty acid test articles, such as preparations of omega-3 polyunsaturated fatty acids, quantify any lipid oxidation.
- Strength
- Demonstrate quantitative verification of the amounts of active or investigational substances provided by the test article. For example, specify and quantify the milligrams of calcium per tablet or grams of curcumin per kilogram of turmeric rhizome.
- For probiotics, describe the measure of bioactivity (e.g., colony forming units or viable cell counts) and demonstrate that specification is replicable in the vehicle matrix.
- Composition
- Specify and verify the constituent(s), if any, to which the test article is standardized. For example, a Ginkgo biloba preparation that meets U.S. Pharmacopeia specifications of 22–27% flavonol glycosides.
- Demonstrate the reproducibility of the test article's characteristics.
- Where applicable, describe manufacturing processes that influence the test articles' chemical profile composition. For example, an ethanol versus an aqueous extract of ginger rhizome phytochemicals.
- Demonstrate the composition of multi-component, complex preparations. For example, experimental and control animal diet formulations or withanolide and withanoside chemical profiles for an ashwagandha preparation. Complementing analyses of anticipated constituents with untargeted analyses is preferable wherever feasible but is not required at the time of application.
- For placebos and control materials used in clinical research — in addition to specifying and demonstrating identity, purity, and composition, verify that it matches the test article(s) on sensory characteristics, that the sensory characteristics are stable, and that it does not contain bioactive components that may confound the research data (e.g., a soy-based ingredient in a placebo used in a study of isoflavone health effects).
- Stability
- Demonstrate the stability of dietary ingredients in the matrix that will be used in the study (e.g., animal chow, cell culture media, capsules, tablets, etc.) for at least the duration of the study.
- Describe how the test articles will be monitored for stability throughout the study period, and plans for replacing test materials if degradation beyond the product specifications is detected.
- Safety Considerations
- Demonstrate that test articles are free of potentially harmful or deleterious contaminants/impurities (whether accidental or deliberate), e.g., pesticides, drugs, toxins, microbes, or toxic elements/heavy metals.
- For probiotics, show that the chosen strain(s) is(are) sensitive to clinically relevant antibiotics.
- Analytic methods must be adequately described and should be demonstrated to be scientifically valid (accurate and precise) and suitable for their intended purpose.
- For studies that measure vitamin D metabolites in biological samples, the investigator is expected to use appropriate reference materials (e.g., National Institute of Standards and Technology (NIST) standard reference materials SRM 972a
) to assure clinical data integrity.
- Additional background information and resources for natural product characterization can be found in the ODS webpage The Importance of Natural Product Characterization and Integrity for Dietary Supplement Research.
Action: Provide a research proposal with the following information.
- Cover letter
- The cover letter should include a statement of support from the candidate's mentor (or candidate's PI, if different from the mentor).
- The cover letter should contain the signatures of the:
- Scholar candidate
- Mentor (or candidate's PI, if different from the mentor)
- Division or branch chief
- IC scientific director or IC director
- Executive Summary/Abstract
- Biosketches
- Include biosketches for the scholar candidate, mentor (or candidate's PI, if different from the mentor), and co-mentors (if applicable)
- Budget
- Research Plan (maximum 6 pages)
- Specific Aims
- Background and Significance
- Preliminary Studies (if applicable)
- Experimental Approach
- Study design
- Methods
- Outcomes
- Statistical Analysis Plan
- Randomization details (if applicable)
- Subject inclusion and exclusion criteria (if applicable)
- The chemical/biological composition and standardization of the intervention (both the dietary supplement and any experimental diets)
- Product Integrity
- Appropriate product integrity: authentication of key biological and chemical resources and natural product integrity
- Training Plan for Scholar Candidate
- 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 be signed by the mentor and the candidate.
- Training plan timeline
- The training plan should include:
- A description of the candidate's professional responsibilities in their current NIH research position
- A statement of the candidate's objectives and long-term career goals
- A description of the candidate's prior training and research efforts to date, including any publications, previous research interests, and experience
- A description of the mentor's role in the training plan and how expectations, deliverables, and oversight of the trainee will occur
- A description of any other mentors and their role(s) in the candidate's training plan
- A description of the research and educational resources of the institution and laboratory that will promote the candidate's research independence
- References
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