Key Dates

Related Announcements

• February 6, 2024 - Natural Product Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24 Clinical Trial Required). See NOFO PAR-24-125.
• February 2, 2024 - Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 Clinical Trial Required). See NOFO PAR-24-123.
• February 1, 2024 - NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required). See NOFO PAR-24-115.
• February 1, 2024 - NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required). See NOFO PAR-24-116.
• February 1, 2024 - NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required). See NOFO PAR-24-124.                                                                                                                                                                                                                                                                                                                                                                                                                  
  
   

Issued by

National Center for Complementary and Integrative Health (NCCIH)

Purpose

Purpose

In accordance with our mission, the National Center for Complementary and Integrative Health (NCCIH) is issuing this notice to inform the extramural research community that NCCIH will expand the priorities for natural product clinical trials in the notice of funding opportunities (NOFOs) noted above. The additional priorities include the following: studies that examine the effects of natural products across the continuum of background dietary intake, and studies that evaluate whether nutritional status moderates target engagement or clinical outcomes. This notice informs the extramural research community that NCCIH will deprioritize applications that do not address dietary intake and nutritional status when appropriate. This deprioritization will apply to investigator-initiated research applications.

Background

NCCIH is committed to the rigorous investigation of promising complementary and integrative health approaches with nutritional therapeutic inputs (often called natural products). Promising natural products (i.e., botanicals, probiotics, and products marketed as dietary supplements) have compelling preclinical or preliminary clinical evidence for potential health benefit. Natural products include promising nutritional regimens that standardize the amount of a specific naturally occurring nutritional compound (e.g., omega-3 fatty acids, anthocyanidins, or polyphenols) and have compelling preliminary evidence suggesting potential benefit in treating a condition, disorder, or disease.

Nutritional intervention research in humans is complicated by the complex and varied background nutritional status and dietary intake of participants in clinical trials. To enhance rigor, reproducibility and generalizability, it is important that trials of natural products that are part of the regular or occasional dietary intake include rigorous methods to account for the  dietary intake and heterogeneity across participants (e.g., assessment of nutritional status; collection of data about dietary intake at baseline and throughout the trial; collection of data about factors that may impact absorption or metabolism of the natural product; rigorous study design  to ensure balance across study arms with strategies such as stratified randomization; or rigorous statistical methods to examine treatment heterogeneity through pre-specified subgroup analyses or analyses of effect modification by background nutritional status or other participant characteristics on target engagement or clinical outcomes).

NCCIH Priorities for Developing and Pilot Testing Natural Products 
As NCCIH’s clinical research portfolio matures, NCCIH has identified targeted areas of investigation to align with the NCCIH Strategic Plan (https://www.nccih.nih.gov/about/strategic-plans-and-reports). Focus is on management of conditions for which natural products are used by the public and where there is evidence of a postulated mechanism of action. For the suite of natural product clinical trial NOFOs, NCCIH is adding the following high-priority topic areas :

• Trials that examine the effects of natural products across the continuum of background dietary intake
• Trials that evaluate whether nutritional status moderates target engagement or clinical outcomes

Applicants are strongly encouraged to consult with NCCIH program officials prior to submission. NCCIH will deprioritize applications that do not address background dietary intake and nutritional status when appropriate.

This notice applies to applications submitted on or after October 1, 2024.

Inquiries

Please direct all inquiries to:

Sekai Chideya, M.D., M.P.H.
National Center for Complementary and Integrative Health (NCCIH)
Email: sekai.chideya@nih.gov