Frequently Asked Questions About the ITP
What is the purpose of the NIA Interventions Testing Program (ITP)?
Answer: The ITP tests diets, drugs, or other inventions to see if they prevent disease and extend lifespan in mice.
Can I suggest an intervention for inclusion in this test program?
Answer: Yes—a key goal of the ITP is to test the effects of diets, drugs, nutritional supplements, or other interventions that are proposed by interested collaborators. Intervention proposals can be submitted by scientists who work in academic laboratories or in government or commercial research institutes.
What classes of interventions are suitable for this program?
Answer: Proposed interventions can be pharmaceuticals, nutraceuticals, foods, diets, dietary supplements, plant extracts, hormones, peptides, amino acids, chelators, redox agents, or other agents or mixtures of agents. Priority consideration will be given to the interventions that are easily obtainable, reasonably priced, and can be delivered in the diet or water.
Where are these experiments conducted?
Answer: The experiments are conducted in three research laboratories: one at the Jackson Laboratories, one at the University of Michigan, and one at the University of Texas Health Sciences Center at San Antonio.
How are the experiments conducted?
Answer: Agents are administered, usually in the food or water, to groups of specific pathogen-free male and female mice of the UM-HET3 stock. UM-HET3 mice are the progeny of CB6F1 females and C3D2F1 males and are genetically heterogeneous, the equivalent of a large sibship. Each mouse is observed until its natural death or until it becomes so severely ill that survival for more than an additional week seems very unlikely. The design includes sufficient numbers of mice (80 in each treatment group and 170 in the control group) to provide 80 percent power to detect a 10 percent increase in average lifespan.
Each mouse also is evaluated for a small set of age-sensitive traits, such as changes in the immune system, spontaneous activity, and lens turbidity. Mice not enrolled in the longevity study are exposed to each intervention to permit assessment of blood and tissue levels of the agents and to help determine if each agent is having its expected metabolic or physiological effect.
How do I propose a specific intervention?
Answer: Individuals who wish to suggest ("sponsor") an intervention are asked to provide a rationale as to why they believe the intervention will delay aging or reduce the risk of late-life disease. The rationale may include previous experimental data on mice, cells, people, or other animals that are relevant to the proposal.
The sponsor of the intervention also is asked to: (1) propose a specific dose and route of administration, (2) describe any information about possible toxic side effects and safety issues, (3) discuss methods for detecting the agent in the treated mice, and (4) document its expected physiological effects.
Can I propose more than one intervention?
Answer: Yes—there is no limit to the number of interventions any individual can propose. Each intervention will be considered separately on its own merits.
Can I propose that an agent be tried at two or more doses, or do I have to select a single dose to test?
Answer: Because the ITP can accept only four or five new interventions for study each year, a decision to test two doses of a given agent would diminish the number of other interventions that can be evaluated. Therefore, most agents will be tested at only a single dose. If there are good reasons for considering two or more doses, these should be described carefully in the sponsor's application.
Who selects which interventions to be tested each year?
Answer: The ITP has an Access Committee that evaluates each application and discusses possible changes and improvements with the sponsor of the proposed intervention. The Access Committee selects approximately five proposals each year for final approval by the ITP Steering Committee.
How does this process differ from the usual NIH peer review?
Answer: The ITP selection process does not resemble the usual NIH peer review process. The ITP does not use an NIH grant application form, and the application does not go through the peer review system. Sponsors of specific interventions are treated as collaborators on the ITP project. In particular, the Access Committee and the leaders of the ITP work with each applicant to develop the best protocols for incorporation into the program.
Prior to making a recommendation that the intervention be accepted or rejected, Access Committee members typically correspond with sponsors of each intervention to: (1) request additional information, (2) suggest modifications of the protocol, and (3) consult about the design of the experiments to be conducted.
What do I get out of this?
Answer: Sponsors of interventions accepted for the ITP will work with the ITP investigators to develop the test protocol for their compound. All data will be available for sponsors' use in their own grant applications, research talks, etc., free of charge. Sponsors will be asked to serve as coauthors on any papers that result from research using their intervention proposal and will help to interpret and report the data.
If the agent shortens the lifespan or has negative effects, what will happen to the data?
Answer: The ITP plans to publish all data, including data on agents that fail to increase lifespan, delay late-life illnesses, or interventions that have deleterious side effects.
Do I get paid for my efforts in this collaboration?
Answer: No—sponsors are not paid for their efforts as collaborators in the ITP, either as consultants or by means of research grant awards.
Are funds available to support work conducted in my laboratory in connection with the ITP?
Answer: Funds can be provided to pay for specific services. For example, if a laboratory produces a compound that will be tested by the ITP, reimbursement for developing the agent will be made. The ITP may need assistance in measuring the blood or tissue levels of an administered agent or for measuring its physiological effects (e.g., changes in gene expression, effects on anti-inflammatory responses, or somatic mutation rates), and in these cases, the ITP would expect to pay for the costs of these assays as performed in the laboratory.
If I propose that an agent or diet be tested in the ITP, does this prevent me from using this agent in a grant application or other sponsored project of my own?
Answer: No—sponsors of interventions may inquire about other sources of funding, including NIH grant funds for studies of the same intervention. Agents accepted by the ITP are evaluated for effects on longevity and a small battery of age-sensitive traits, but our resources do not allow us the biochemical or physiological impact of the intervention in much detail.
For example, an evaluation of a specific anti-inflammatory agent in the ITP would not conflict with—and might even be seen as supplementing—an individual R01 application to evaluate the effect of the agent on somatic mutations, lipid profiles, gene expression levels, immune status, or disease resistance, or the effects on specific cell types, mouse stocks, or other questions of interest.
Is there a deadline for submission of a proposed intervention?
Answer: See the application page for the next deadline
Where can I receive more information about the ITP?
Answer: The ITP is coordinated by NIA and its Biology of Aging Program. For more information, contact:
Dr. Francesca Macchiarini
National Institute on Aging
National Institutes of Health
7201 Wisconsin Avenue, GW 3C300
Bethesda, MD 20892