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Workshop: Methods and Measurement in Trials of 5-year Caloric Restriction and Time-restricted Eating Interventions

Dates

October 10, 2023 | 10:30 a.m. to 5:00 p.m. ET

October 11, 2023 | 9:45 a.m. to 5:30 p.m. ET

Audience

Scientists, health care professionals, academia, and industry.

Location

This workshop was held over Zoom. 

Purpose and Background

The Division of Geriatrics and Clinical Gerontology at the National Institute on Aging was pleased to have sponsored the virtual workshop “Methods and Measurement in Trials of 5-year Caloric Restriction and Time-restricted Eating Interventions” on October 10-11, 2023. We explored the state of the science, as well as the opportunities and challenges, in areas such as:

Methodologic Considerations for Selection and Measurement of Outcomes:

  • How to handle multiple outcomes (scales, composite, dimensionality reduction methods, etc.)
  • Considerations about differing types of tissues validity (e.g., construct, predictive) for differing outcomes.
  • Relationships of measurement properties of potential outcomes to selection and timing of outcome measures.

Generic issues:

  • Timing of measurements (temporal relationships of differing measures, and optimal timing in young and old populations).
  • Specific circadian outcome variables – hormones, metabolic rates.
  • Additional imaging studies.

Expectations for the talks and data discussion:

  • Talks/data discussed should not be limited to CALERIE findings/ancillary studies.
  • Measures in animal studies should be discussed in relation to how/when they can be measured in humans, e.g., many changes are not conserved across tissues.
  • Statistical talks should be focused on how to use modeling/existing data and pilot results to inform the outcomes’ selection and sample size determination.
  • There should be discussions of the expected similarities and differences in the effects of CR and TRE on outcomes – We are planning two parallel interventions.
  • Need expertise in the measurement of mechanisms in humans.

Agenda

Note: This agenda is in Eastern Daylight Time.

Day 1: Tuesday, October 10

10:30 – 11:00 a.m. Introduction and Presentation of Workshop Goals

11:00 – 12:20 p.m. Risk Factors and Progression of Pre-morbid Pathophysiology in a Young Healthy Population

  • Cardiometabolic, including insulin sensitivity, William Kraus, Duke Univ.
  • Cancer, Justin Brown, Pennington Biomedical Research Center
  • Bones and Movement, Clifford Rosen, Jackson Lab, ME
  • Arterial Imaging and Progression of Atherosclerosis, Howard Hodis, Univ. of Southern California
  • Q&A and Discussion

12:20 – 12:30 p.m. Break

12:30 – 1:30 p.m. Clinical Outcome Measures in an Older Population

  • Multimorbidity measures in an older population, Walter Rocca, Mayo Clinic Rochester, MN
  • Functional outcomes, Peggy Cawthon, California Pacific Medical Center
  • Predictors of subsequent survival, Anne Newman, Univ. of Pittsburgh
  • Q&A and Discussion

1:30 – 2:15 p.m. Lunch Break

2:15 – 3:00 p.m. Measures of Neurologic and Cognitive Functions in Both Age Ranges

  • Neurologic effects, Joe Verghese and Jeannette Mahoney, Albert Einstein CM
  • Effect of dietary interventions on cognitive, behavioral, and psychological outcomes, Corby Martin, Pennington Biomedical Research Center
  • Q&A and Discussion

3:00 – 4:00 p.m. Measures of Circadian Rhythms, Sleep, and Physical Activity in Both Age Ranges

  • Specific circadian outcome variables, Satchidananda Panda, Salk Institute
  • Effects on Sleep, Frank Scheer, Harvard Univ.
  • Effects on Physical Activity, Jason Fanning, Wake Forest Univ.
  • Q&A and Discussion

4:00 – 4:15 p.m. Break

4:15 – 5:00 p.m. Endocrine Effects and their Consequences:

  • Thyroid axis, Anne Cappola, UPenn
  • Q&A and the Day 1 Discussion

5:00 pm Adjourn for the day

Day 2: Wednesday, October 11

9:45 – 9:50 a.m. Welcome to Day 2

9:50 – 11:15 a.m. Implications of Studies in Nonhuman Models for Measures that Might Be Made in Human Trials

  • Harnessing CR-mimetics from CALERIE, Vishwa Deep Dixit, Yale
  • Rodent CR, John Speakman, Univ. of Aberdeen
  • Primate CR, Rozalyn Anderson, Univ. Wisconsin
  • Rodent TRE, Satchidananda Panda, Salk Institute
  • Q&A and Discussion

11:15 – 11:30 a.m. Break

11:30 – 1:15 p.m. Effects on Mechanisms Proposed to Influence Age-Related Changes and Effects of Predictors of Age-related Outcomes

  • Autophagy, Ana Maria Cuervo, Albert Einstein CM
  • Clonal hematopoiesis, Alexander Bick, Vanderbilt Univ.
  • Phenotypic and epigenetic predictors of age-related outcomes, Daniel Belsky, Columbia Univ.
  • Mitochondrial function, Bret Goodpaster, Advent Health, Orlando
  • Q&A and Discussion

1:15 – 2:00 p.m. Lunch Break

2:00 – 3:00 p.m. Metabolic Effects and their Cellular and Physiologic Basis, Part I

  • Effects on microbiome, Nathan Price, Thorne HealthTech, New York
  • Adipose tissue biology, Samuel Klein, Washington Univ.
  • Assessments of systemic mitochondrial bioenergetic capacity, Anthony Molina, UCSD
  • Q&A and Discussion

3:00 – 3:15 p.m. Break

3:15 – 4:00 p.m. Metabolic Effects and their Cellular and Physiologic Basis, Part II

  • RMR, TDEE, Activity-related energy expenditure Herman Pontzer, Duke Univ.
  • Body composition effects – including liver adiposity, size, structure, cell size (imaging techniques), Steve Heymsfield, Pennington Biomedical Research Center
  • Q&A and Discussion

4:00 – 4:15 p.m. Break

4:15 – 5:30 p.m. Design Issues for Full-Scale Trial

  • Design, analysis, and sample sizes issues for group-based intervention trials, David Murray, NIH
  • Types of specimens to collect and in vivo tests to conduct, Jamie Justice, XPRIZE Foundation and Wake Forest University
  • CALERIETM data set and biospecimen repository, Kim Huffman, Duke Univ.
  • Q&A and Final Discussion

5:30 p.m. Adjourn for the day

Contact Information

For more information about this workshop, please contact Irina Sazonova, Ph.D. at irina.sazonova@nih.gov.

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