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Career and Professional Development

Clinical and Translational Nutrition

Session Type: Learning Lab

Designing and Conducting Human Nutrition RCTs

Tuesday, July 12, 2022

12:00 PM – 5:00 PM ET

Speaker(s)

Cheryl Anderson, MPH, PhD

University of California, San Diego
La Jolla, California, United States

Disclosure information not submitted.
LA

Lawrence Appel, MD, MPH

Professor
Johns Hopkins University School of Medicine, Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research
Baltimore, Maryland, United States

Disclosure(s): No relevant financial relationship(s) with ineligible companies to disclose.
Martha Belury, PhD, RD, Ph.D, RD

Carol S. Kennedy Professor of Nutrition
Human Sciences
The Ohio State University
Columbus, Ohio, United States

Disclosure(s): No relevant financial relationship(s) with ineligible companies to disclose.
JL

Johanna Lampe, PhD, RD

Professor
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States

Disclosure(s): No relevant financial relationship(s) with ineligible companies to disclose.
AL

Alice Lichtenstein, DSc (she/her/hers)

Gershoff Professor of Nutrition Science and Policy Director, Cardiovascular Nutrition Laboratory and Senior Scientist
Cardiovascular Nutrition Laboratory
JM USDA Human Nutrition Research Center on Aging, Tufts University
Boston, Massachusetts, United States

Disclosure(s): No relevant financial relationship(s) with ineligible companies to disclose.
DL

DeAnn Liska, PhD

Texas A&M AgriLife

Disclosure information not submitted.
Rick Mattes, MPH, PhD, R.D.

Distinguished Professor of Nutrition Science
Purdue University
West Lafayette, Indiana, United States

Disclosure(s): Almond Board of California: Grant/Research Support (Ongoing)
Grain Food Foundation: Advisory Committee/Board Member (Ongoing)
Mars Wrigley: Advisory Committee/Board Member (Ongoing)
SS

Sue Shapses, PhD

Rutgers University
New Brunswick, New Jersey, United States

Disclosure(s): No relevant financial relationship(s) with ineligible companies to disclose.
LS

Linda Snetselaar, PhD, RD

University of Iowa
Iowa City, Iowa, United States

Disclosure information not submitted.
Connie Weaver, PhD (she/her/hers)

Distinguished Professor of Research
San Diego State University
San Diego, California, United States

Disclosure(s): No relevant financial relationship(s) with ineligible companies to disclose.

Disclosure(s):

Lawrence J. Appel, MD, MPH: No relevant financial relationship(s) with ineligible companies to disclose.

Martha A. Belury, PhD, RDN: No relevant financial relationship(s) with ineligible companies to disclose.

Johanna W. Lampe, PhD: No relevant financial relationship(s) with ineligible companies to disclose.

Alice H. Lichtenstein, DSc: No relevant financial relationship(s) with ineligible companies to disclose.

Richard Mattes, MPH, PhD, R.D.: Almond Board of California: Grant/Research Support (Ongoing)
Grain Food Foundation: Advisory Committee/Board Member (Ongoing)
Mars Wrigley: Advisory Committee/Board Member (Ongoing)

Sue A. Shapses, PhD: No relevant financial relationship(s) with ineligible companies to disclose.

Connie M. Weaver, PhD: No relevant financial relationship(s) with ineligible companies to disclose.

Overview
Human nutrition randomized controlled trials (RCTs) have unique considerations and conducting them with the highest scientific rigor is essential to the development of evidence-based dietary guidance for promoting optimal health and advancing health care. Diet-related interventions can include diet and/or behavioral manipulation, provision of foods or entire meals, or delivery of dietary components in individual food items or supplements.

Join an esteemed faculty for a training on the design and conduct of human nutrition RCTs, documentation and reporting of all aspects of clinical trial management, and data analysis and reporting of results. Course content is based on a series of articles published in Advances in Nutrition; see reading assignments below.

Target Audience

Faculty in graduate nutrition/obesity and related programs
NIH-funded Nutrition Obesity Research Center members
Graduate students and early career professionals
Contract research organizations staff
International nutrition societies members
Industry scientists
Funding agencies personnel
Clinical research oversight committee members and auditors

Course Format
The course will be conducted virtually and consists of plenary sessions with lectures and panel discussions. Programming will end each day with an interactive breakout session where practical aspects can be reviewed and discussed in smaller group forums.

A certificate of attendance will be provided at the conclusion of the training. Presentations and course resources will be archived for on-demand viewing.

Reading Assignments as Preparation for Course Attendance

Learning Objectives:

Use core principles to design and conduct controlled feeding studies
Prepare documentation and reporting requirements for clinical trial management

Presentations:

12:00 PM – 12:10 PM ET

Welcome and Introductions (Designing and Conducting Human Nutrition RCTs)
Speaker: Martha A. Belury, PhD, RD, Ph.D, RD – The Ohio State University
Speaker: Connie M. Weaver, PhD (she/her/hers) – San Diego State University
12:10 PM – 12:15 PM ET

Session 1: Designing and Conducting Human Nutrition RCTs (Designing and Conducting Human Nutrition RCTs)
Speaker: Cheryl Anderson, MPH, PhD – University of California, San Diego
12:15 PM – 12:30 PM ET

Design and Conduct of a Randomized, Crossover, Controlled Feeding Study: Example from the Soy vs Animal Protein Study +/- Soy Derived Isoflavones (Designing and Conducting Human Nutrition RCTs)
Speaker: Alice H. Lichtenstein, DSc (she/her/hers) – JM USDA Human Nutrition Research Center on Aging, Tufts University
12:30 PM – 12:50 PM ET

Design and Conduct of a Randomized, Crossover, Controlled Feeding Study: Example from the Carbohydrates and Related Biomarkers (CARB) Study (Designing and Conducting Human Nutrition RCTs)
Speaker: Johanna W. Lampe, PhD, RD – Fred Hutchinson Cancer Research Center
12:50 PM – 1:15 PM ET

Translation of Findings from the DASH Feeding Study: Design and Conduct of PREMIER, a Behavioral Intervention Trial (Designing and Conducting Human Nutrition RCTs)
Speaker: Lawrence J. Appel, MD, MPH – Johns Hopkins University School of Medicine, Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research
1:15 PM – 1:35 PM ET

Session 1 Panel Discussion (Designing and Conducting Human Nutrition RCTs)
Speaker: Lawrence J. Appel, MD, MPH – Johns Hopkins University School of Medicine, Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research
Speaker: Johanna W. Lampe, PhD, RD – Fred Hutchinson Cancer Research Center
Speaker: Alice H. Lichtenstein, DSc (she/her/hers) – JM USDA Human Nutrition Research Center on Aging, Tufts University
Speaker: Connie M. Weaver, PhD (she/her/hers) – San Diego State University
1:50 PM – 2:05 PM ET

Session 2: Documentation and Regulation for Human Nutrition RCTs / Importance of Documentation (Designing and Conducting Human Nutrition RCTs)
Speaker: Connie M. Weaver, PhD (she/her/hers) – San Diego State University
2:05 PM – 2:20 PM ET

Documentation of Dietary Interventions in a Controlled Feeding Study and a Tolerance Study (Designing and Conducting Human Nutrition RCTs)
Speaker: DeAnn Liska, PhD – Texas A&M AgriLife
2:20 PM – 2:35 PM ET

Regulatory OVERSIGHT in Clinical Trials: WHI & WHIMS (Designing and Conducting Human Nutrition RCTs)
Speaker: Linda G. Snetselaar, PhD, RD – University of Iowa
2:35 PM – 2:50 PM ET

Development of SOPs and Staff Training in Clinical Trials: OWLE (Designing and Conducting Human Nutrition RCTs)
Speaker: Sue A. Shapses, PhD – Rutgers University
2:50 PM – 3:15 PM ET

Session 2 Panel Discussion (Designing and Conducting Human Nutrition RCTs)
Speaker: DeAnn Liska, PhD – Texas A&M AgriLife
Speaker: Rick Mattes, MPH, PhD, R.D. – Purdue University
Speaker: Sue A. Shapses, PhD – Rutgers University
Speaker: Linda G. Snetselaar, PhD, RD – University of Iowa
3:15 PM – 3:20 PM ET

Highlights (Designing and Conducting Human Nutrition RCTs)
Speaker: Cheryl Anderson, MPH, PhD – University of California, San Diego