Best Practices for Human RCTs Collection

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.

This collection includes two separate courses titled:

  • Designing and Conducting Human Nutrition RCTs
  • Laboratory Management and Statistical Analysis Plans for Clinical Nutrition Studies

Reading Assignments as Preparation for Course Attendance

 

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Learning Objectives

​​​​​​Designing and Conducting Human Nutrition RCTs
  • Use core principles to design and conduct controlled feeding studies
  • Prepare documentation and reporting requirements for clinical trial management
Laboratory Management and Statistical Analysis Plans for Clinical Nutrition Studies
  • Describe how to develop a data analysis plan
  • Explain best practices for laboratory management
  • Use core principles to complete a statistical analysis and report results

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 summary
Available credit: 
  • 6.50 Attendance

    Learners are eligible to download a Certificate of Attendance upon activity completion. A Certificate of Attendance confirms the learner has completed the activity and does not confer any continuing education credit to the learner from ASN.

Course opens: 
04/01/2024
Course expires: 
03/31/2026
Cost:
$60.00
Rating: 
0

This collection includes the following courses:

Designing and Conducting Human Nutrition RCTs

Welcome and Introductions 

Martha A. Belury, PhD, RDN – The Ohio State University
Connie M. Weaver, PhD – San Diego State University

Session 1: Designing and Conducting Human Nutrition RCTs 

Cheryl Anderson, MPH, PhD – University of California, San Diego

Design and Conduct of a Randomized, Crossover, Controlled Feeding Study: Example from the Soy vs Animal Protein Study +/- Soy Derived Isoflavones

Alice H. Lichtenstein, DSc – Jean Mayer USDA HNRCA at Tufts University

Design and Conduct of a Randomized, Crossover, Controlled Feeding Study: Example from the Carbohydrates and Related Biomarkers (CARB) Study 

Johanna W. Lampe, PhD – Fred Hutchinson Cancer Research Center

Translation of Findings from the DASH Feeding Study: Design and Conduct of PREMIER, a Behavioral Intervention Trial 

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

Session 1 Panel Discussion

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
Johanna W. Lampe, PhD – Fred Hutchinson Cancer Research Center
Alice H. Lichtenstein, DSc – Jean Mayer USDA HNRCA at Tufts University
Connie M. Weaver, PhD – San Diego State University

Session 2: Documentation and Regulation for Human Nutrition RCTs / Importance of Documentation

Connie M. Weaver, PhD – San Diego State University

Documentation of Dietary Interventions in a Controlled Feeding Study and a Tolerance Study

DeAnn Liska, PhD – Texas A&M AgriLife

Regulatory OVERSIGHT in Clinical Trials: WHI & WHIMS

Linda Snetselaar, PhD, RD – University of Iowa

Development of SOPs and Staff Training in Clinical Trials: OWLE

Sue A. Shapses, PhD – Rutgers University

Session 2 Panel Discussion

DeAnn Liska, PhD – Texas A&M AgriLife
Richard Mattes, MPH, PhD, R.D. – Purdue University
Sue A. Shapses, PhD – Rutgers University
Linda Snetselaar, PhD, RD – University of Iowa

Highlights 

Cheryl Anderson, MPH, PhD – University of California, San Diego

Laboratory Management and Statistical Analysis Plans for Clinical Nutrition Studies

Welcome and Introductions

Penny M. Kris-Etherton, PhD, RDN,FAHA, FNLA, FASN, CLS – Pennsylvania State University

Session 1: Laboratory Management and Statistical Analysis Plans for Clinical Nutrition Studies Part 1 / Elements and Purpose of a Statistical Analysis Plan 

Kristina S. Petersen, PhD, APD, FAHA – Texas Tech University

Preparing a Statistical Analysis Plan

George P. McCabe, PhD – Purdue University

Session 1 Panel Discussion

Kathryn Barger, PhD – JM USDA HNRCA at Tufts University
George P. McCabe, PhD – Purdue University
Joshua W. Miller, PhD – Department of Nutritional Sciences, Rutgers University
Connie M. Weaver, PhD – San Diego State University

Laboratory Considerations 

Joshua W. Miller, PhD – Department of Nutritional Sciences, Rutgers University

Completing Statistical Analyses and Reporting Results

Kathryn Barger, PhD – JM USDA HNRCA at Tufts University

Data Management Planning and Execution

Kevin C. Maki, PhD – Midwest Biomedical Research, Addison, IL and Indiana University, Department of Applied Health Science, School of Public Health

Session 2 Panel Discussion

Kathryn Barger, PhD – JM USDA HNRCA at Tufts University
Kevin C. Maki, PhD – Midwest Biomedical Research, Addison, IL and Indiana University, Department of Applied Health Science, School of Public Health
George P. McCabe, PhD – Purdue University
Joshua W. Miller, PhD – Department of Nutritional Sciences, Rutgers University
Connie M. Weaver, PhD – San Diego State University

Highlights 

Kevin C. Maki, PhD – Midwest Biomedical Research, Addison, IL and Indiana University, Department of Applied Health Science, School of Public Health

Disclosure Policy

The American Society for Nutrition supports fair and unbiased participation of individuals in its education activities. Any real or potential conflicts of interest must be identified and managed. All relevant financial relationships with commercial interests that directly impact and/or might conflict with ASN activities must be disclosed, or disclosure that no relevant financial relationships exist must be documented. Other relationships that could cause private interests to conflict with professional interests must also be disclosed. This policy is intended to openly identify any potential conflict so that participants in an education activity are able to form their own judgments about the presentation. In addition, disclosure must be made of presentations on drugs or devices or uses of drugs or devices that have not been approved by the Food and Drug Administration. 

Speakers

Designing and Conducting Human Nutrition RCTs

Cheryl Anderson, MPH, PhD, University of California, San Diego 
No relevant financial relationship(s) with ineligible companies to disclose.

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

Martha Belury, PhD, RDN, The Ohio State University
No relevant financial relationship(s) with ineligible companies to disclose. 

Johanna Lampe, PhD, Fred Hutchinson Cancer Research Center 
No relevant financial relationship(s) with ineligible companies to disclose. 

Alice Lichtenstein, DSc, Jean Mayer USDA HNRCA at Tufts University 
No relevant financial relationship(s) with ineligible companies to disclose. 

DeAnn Liska, PhD, Texas A&M AgriLife 
No relevant financial relationship(s) with ineligible companies to disclose. 

Richard Mattes, MPH, PhD, R.D., Purdue University
Disclosures: Advisory Committee/Board Member: Grain Food Foundation, Mars Wrigley; Grant/Research Support: Almond Board of California 

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

Linda Snetselaar, PhD, RD, University of Iowa
No relevant financial relationship(s) with ineligible companies to disclose. 

Connie Weaver, PhD, San Diego State University 
No relevant financial relationship(s) with ineligible companies to disclose. 

Laboratory Management and Statistical Analysis Plans for Clinical Nutrition Studies

Kathryn Barger, PhD, JM USDA HNRCA at Tufts University 
No relevant financial relationship(s) with ineligible companies to disclose. 

Penny Kris-Etherton, PhD, RDN,FAHA, FNLA, FASN, CLS, Pennsylvania State University
Disclosures: Grant/Research Support: American Pecan Council, American Pistachio Growers, Hass Avocado Board, McCormick Spice Institute; Advisory Committee/Board Member: Heali, HumanN, Seafood Nutrition Partnership 

Kevin Maki, PhD, President and Chief Scientist, Midwest Biomedical Research, Addison, IL and Indiana University, Department of Applied Health Science, School of Public Health 
Disclosures: Consultant: Acasti Pharma Inc, Beren Therapeutics, Eli Lilly and Co., Naturmega, New Amsterdam Pharma, NorthSea Therapeutics, Novo Nordisk Pharma Inc.; Grant/Research Support: Pharmavite 

George McCabe, PhD, Purdue University 
No relevant financial relationship(s) with ineligible companies to disclose. 

Joshua Miller, PhD, Rutgers University
Disclosure(s): Consultant: Church & Dwight Co.; Independent Contractor: Church & Dwight Co. 

Kristina Petersen, PhD, APD, FAHA, Texas Tech University
Disclosure(s): Advisory Committee/Board Member: McCormick Science Institute; Grant/Research Support: McCormick Science Institute 

Connie Weaver, PhD, San Diego State University
No relevant financial relationship(s) with ineligible companies to disclose. 

Staff 

Michelle Crispino, American Society for Nutrition 
No relevant financial relationship(s) with ineligible companies to disclose. 

Gwen Twillman, American Society for Nutrition 
No relevant financial relationship(s) with ineligible companies to disclose. 

Through this special collection, learners will be able to download a certificate for each completed individual course. Separate certificates will be available for:

  • Designing and Conducting Human Nutrition RCTs
  • Laboratory Management and Statistical Analysis Plans for Clinical Nutrition Studies

Available Credit

  • 6.50 Attendance

    Learners are eligible to download a Certificate of Attendance upon activity completion. A Certificate of Attendance confirms the learner has completed the activity and does not confer any continuing education credit to the learner from ASN.

 
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$30.00Included
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$30.00Included
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Price

Cost:
$60.00
Please login or register to take this course.
Special ASN Member Benefit - 50% Off for Members!

ASN members receive this course for 50% off. Login now to get the $30 special member rate. If you do not see the member rate displayed for you after logging in, please contact discover@nutrition.org.

Not an ASN member? Click here to join ASN to receive member rates on all DiscoverNUTRITION products!