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Good People Working on Good Projects with Good Process

Case Study 3: Clinical Trial Management


Situation A leading smoothie type beverage supplier wanted to make a claim about weight loss regarding their beverage. In order to make product claims, they required scientific substantiation.
Frestedt Approach
  • Selected and trained company on appropriate claims
  • Defined the trial design and developed the protocol
  • Created informed consent, CRF, source documents
  • Created database and statistical analysis plan
  • Selected IRB, and submitted and tracked all documentation through IRB approval
  • Generated a recruitment campaign and enrolled all study subjects
  • Conducted the trial within Alimentix: The Minnesota Diet Research Center
  • Wrote final study report and authored several abstracts and a manuscript for publication
  • Won several awards for this work
Results Frestedt Inc. designed the clinical trial with an intended goal for subjects to safely lose approximately 1 pound of excess weight per week. During the 12 week trial, study subjects (on average) lost the expected weight, stated they were not hungry and they felt satiated (which were measured attributes followed during the trial). At the request of the sponsor, an abstract for a poster presentation and manuscript were submitted. The poster was presented at a national clinical research conference, and was a finalist in the poster competition.


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