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The Minnesota Diet Research Center

Case Study 1: Clinical Trial for Glucose/Insulin Management


Situation Leading food ingredient company desired “gold standard” claim substantiation evidence supporting the claim: Product X improves human glucose/insulin management.
Task Develop, execute, publicize “world class” clinical trial supporting intended claim.
Actions Taken Designed randomized, double-blind, placebo-controlled trial; selected clinical trial sites and specialized study experts; designed diet plans and nutritional counseling activities to maintain subject weight; and monitored study sites.
Results Isolate the effects of the investigative product on glucose/insulin levels in healthy, hyperglycemic individuals; analyzed data (including diet diaries using specialized nutritional software) and completed comprehensive publication strategy to communicate results.
Benefit 1 Expertise added to corporate team : Alimentix provided subject matter expertise (company lacked knowledge/experience designing, developing and running clinical trials and this trial required specialized, nutritional counseling, diet analysis and laboratory medicine expertise).
Benefit 2 Flexibility added to trial execution: Alimentix added a second site to increase subject recruitment activities and reduced time to completion of trial.
Benefit 3 Prestige added to product visibility: Alimentix published results in 5 food-related conferences (4 US, 1 international) and 2 peer-reviewed journals.