Clinical Trials Logo

Clinical Trial Summary

This study evaluates if a single oral dose of 150 mg of the novel food ingredient (AME001, R,R-monatin) does not have an effect on the Fridericia-corrected QT ECG interval (QTcF) exceeding 10 milliseconds (msec). Each subject will consume test article (150 mg), placebo, and moxifloxacin (400 mg; positive control) in each of 3 treatment periods.


Clinical Trial Description

This study is specifically designed to evaluate the potential effects of ingestion of the novel food ingredient on cardiac safety. The objective will be fulfilled by assessing cardiac parameters including heart rate, blood pressure, and ECG/QT interval in healthy adult male subjects following a single dose oral administration of the test article.

The primary objective of this study is to demonstrate that a single oral dose of 150 mg of the test article does not have an effect on the Fridericia-corrected QT ECG interval (QTcF) exceeding 10 milliseconds (msec). ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


NCT number NCT02616913
Study type Interventional
Source Cargill
Contact
Status Completed
Phase N/A
Start date March 2013
Completion date October 2013

See also
  Status Clinical Trial Phase
Suspended NCT05542238 - The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury N/A
Active, not recruiting NCT02973126 - Heartflow (AFFECTS) Phase 3
Withdrawn NCT00844935 - Electrocardiographic Autonomic Function Measures in Mechanically Ventilated Patients N/A
Completed NCT01410487 - Effects of Weight Loss on Cardio-respiratory Function N/A
Withdrawn NCT00807274 - Renal Function in Adults With Congenital Heart Disease. N/A
Withdrawn NCT00468702 - Postoperative Canadian Oral Anticoagulation Self-management (Post-COAGS) Trial N/A
Completed NCT04340388 - Contribution of Dolutegravir to Obesity and Cardiovascular Disease Phase 4
Completed NCT03758092 - Cardiovascular Screening in Infants Born Small for Gestational Age
Completed NCT03545672 - Early Identification of Myocardial Impairment in PBC
Recruiting NCT06091384 - Inspiratory Muscle Strength Training in Post-Covid Syndrome N/A
Completed NCT04586894 - Adverse Myocardial and Vascular Side Effects of Immune Checkpoint Inhibitors
Completed NCT03826914 - The Effects of the Dietary Supplement CardioFlex Q10 on Reducing Cardiovascular Disease Risk Factors in Adults N/A
Not yet recruiting NCT05624255 - Correlating the Measure of Retinal Vascular Density Through Angio-OCT With Calcium Score N/A
Completed NCT02966028 - Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD) Phase 2
Completed NCT01820702 - Short Term Bed Rest Study: Evaluation of the Use of Artificial Gravity, Induced by Short-arm Centrifugation N/A
Recruiting NCT04766203 - Relative Energy Deficiency in Sport Multicenter Study N/A
Completed NCT01811667 - Efficacy and Safety of the Mammalian Target of Rapamycin (mTor Rapamycin) Inhibitor in Vascular Malformations Phase 3
Terminated NCT02351726 - Mitroflow DL Post Approval Study- North America N/A
Completed NCT00901394 - Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia N/A
Completed NCT03354689 - Transcutaneous Electrical Nerve Stimulation and Cardiac Sympathetic Overdrive in Heart Failure