Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01464385
Other study ID # BK98
Secondary ID
Status Completed
Phase Phase 2
First received November 1, 2011
Last updated April 30, 2012
Start date October 2011
Est. completion date December 2011

Study information

Verified date April 2012
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To evaluate the sensations experienced by subjects consuming a nutritional beverage.


Recruitment information / eligibility

Status Completed
Enrollment 121
Est. completion date December 2011
Est. primary completion date November 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 45 Years and older
Eligibility Inclusion Criteria:

Subject = 45 years of age.

If female, subject is either postmenopausal for at least 1 year or surgically sterile

Subject reports that he/she has not participated in a research study in the last three months.

Exclusion Criteria:

Subject has active metabolic or endocrine disease

Subject has an autoimmune disorder

Subject has a disorder of gastrointestinal tract or any gastrointestinal surgery in past 12 months.

Subject has food allergy, celiac disease or intolerance to any of the ingredients in the study products

Subject reports history of parasthesia; and/or is currently taking medication/dietary supplements/substances that may cause parasthesia for 4 weeks prior to screening

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
Nutritional Beverage
Nutritional Beverage Oral 237mL
Nutritional Beverage
Nutritional Beverage Oral 237 mL
Nutritional Beverage
Nutritional Beverage Oral 237mL

Locations

Country Name City State
United States The National Food Lab Livermore California

Sponsors (1)

Lead Sponsor Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of subjects experiencing neurologic adverse event(s) 2-3 weeks Yes
Secondary Proportion of subjects experiencing any adverse event(s). 2-3 Weeks Yes
See also
  Status Clinical Trial Phase
Completed NCT03093506 - Effects of Micro-dose and Low-dose Recombinant Human Erythropoietin on Mitochondrial Function and Cognitive Performance Early Phase 1
Completed NCT00526968 - The Effects of a Novel NMDA NR2B-Subtype Selective Antagonist, EVT 101, on Brain Function Phase 1
Completed NCT03277456 - A Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine MVA-NP+M1 Early Phase 1
Completed NCT02922933 - A Study to Examine the Effect of Omeprazole, Famotidine, and an Acidic Beverage on the Pharmacokinetics of Entinostat in Healthy Adult Subjects Phase 1
Completed NCT01452425 - In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome Phase 1
Completed NCT01468714 - A Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Pf-04937319 In Healthy Subjects Phase 1
Completed NCT02922946 - Study to Determine the Effect of the Timing of a Meal on the Pharmacokinetics of Entinostat Phase 1
Completed NCT00254449 - Effect of NGX-4010 on ENFD and Sensory Function Phase 1
Completed NCT01618877 - A Randomized, Double-blind, Pharmacokinetics Study to Assess Safety, Tolerability of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of Bid Dosing in Chinese Healthy Volunteers Phase 1
Completed NCT01618903 - An Open-label, Bioequivalence Study to Evaluate LEV Administered as a 45-min Intravenous Infusion and Same Dosage LEV Oral Tablet in Chinese Phase 1
Completed NCT00752466 - A Drug Interaction Study of the Pharmacokinetics of Topiramate and FLUNARIZINE When Given Together or Separately Phase 1
Completed NCT00166933 - Minimal Erythema Dose of UV-B in Normal Population of Taiwan N/A
Completed NCT05519514 - Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult Subjects Phase 1
Completed NCT01776437 - Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male Volunteers Phase 1
Completed NCT01437033 - Breath Test for Chemicals (Volatile Organic Compounds)
Completed NCT01445860 - Drug-Drug Interaction Study Of Effect Of PF-03882845 On Simvastatin Pharmacokinetics Phase 1
Completed NCT00744809 - TMC278-TiDP6-C152: A Study to Assess the Effects of TMC278 and Efavirenz (EFV) on the QT/QTc Interval (Heart Conduction and Heart Rhythm) in Healthy Volunteers. Phase 1
Unknown status NCT00743977 - Bioequivalence of Phenazopyridine HCl in Healthy Volunteers N/A