Human Volunteers Clinical Trial
Official title:
Nutrition Beverage Tolerance Study
Verified date | April 2012 |
Source | Abbott Nutrition |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
To evaluate the sensations experienced by subjects consuming a nutritional beverage.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The National Food Lab | Livermore | California |
Lead Sponsor | Collaborator |
---|---|
Abbott Nutrition |
United States,
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 |
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