Human Volunteers
Conditions
Brief summary
To evaluate the sensations experienced by subjects consuming a nutritional beverage.
Interventions
OTHERNutritional Beverage
Nutritional Beverage Oral 237mL
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects experiencing neurologic adverse event(s) | 2-3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects experiencing any adverse event(s). | 2-3 Weeks |
Countries
United States
Outcome results
None listed