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Nutrition Beverage Tolerance Study

Phase 2
Completed
Conditions
Human Volunteers
Interventions
Other: Nutritional Beverage
Registration Number
NCT01464385
Lead Sponsor
Abbott Nutrition
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
121
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

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Nutritional Beverage #2Nutritional BeverageNutritional Beverage with an amino acid Oral 237 ml
Nutritional Beverage #3Nutritional BeverageNutritional Beverage with an amino acid Oral 237 ml
Nutritional Beverage #1Nutritional BeverageNutritional Beverage Oral 237 ml
Primary Outcome Measures
NameTimeMethod
Proportion of subjects experiencing neurologic adverse event(s)2-3 weeks
Secondary Outcome Measures
NameTimeMethod
Proportion of subjects experiencing any adverse event(s).2-3 Weeks

Trial Locations

Locations (1)

The National Food Lab

🇺🇸

Livermore, California, United States

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